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Rosuvastatin | CAS No: 287714-41-4 | GMP-certified suppliers
A medication that supports management of hyperlipidemia and related dyslipidemias while helping reduce cardiovascular event risk in patients inadequately controlled by diet and lifestyle measures.
Therapeutic categories
Agents Causing Muscle ToxicityAlimentary Tract and MetabolismAmidesAnticholesteremic AgentsBCRP/ABCG2 SubstratesBSEP/ABCB11 Substrates
Generic name
Rosuvastatin
Molecule type
small molecule
CAS number
287714-41-4
DrugBank ID
DB01098
Approval status
Approved drug
ATC code
C10BX10
Primary indications
- The FDA monograph states that rosuvastatin is indicated as an adjunct to diet in the treatment of triglyceridemia, Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia), and Homozygous Familial Hypercholesterolemia
- The Health Canada monograph for rosuvastatin further specifies that rosuvastatin is indicated for the reduction of elevated total cholesterol (Total-C), LDL-C, ApoB, the Total-C/HDL-C ratio and triglycerides (TG) and for increasing HDL-C in hyperlipidemic and dyslipidemic conditions when response to diet and exercise alone has been inadequate
- It is also indicated for the prevention of major cardiovascular events (including risk of myocardial infarction, nonfatal stroke, and coronary artery revascularization) in adult patients without documented history of cardiovascular or cerebrovascular events, but with at least two conventional risk factors for cardiovascular disease
Product Snapshot
- Oral small‑molecule statin supplied mainly as coated or film‑coated tablets and capsules
- Used for management of hyperlipidemia and other dyslipidemias and for cardiovascular risk reduction
- Approved in major regulated markets including the US and Canada
Clinical Overview
Rosuvastatin (CAS 287714-41-4) is a synthetic phenylpyrimidine statin used globally for the management of dyslipidemia and for cardiovascular risk reduction. It is indicated as adjunctive therapy to diet for hypertriglyceridemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia. Regulatory approvals also support its use to reduce LDL‑C, total cholesterol, ApoB, and triglycerides, and to increase HDL‑C in patients with inadequate response to lifestyle measures. In primary prevention, it is used in adults with established risk factors for cardiovascular disease. Crestor is the most recognized brand.
Rosuvastatin competitively inhibits HMG‑CoA reductase, decreasing hepatic cholesterol synthesis and upregulating LDL receptors, which enhances LDL and VLDL clearance. It is hydrophilic and exhibits selective hepatic uptake via OATP1B1, with limited passive diffusion. Low systemic bioavailability reflects significant first‑pass hepatic extraction. Metabolism is minimal and primarily via CYP2C9, reducing susceptibility to CYP‑mediated drug interactions. Rosuvastatin is a substrate for OATP1B1 and BCRP transporters. Elimination occurs largely unchanged in feces, with a terminal half‑life of approximately 19 hours reported in clinical evaluations.
Statin pharmacodynamic activity includes reductions in LDL‑C, non‑HDL‑C, ApoB, and triglycerides with concurrent increases in HDL‑C. Experimental data describe pleiotropic effects such as improved endothelial function and modulation of inflammatory pathways, although these findings do not alter approved clinical indications.
Safety considerations include dose‑dependent risks of myopathy and rare rhabdomyolysis, particularly at the 40 mg dose or when combined with interacting agents such as gemfibrozil, cyclosporine, or certain protease inhibitors. Mild, reversible transaminase increases have been observed. Statins may raise fasting glucose or HbA1c in some patients. Effects on Lp(a) may vary with apo(a) phenotype.
For API procurement, manufacturers should ensure control of enantiomeric purity, transporter‑interaction risk, and consistency in particle size and polymorphic form, supported by full regulatory documentation and traceable GMP compliance.
Rosuvastatin competitively inhibits HMG‑CoA reductase, decreasing hepatic cholesterol synthesis and upregulating LDL receptors, which enhances LDL and VLDL clearance. It is hydrophilic and exhibits selective hepatic uptake via OATP1B1, with limited passive diffusion. Low systemic bioavailability reflects significant first‑pass hepatic extraction. Metabolism is minimal and primarily via CYP2C9, reducing susceptibility to CYP‑mediated drug interactions. Rosuvastatin is a substrate for OATP1B1 and BCRP transporters. Elimination occurs largely unchanged in feces, with a terminal half‑life of approximately 19 hours reported in clinical evaluations.
Statin pharmacodynamic activity includes reductions in LDL‑C, non‑HDL‑C, ApoB, and triglycerides with concurrent increases in HDL‑C. Experimental data describe pleiotropic effects such as improved endothelial function and modulation of inflammatory pathways, although these findings do not alter approved clinical indications.
Safety considerations include dose‑dependent risks of myopathy and rare rhabdomyolysis, particularly at the 40 mg dose or when combined with interacting agents such as gemfibrozil, cyclosporine, or certain protease inhibitors. Mild, reversible transaminase increases have been observed. Statins may raise fasting glucose or HbA1c in some patients. Effects on Lp(a) may vary with apo(a) phenotype.
For API procurement, manufacturers should ensure control of enantiomeric purity, transporter‑interaction risk, and consistency in particle size and polymorphic form, supported by full regulatory documentation and traceable GMP compliance.
Identification & chemistry
| Generic name | Rosuvastatin |
|---|---|
| Molecule type | Small molecule |
| CAS | 287714-41-4 |
| UNII | 413KH5ZJ73 |
| DrugBank ID | DB01098 |
Pharmacology
| Summary | Rosuvastatin is a competitive inhibitor of HMG‑CoA reductase that reduces hepatic cholesterol synthesis, driving upregulation of LDL receptors and enhancing clearance of LDL and VLDL particles. Its primary pharmacodynamic effect is broad lipid modification, characterized by lowered LDL‑C, VLDL, and triglycerides with secondary increases in HDL‑C. Beyond lipid lowering, rosuvastatin shows ancillary vascular and immunomodulatory actions, including effects on endothelial function, nitric oxide availability, and LFA‑1–mediated leukocyte activity. |
|---|---|
| Mechanism of action | Rosuvastatin is a statin medication and a competitive inhibitor of the enzyme HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase, which catalyzes the conversion of HMG-CoA to mevalonate, an early rate-limiting step in cholesterol biosynthesis.Rosuvastatin acts primarily in the liver, where decreased hepatic cholesterol concentrations stimulate the upregulation of hepatic low density lipoprotein (LDL) receptors which increases hepatic uptake of LDL. Rosuvastatin also inhibits hepatic synthesis of very low density lipoprotein (VLDL).The overall effect is a decrease in plasma LDL and VLDL. In vitro and in vivo animal studies also demonstrate that rosuvastatin exerts vasculoprotective effects independent of its lipid-lowering properties, also known as the pleiotropic effects of statins.This includes improvement in endothelial function, enhanced stability of atherosclerotic plaques, reduced oxidative stress and inflammation, and inhibition of the thrombogenic response. Statins have also been found to bind allosterically to β2 integrin function-associated antigen-1 (LFA-1), which plays an important role in leukocyte trafficking and in T cell activation. Rosuvastatin exerts an anti-inflammatory effect on rat mesenteric microvascular endothelium by attenuating leukocyte rolling, adherence and transmigration.The drug also modulates nitric oxide synthase (NOS) expression and reduces ischemic-reperfusion injuries in rat hearts.Rosuvastatin increases the bioavailability of nitric oxideby upregulating NOSand by increasing the stability of NOS through post-transcriptional polyadenylation.It is unclear as to how rosuvastatin brings about these effects though they may be due to decreased concentrations of mevalonic acid. |
| Pharmacodynamics | Rosuvastatin is a synthetic, enantiomerically pure antilipemic agent. It is used to lower total cholesterol, low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apoB), non-high density lipoprotein-cholesterol (non-HDL-C), and trigleride (TG) plasma concentrations while increasing HDL-C concentrations. High LDL-C, low HDL-C and high TG concentrations in the plasma are associated with increased risk of atherosclerosis and cardiovascular disease. The total cholesterol to HDL-C ratio is a strong predictor of coronary artery disease and high ratios are associated with higher risk of disease. Increased levels of HDL-C are associated with lower cardiovascular risk. By decreasing LDL-C and TG and increasing HDL-C, rosuvastatin reduces the risk of cardiovascular morbidity and mortality. Elevated cholesterol levels, and in particular, elevated low-density lipoprotein (LDL) levels, are an important risk factor for the development of CVD.Use of statins to target and reduce LDL levels has been shown in a number of landmark studies to significantly reduce the risk of development of CVD and all-cause mortality.Statins are considered a cost-effective treatment option for CVD due to their evidence of reducing all-cause mortality including fatal and non-fatal CVD as well as the need for surgical revascularization or angioplasty following a heart attack.Evidence has shown that even for low-risk individuals (with <10% risk of a major vascular event occurring within 5 years) statins cause a 20%-22% relative reduction in major cardiovascular events (heart attack, stroke, coronary revascularization, and coronary death) for every 1 mmol/L reduction in LDL without any significant side effects or risks. **Skeletal Muscle Effects** Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including rosuvastatin. These risks can occur at any dose level, but are increased at the highest dose (40 mg). Rosuvastatin should be prescribed with caution in patients with predisposing factors for myopathy (e.g., age ≥ 65 years, inadequately treated hypothyroidism, renal impairment). The risk of myopathy during treatment with rosuvastatin may be increased with concurrent administration of some other lipid-lowering therapies (such as [fenofibrate] or [niacin]), [gemfibrozil], [cyclosporine], [atazanavir]/[ritonavir], [lopinavir]/ritonavir, or [simeprevir]. Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors, including rosuvastatin, coadministered with [colchicine], and caution should therefore be exercised when prescribing these two medications together. Real-world data from observational studies has suggested that 10-15% of people taking statins may experience muscle aches at some point during treatment. **Liver Enzyme Abnormalities** Increases in serum transaminases have been reported with HMG-CoA reductase inhibitors, including rosuvastatin. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy. There were two cases of jaundice, for which a relationship to rosuvastatin therapy could not be determined, which resolved after discontinuation of therapy. There were no cases of liver failure or irreversible liver disease in these trials. **Endocrine Effects** Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including rosuvastatin calcium tablets. Based on clinical trial data with rosuvastatin, in some instances these increases may exceed the threshold for the diagnosis of diabetes mellitus. An in vitro study found that [atorvastatin], [pravastatin], [rosuvastatin], and [pitavastatin] exhibited a dose-dependent cytotoxic effect on human pancreas islet β cells, with reductions in cell viability of 32, 41, 34 and 29%, respectively, versus control]. Moreover, insulin secretion rates were decreased by 34, 30, 27 and 19%, respectively, relative to control. HMG-CoA reductase inhibitors interfere with cholesterol synthesis and lower cholesterol levels and, as such, might theoretically blunt adrenal or gonadal steroid hormone production. Rosuvastatin demonstrated no effect upon nonstimulated cortisol levels and no effect on thyroid metabolism as assessed by TSH plasma concentration. In rosuvastatin treated patients, there was no impairment of adrenocortical reserve and no reduction in plasma cortisol concentrations. Clinical studies with other HMG-CoA reductase inhibitors have suggested that these agents do not reduce plasma testosterone concentration. The effects of HMG-CoA reductase inhibitors on male fertility have not been studied. The effects, if any, on the pituitarygonadal axis in premenopausal women are unknown. **Cardiovascular** Ubiquinone levels were not measured in rosuvastatin clinical trials, however significant decreases in circulating ubiquinone levels in patients treated with other statins have been observed. The clinical significance of a potential long-term statin-induced deficiency of ubiquinone has not been established. It has been reported that a decrease in myocardial ubiquinone levels could lead to impaired cardiac function in patients with borderline congestive heart failure. **Lipoprotein A** In some patients, the beneficial effect of lowered total cholesterol and LDL-C levels may be partly blunted by a concomitant increase in the Lipoprotein(a) [Lp(a)] concentrations. Present knowledge suggests the importance of high Lp(a) levels as an emerging risk factor for coronary heart disease. It is thus desirable to maintain and reinforce lifestyle changes in high-risk patients placed on rosuvastatin therapy.Further studies have demonstrated statins affect Lp(a) levels differently in patients with dyslipidemia depending on their apo(a) phenotype; statins increase Lp(a) levels exclusively in patients with the low molecular weight apo(a) phenotype. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 3-hydroxy-3-methylglutaryl-coenzyme A reductase | Humans | inhibitor |
| Integrin alpha-L | Humans | inhibitory allosteric modulator |
ADME / PK
| Absorption | In a study of healthy white male volunteers, the absolute oral bioavailability of rosuvastatin was found to be approximately 20% while absorption was estimated to be 50%, which is consistent with a substantial first-pass effect after oral dosing.Another study in healthy volunteers found that the peak plasma concentration (Cmax) of rosuvastatin was 6.06ng/mL and was reached at a median of 5 hours following oral dosing.Both Cmax and AUC increased in approximate proportion to dose. Neither food nor evening versus morning administration was shown to have an effect on the AUC of rosuvastatin.Many statins are known to interact with hepatic uptake transporters and thus reach high concentrations at their site of action in the liver. Breast Cancer Resistance Protein (BCRP) is a membrane-bound protein that plays an important role in the absorption of rosuvastatin, particularly as CYP3A4 has minimal involvement in its metabolism.Evidence from pharmacogenetic studies of c.421C>A single nucleotide polymorphisms (SNPs) in the gene for BCRP has demonstrated that individuals with the 421AA genotype have reduced functional activity and 2.4-fold higher AUC and Cmax values for rosuvastatin compared to study individuals with the control 421CC genotype. This has important implications for the variation in response to the drug in terms of efficacy and toxicity, particularly as the BCRP c.421C>A polymorphism occurs more frequently in Asian populations than in Caucasians.Other statin drugs impacted by this polymorphism include [fluvastatin] and [atorvastatin]. Genetic differences in the OATP1B1 (organic-anion-transporting polypeptide 1B1) hepatic transporter have also been shown to impact rosuvastatin pharmacokinetics. Evidence from pharmacogenetic studies of the c.521T>C SNP showed that rosuvastatin AUC was increased 1.62-fold for individuals homozygous for 521CC compared to homozygous 521TT individuals.Other statin drugs impacted by this polymorphism include [simvastatin], [pitavastatin], [atorvastatin], and [pravastatin]. For patients known to have the above-mentioned c.421AA BCRP or c.521CC OATP1B1 genotypes, a maximum daily dose of 20mg of rosuvastatin is recommended to avoid adverse effects from the increased exposure to the drug, such as muscle pain and risk of rhabdomyolysis. |
|---|---|
| Half-life | The elimination half-life (t½) of rosuvastatin is approximately 19 hours and does not increase with increasing doses. |
| Protein binding | Rosuvastatin is 88% bound to plasma proteins, mostly albumin. This binding is reversible and independent of plasma concentrations. |
| Metabolism | Rosuvastatin is not extensively metabolized, as demonstrated by the small amount of radiolabeled dose that is recovered as a metabolite (~10%). Cytochrome P450 (CYP) 2C9 is primarily responsible for the formation of rosuvastatin's major metabolite, N-desmethylrosuvastatin, which has approximately 20-50% of the pharmacological activity of its parent compound in vitro.However, this metabolic pathway isn't deemed to be clinically significant as there were no observable effects found on rosuvastatin pharmacokinetics when rosuvastatin was coadministered with fluconazole, a potent CYP2C9 inhibitor. In vitro and in vivo data indicate that rosuvastatin has no clinically significant cytochrome P450 interactions (as substrate, inhibitor or inducer). Consequently, there is little potential for drug-drug interactions upon coadministration with agents that are metabolized by cytochrome P450. |
| Route of elimination | Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is recovered as metabolite. Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces (90%). After an intravenous dose, approximately 28% of total body clearance was via the renal route, and 72% by the hepatic route. A study in healthy adult male volunteers found that approximately 90% of the rosuvastatin dose was recovered in feces within 72 hours after dose, while the remaining 10% was recovered in urine. The drug was completely excreted from the body after 10 days of dosing. They also found that approximately 76.8% of the excreted dose was unchanged from the parent compound, with the remaining dose recovered as the metabolites n-desmethyl rosuvastatin and rosuvastatin-5S-lactone. Renal tubular secretion is responsible for >90% of total renal clearance, and is believed to be mediated primarily by the uptake transporter OAT3 (Organic anion transporter 1), while OAT1 had minimal involvement. |
| Volume of distribution | Rosuvastatin undergoes first-pass extraction in the liver, which is the primary site of cholesterol synthesis and LDL-C clearance. The mean volume of distribution at steady-state of rosuvastatin is approximately 134 litres. |
Formulation & handling
- Oral small‑molecule API with low aqueous solubility, generally formulated as film‑coated tablets or capsules to aid manufacturability and prevent moisture uptake.
- BCS class II–like solubility profile may require particle‑size control or solubility‑enhancing approaches (e.g., salts, solid dispersions) to support consistent oral absorption.
- Food has minimal impact on absorption, allowing flexible administration without special feeding‑related instructions for formulation design.
Regulatory status
| Lifecycle | Most core U.S. and Canadian patents expired between 2012 and 2022, indicating the API is in a mature post‑patent phase in both markets. With protection lapsed in all listed jurisdictions, the product is positioned for established generic presence in Canada and the United States. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Rosuvastatin was developed by a single originator company, with a broad network of repackagers and distributors now supporting supply. Branded products are established in major markets such as the United States and Canada, with availability in other regions through international counterparts. Key patents in the US and Canada have expired, indicating that generic competition is already well established. |
|---|
Safety
| Toxicity | Generally well-tolerated. Side effects may include myalgia, constipation, asthenia, abdominal pain, and nausea. Other possible side effects include myotoxicity (myopathy, myositis, rhabdomyolysis) and hepatotoxicity. To avoid toxicity in Asian patients, lower doses should be considered. Pharmacokinetic studies show an approximately two-fold increase in peak plasma concentration and AUC in Asian patients (Philippino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian descent) compared to Caucasian patients. |
|---|
High Level Warnings:
- Reported adverse effects include myalgia, constipation, asthenia, abdominal discomfort, and nausea
- Severe myotoxicity (myopathy, myositis, rhabdomyolysis) and hepatotoxicity have been observed at higher exposure levels
- Pharmacokinetic data show roughly two‑fold higher Cmax and AUC in Asian subjects, indicating increased systemic exposure relative to Caucasian subjects
Rosuvastatin is a type of Statins
Statins are a widely prescribed class of pharmaceutical active ingredients (APIs) used for the treatment of high cholesterol and prevention of cardiovascular diseases. These medications work by inhibiting the enzyme HMG-CoA reductase, which plays a crucial role in the production of cholesterol in the liver.
Statins are categorized as lipid-lowering agents and are highly effective in reducing levels of low-density lipoprotein (LDL) cholesterol, often referred to as "bad" cholesterol. By decreasing LDL cholesterol, statins help to prevent the formation of plaque in the arteries, reducing the risk of heart attacks and strokes.
There are several popular statins available on the market, including atorvastatin, simvastatin, rosuvastatin, and pravastatin. Each statin differs in terms of potency, dosing, and potential drug interactions, allowing healthcare professionals to select the most appropriate option for individual patients.
Statins are typically taken orally in the form of tablets or capsules and are available in different strengths. The dosage is determined by various factors such as the patient's cholesterol levels, cardiovascular risk, and response to treatment.
While statins are generally well-tolerated, they can have side effects such as muscle pain, liver dysfunction, and gastrointestinal disturbances. However, these side effects are relatively rare and are outweighed by the significant cardiovascular benefits of statin therapy.
In conclusion, statins are a vital subclass of pharmaceutical APIs used for managing high cholesterol and reducing the risk of cardiovascular diseases. They effectively lower LDL cholesterol levels and are an essential component of treatment plans for individuals with hyperlipidemia or a high risk of heart disease.
Rosuvastatin (Statins), classified under Lipid-lowering agents
Lipid-lowering agents are a category of pharmaceutical active ingredients (APIs) that are widely used in the treatment of hyperlipidemia, a condition characterized by elevated levels of lipids (such as cholesterol and triglycerides) in the blood. These agents play a crucial role in managing lipid abnormalities and reducing the risk of cardiovascular diseases.
One of the most commonly prescribed lipid-lowering agents is statins. Statins work by inhibiting an enzyme called HMG-CoA reductase, which is responsible for the production of cholesterol in the liver. By blocking this enzyme, statins effectively lower cholesterol levels in the bloodstream.
Another class of lipid-lowering agents is fibric acid derivatives, which primarily target triglyceride levels. These agents activate a nuclear receptor known as PPAR-alpha, which regulates lipid metabolism. By activating PPAR-alpha, fibric acid derivatives enhance the breakdown of triglycerides and increase the elimination of fatty acids from the bloodstream.
Additionally, bile acid sequestrants are often used as lipid-lowering agents. These agents bind to bile acids in the intestine, preventing their reabsorption. As a result, the liver utilizes more cholesterol to produce new bile acids, leading to a decrease in circulating cholesterol levels.
Lipid-lowering agents are available in various formulations, including tablets, capsules, and suspensions, allowing for convenient administration. They are usually prescribed alongside lifestyle modifications, such as dietary changes and regular exercise, to optimize the management of hyperlipidemia.
It is important to note that the use of lipid-lowering agents should be under the supervision of a healthcare professional, as they may have potential side effects and interactions with other medications. Proper monitoring of lipid levels and regular follow-up visits are essential for ensuring the effectiveness and safety of these pharmaceutical agents.
Rosuvastatin API manufacturers & distributors
Compare qualified Rosuvastatin API suppliers worldwide. We currently have 47 companies offering Rosuvastatin API, with manufacturing taking place in 9 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| API Corp. | Producer | Japan | Japan | CEP, CoA, GMP, JDMF | 11 products |
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 229 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Atom Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 14 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 250 products |
| AXXO GmbH | Distributor | Germany | World | CEP, CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Biocon | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 36 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF, WC | 235 products |
| Changzhou Pharma | Producer | China | China | CEP, CoA, USDMF, WC | 9 products |
| Changzhou Pharmaceutical ... | Producer | China | China | CEP, CoA, GMP | 3 products |
| G.C. Chemie Pharmie Ltd | Producer | India | India | CoA | 21 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hanmi Fine Chemical | Producer | South Korea | South Korea | CoA, JDMF | 18 products |
| Hari Ganesh Pharma Privat... | Distributor | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, MSDS | 35 products |
| HEC Pharm | Producer | Germany | Unknown | CEP, CoA, GMP, USDMF, WC | 31 products |
| Hetero Drugs | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 98 products |
| Humble Healthcaare | Producer | India | India | CoA | 30 products |
| Jeil Pharmaceutical | Producer | South Korea | South Korea | CoA, JDMF | 12 products |
| Jiangxi Aifeimu Technolog... | Producer | China | China | CoA | 7 products |
| Kolon Life Science | Producer | South Korea | South Korea | CoA, JDMF, USDMF | 32 products |
| Lee Pharma | Producer | India | India | CoA, FDA, GMP, ISO9001, USDMF, WC, WHO-GMP | 21 products |
| Lek Pharma | Producer | Slovenia | India | CoA, USDMF | 32 products |
| Lupin | Producer | India | India | CoA, GMP, JDMF, USDMF, WC | 155 products |
| Menovo | Producer | China | China | CEP, CoA, EDMF/ASMF, FDA, GMP, USDMF | 27 products |
| Morepen Laboratories Ltd. | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, MSDS, USDMF, WC | 22 products |
| MSN Labs. | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 119 products |
| Mylan | Producer | India | India | CoA, GMP, JDMF, USDMF, WC | 201 products |
| Nantong Chanyoo | Producer | China | China | CoA, WC | 2 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Rui Laboratories Private ... | Producer | India | India | BSE/TSE, CoA, GDP, GMP, ISO9001, MSDS, USDMF, WHO-GMP | 3 products |
| Saintsun Pharma Co Ltd | Producer | China | China | CoA | 2 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shanghai Desano Chem. | Producer | China | China | CoA, USDMF | 22 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Signa | Producer | Mexico | Mexico | CoA, USDMF | 42 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Sun Pharma | Producer | India | India | CEP, CoA, GMP, USDMF | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Yungjin Pharmaceutical | Producer | South Korea | South Korea | CoA, JDMF | 10 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF | 69 products |
| Zhejiang Hongyuan | Producer | China | China | CoA | 7 products |
| Zhejiang Jiangbei | Producer | China | China | CoA | 7 products |
| Zhejiang Neo-Dankong | Producer | China | China | CoA, JDMF, USDMF | 8 products |
When sending a request, specify which Rosuvastatin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Rosuvastatin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Rosuvastatin API
Sourcing
What matters most when sourcing GMP-grade Rosuvastatin?
When sourcing GMP‑grade Rosuvastatin, the priority is verifying compliance with applicable Canadian and US regulatory standards. Suppliers should have consistent GMP documentation and traceability, particularly given the broad network of repackagers and distributors in the market. Because patents have expired and generics are well established, confirming the manufacturer’s quality controls and supply chain integrity is essential.
Which documents are typically required when sourcing Rosuvastatin API?
Request the core API documentation set: CoA (46 companies), GMP (26 companies), USDMF (24 companies), CEP (18 companies), WC (14 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Rosuvastatin API?
Known or reported manufacturers for Rosuvastatin: Changzhou Comwin Fine Chemicals Co., Ltd, Apino Pharma Co., Ltd., Aurora Industry Co., Ltd, Tresinde Biotech, Global Pharma Tek, SETV Global, Sinoway industrial Co.,Ltd, Apollo Healthcare Resources (Singapore), Morepen Laboratories Ltd., AXXO GmbH, Tenatra Exports Private Limited, Hari Ganesh Pharma Private Limited, Rochem International, Inc., Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Rosuvastatin API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Rosuvastatin manufacturers?
Audit reports may be requested for Rosuvastatin: 10 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Rosuvastatin API on Pharmaoffer?
Reported supplier count for Rosuvastatin: 46 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Rosuvastatin API?
Production countries reported for Rosuvastatin: India (19 producers), China (16 producers), South Korea (4 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Rosuvastatin usually hold?
Common certifications for Rosuvastatin suppliers: CoA (46 companies), GMP (26 companies), USDMF (24 companies), CEP (18 companies), WC (14 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Rosuvastatin (CAS 287714-41-4) used for?
Rosuvastatin is used to manage dyslipidemia and to reduce cardiovascular risk. It lowers LDL‑C, total cholesterol, ApoB, and triglycerides, and increases HDL‑C as adjunctive therapy to diet. It is also indicated for hypertriglyceridemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, and is used in primary prevention for adults with established cardiovascular risk factors.
Which therapeutic class does Rosuvastatin fall into?
Rosuvastatin belongs to the following therapeutic categories: Agents Causing Muscle Toxicity, Alimentary Tract and Metabolism, Amides, Anticholesteremic Agents, BCRP/ABCG2 Substrates. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Rosuvastatin mainly prescribed for?
The primary indications for Rosuvastatin: The FDA monograph states that Rosuvastatin is indicated as an adjunct to diet in the treatment of triglyceridemia, Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia), and Homozygous Familial Hypercholesterolemia, The Health Canada monograph for Rosuvastatin further specifies that Rosuvastatin is indicated for the reduction of elevated total cholesterol (Total-C), LDL-C, ApoB, the Total-C/HDL-C ratio and triglycerides (TG) and for increasing HDL-C in hyperlipidemic and dyslipidemic conditions when response to diet and exercise alone has been inadequate, It is also indicated for the prevention of major cardiovascular events (including risk of myocardial infarction, nonfatal stroke, and coronary artery revascularization) in adult patients without documented history of cardiovascular or cerebrovascular events, but with at least two conventional risk factors for cardiovascular disease. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Rosuvastatin work?
Rosuvastatin is a statin medication and a competitive inhibitor of the enzyme HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase, which catalyzes the conversion of HMG-CoA to mevalonate, an early rate-limiting step in cholesterol biosynthesis.Rosuvastatin acts primarily in the liver, where decreased hepatic cholesterol concentrations stimulate the upregulation of hepatic low density lipoprotein (LDL) receptors which increases hepatic uptake of LDL. Rosuvastatin also inhibits hepatic synthesis of very low density lipoprotein (VLDL).The overall effect is a decrease in plasma LDL and VLDL.
In vitro and in vivo animal studies also demonstrate that Rosuvastatin exerts vasculoprotective effects independent of its lipid-lowering properties, also known as the pleiotropic effects of statins.This includes improvement in endothelial function, enhanced stability of atherosclerotic plaques, reduced oxidative stress and inflammation, and inhibition of the thrombogenic response.
Statins have also been found to bind allosterically to β2 integrin function-associated antigen-1 (LFA-1), which plays an important role in leukocyte trafficking and in T cell activation.
Rosuvastatin exerts an anti-inflammatory effect on rat mesenteric microvascular endothelium by attenuating leukocyte rolling, adherence and transmigration.The drug also modulates nitric oxide synthase (NOS) expression and reduces ischemic-reperfusion injuries in rat hearts.Rosuvastatin increases the bioavailability of nitric oxideby upregulating NOSand by increasing the stability of NOS through post-transcriptional polyadenylation.It is unclear as to how Rosuvastatin brings about these effects though they may be due to decreased concentrations of mevalonic acid.
What should someone know about the safety or toxicity profile of Rosuvastatin?
Rosuvastatin is generally well tolerated, but common adverse effects include myalgia, constipation, asthenia, abdominal discomfort, and nausea. Dose‑dependent myotoxicity can occur, with rare cases of myopathy, myositis, or rhabdomyolysis, and higher systemic exposure—such as the two‑fold increase observed in Asian subjects—may increase this risk. Mild, reversible elevations in liver transaminases and small increases in fasting glucose or HbA1c have been reported. The risk of severe muscle injury is greater at the 40 mg dose or when combined with interacting agents such as gemfibrozil, cyclosporine, or certain protease inhibitors.
What are important formulation and handling considerations for Rosuvastatin as an API?
Important considerations include managing Rosuvastatin’s low aqueous solubility, which typically requires particle‑size control or solubility‑enhancing strategies to support consistent absorption. It is commonly formulated as film‑coated tablets or capsules to improve manufacturability and limit moisture uptake. Minimal food effects simplify dosing design, while the compound’s limited metabolism and high protein binding do not drive specific formulation constraints. Standard handling should minimize moisture exposure and maintain uniformity of the selected solid‑state form.
Is Rosuvastatin a small molecule?
Rosuvastatin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Rosuvastatin?
Oral Rosuvastatin is sensitive to moisture due to its low aqueous solubility, so formulations typically use film coating to limit moisture uptake and support manufacturability. Particle‑size control or solubility‑enhancing approaches may be needed to maintain consistent dissolution and absorption. No special stability concerns related to food effects are noted, as food does not meaningfully alter exposure.
Regulatory
Where is Rosuvastatin approved or in use globally?
Rosuvastatin is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Rosuvastatin right now?
Rosuvastatin is regulated for use in both Canada and the United States under their respective national drug approval frameworks. Patent oversight follows each country’s standard systems for pharmaceutical intellectual property, with protections and expirations determined by applicable statutory and regulatory processes.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Rosuvastatin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Rosuvastatin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Rosuvastatin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Rosuvastatin: 12058 verified transactions across 2258 suppliers and 865 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Rosuvastatin?
Market report availability for Rosuvastatin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
