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Risedronic acid | CAS No: 105462-24-6 | GMP-certified suppliers
A medication that treats and prevents osteoporosis in men and postmenopausal women, manages Paget’s disease, and addresses glucocorticoid-induced bone loss.
Therapeutic categories
Primary indications
- Risedronic acid is indicated for the treatment of osteoperosis in men, treatment of Paget's disease, treatment and prevention of osteoperosis in postmenopausal women, and treatment and prevention of glucocorticoid-induced osteoperosis
Product Snapshot
- Risedronic acid is formulated as oral small molecule tablets, including film-coated, effervescent, delayed-release, and granule forms
- It is primarily used for the treatment and prevention of osteoporosis, Paget's disease, and glucocorticoid-induced osteoporosis
- The product is approved for use in key regulatory markets including the United States and Canada
Clinical Overview
Pharmacodynamically, risedronic acid acts by selectively inhibiting osteoclast-mediated bone resorption. It is a pyridine-containing bisphosphonate that binds avidly to hydroxyapatite crystals in bone. During bone resorption, localized acidification leads to release of risedronic acid, which enters osteoclasts through fluid-phase endocytosis. Within osteoclasts, it inhibits farnesyl pyrophosphate synthase, a key enzyme in the mevalonate pathway. This inhibition disrupts prenylation of small GTPase signaling proteins, triggering osteoclast apoptosis and reducing bone turnover.
Key pharmacokinetic parameters include rapid uptake into bone tissue following oral administration, limited systemic bioavailability, and renal excretion of the unchanged drug. The affinity for bone hydroxyapatite results in prolonged skeletal retention, contributing to sustained antiresorptive effects.
Safety considerations encompass the risk of musculoskeletal adverse effects, potential for hypocalcemia, and rare occurrences of osteonecrosis of the jaw and atypical femoral fractures, consistent with other bisphosphonate class effects. Monitoring of calcium and vitamin D levels is recommended during therapy.
Risedronic acid is marketed under various global brand names for osteoporosis and Paget’s disease treatment. Its classification spans bone density conservation agents and drugs affecting bone structure and mineralization.
From an API sourcing perspective, ensuring pharmaceutical-grade purity and compliance with established pharmacopeial standards is critical. Suppliers should provide comprehensive documentation on synthetic route, impurity profiles, and stability data to meet regulatory quality requirements.
Identification & chemistry
| Generic name | Risedronic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 105462-24-6 |
| UNII | KM2Z91756Z |
| DrugBank ID | DB00884 |
Pharmacology
| Summary | Risedronic acid is a pyridine-based bisphosphonate that targets bone hydroxyapatite and farnesyl pyrophosphate synthase to inhibit osteoclast-mediated bone resorption. It localizes to bone and is internalized by osteoclasts, where it induces apoptosis through enzymatic inhibition. This results in decreased bone turnover, supporting its therapeutic use in metabolic bone diseases. |
|---|---|
| Mechanism of action | Risedronatic acid binds to bone hydroxyapatite. Bone resorption causes local acidification, releasing risedronic acid which is that taken into osteoclasts by fluid-phase endocytosis. Endocytic vesicles are acidified, releasing risedronic acid to the cytosol of osteoclasts where they induce apoptosis through inhbition of farnesyl pyrophosphate synthase. Inhibition of osteoclasts results in decreased bone resorption. |
| Pharmacodynamics | Risedronate is a pyridine-based bisphosphonate that inhibits bone resorption caused by osteoclasts. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Hydroxylapatite | Humans | antagonist |
| Farnesyl pyrophosphate synthase | Humans | inhibitor |
ADME / PK
| Absorption | Oral bioavailability is 0.63% and maximum absorption is approximately 1 hour after dosing. Administration half and hour before a meal reduces bioavailability by 55% compared to fasting and dosing 1 hour before a meal reduces bioavailability by 30%. |
|---|---|
| Half-life | The initial half life of risedronic acid is approximately 1.5 hours, with a terminal half life of 561 hours. |
| Protein binding | ~24%. |
| Metabolism | Risedronic acid is not likely not metabolized before elimination. The P-C-P group of bisphosphonates is resistant to chemical and enzymatic hydrolysis preventing metabolism of the molecule. |
| Route of elimination | Risedronate is excreted by the kidneys and the unabsorbed dose is eliminated in the feces. |
| Volume of distribution | 13.8 L/kg. |
| Clearance | Mean renal clearance was 52mL/min and mean total clearance was 73mL/min. |
Formulation & handling
- Risedronic acid is formulated exclusively for oral administration, primarily as film-coated or effervescent tablets.
- This small molecule bisphosphonate exhibits high water solubility and requires administration on an empty stomach to optimize absorption.
- Handling precautions include avoiding co-administration with calcium, antacids, or other multivalent cations due to decreased bioavailability risk.
Regulatory status
| Lifecycle | The API is currently marketed in Canada and the United States with patent protections expiring between 2011 and 2023. As key patents have recently expired or are approaching expiration, the market is transitioning towards greater availability of generic alternatives. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for risedronic acid includes multiple originator companies involved in production and packaging, indicating a diversified supply chain. Branded products such as Actonel have a significant presence in North American markets, specifically the US and Canada. Patents with expiration dates extending into late 2023 suggest either recent or imminent availability of generic competition in these regions. |
|---|
Safety
| Toxicity | In clinical trials, over 10% of patients experienced back pain, arthralgia, abdominal pain, and dyspepsia. Less commonly, patients experience angioedema, generalized rash, bullous skin reactions, iritis, and uveitis. Patients experiencing an overdose may experience a decrease in serum calcium and phosphorus. Patients can be given milk or antacids to bind the drug and reduce its absorption. In more severe cases, patients may require gastric lavage and intravenous calcium. A lethal dose in rats is equivalent to 320 to 620 times the human dose based on surface area. |
|---|
- Exposure may cause musculoskeletal discomfort including back pain and arthralgia in over 10% of subjects
- Rare hypersensitivity reactions reported include angioedema, rash, and severe cutaneous adverse events
- Overdose potential includes hypocalcemia
Risedronate is a type of Bisphosphonates
Bisphosphonates are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the treatment of various bone-related conditions. These compounds play a crucial role in inhibiting bone resorption, making them particularly effective in managing diseases such as osteoporosis, Paget's disease, and bone metastasis associated with cancer.
The mechanism of action of bisphosphonates involves their binding to hydroxyapatite crystals in bone, leading to the suppression of osteoclast activity. By inhibiting the breakdown of bone tissue, these APIs help to maintain bone density and strength, thereby reducing the risk of fractures and improving overall bone health.
One of the key advantages of bisphosphonates is their high affinity for bone tissue, which allows for targeted treatment. They are administered orally or intravenously, depending on the specific formulation and indication. Commonly prescribed bisphosphonates include alendronate, ibandronate, and zoledronic acid, among others.
Bisphosphonates are generally well-tolerated, although some potential side effects, such as gastrointestinal disturbances or musculoskeletal pain, may occur. These APIs are metabolized in the liver and excreted through the kidneys.
Due to their effectiveness and widespread clinical use, bisphosphonates have gained significant attention in the pharmaceutical industry. Continuous research and development efforts are focused on improving their therapeutic profiles, including enhancing potency and reducing side effects.
In summary, bisphosphonates are a critical subcategory of pharmaceutical APIs employed in the management of bone-related disorders. Their targeted action on bone tissue and ability to inhibit bone resorption make them indispensable in the treatment of conditions like osteoporosis and bone metastasis. Ongoing advancements in this field are expected to further optimize their therapeutic benefits in the future.
Risedronate (Bisphosphonates), classified under Metabolic Bone Disease Agents
Metabolic Bone Disease Agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) that are specifically designed to treat and manage conditions related to the bones and their metabolism. These agents play a crucial role in the treatment of various metabolic bone diseases, including osteoporosis, Paget's disease, and rickets.
The primary function of Metabolic Bone Disease Agents is to regulate bone remodeling and maintain bone health. They achieve this by targeting specific pathways involved in bone metabolism, such as osteoclast and osteoblast activity, calcium regulation, and vitamin D metabolism.
These APIs are commonly used in the development of medications, including oral tablets, injectables, and topical formulations, for the effective treatment of metabolic bone diseases. They are carefully formulated to optimize their pharmacokinetic and pharmacodynamic properties, ensuring maximum efficacy and minimal side effects.
Metabolic Bone Disease Agents encompass a range of substances, including bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, and vitamin D analogs. These APIs act through different mechanisms to address specific aspects of bone health, such as inhibiting bone resorption, promoting bone formation, or regulating calcium levels.
In conclusion, Metabolic Bone Disease Agents are a vital category of pharmaceutical APIs used in the development of medications for the treatment and management of various metabolic bone diseases. These agents target specific pathways involved in bone metabolism to regulate bone remodeling, enhance bone health, and alleviate the symptoms associated with these conditions.
Risedronate API manufacturers & distributors
Compare qualified Risedronate API suppliers worldwide. We currently have 8 companies offering Risedronate API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Alchymars ICM SM | Producer | India | India | CoA, USDMF | 8 products |
| Cipla | Producer | India | Unknown | CEP, CoA, KDMF, USDMF, WC | 164 products |
| Hetero Drugs | Producer | India | India | CoA, GMP, USDMF, WC | 98 products |
| Ind-Swift Labs. | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC | 27 products |
| Ipca Labs. | Producer | India | India | CoA, GMP, USDMF, WC | 69 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Mylan | Producer | India | India | CEP, CoA, JDMF, USDMF, WC | 201 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
When sending a request, specify which Risedronate 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 Risedronate 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.
