- Raw materials
- Hormonal Agents
- Progestagens
- Medroxyprogesterone acetate
Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Medroxyprogesterone 17-acetate (Medroxyprogesterone acetate) API Manufacturers & Suppliers
16 verified results
All Medroxyprogesterone acetate data. Full access. Full negotiation power
Commercial-scale Suppliers
Employees: 200+
All certificates
All certificates
Employees: 200+
All certificates
Employees: 50+
All certificates
All certificates
Employees: 3,500+
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Medroxyprogesterone acetate | CAS No: 71-58-9 | GMP-certified suppliers
A medication that addresses menstrual disorders, supports endometrial protection and menopausal symptom management, provides long‑acting contraception, and aids care in endometriosis and select cancers.
Therapeutic categories
Primary indications
- Medroxyprogesterone acetate (MPA) oral tablets are indicated to treat secondary amenorrhea, reduce the incidence of endometrial hyperplasia in postmenopausal women, and to treat abnormal uterine bleeding due to hormonal imbalance, not organic pathology
- Oral tablets containing MPA and conjugated estrogens are indicated to prevent postmenopausal osteoporosis and to treat moderate to severe menopausal symptoms such as vasomotor symptoms, vulvar atrophy, and vaginal atrophy
- Subcutaneous MPA is indicated to prevent pregnancy and manage pain associated with endometriosis
- Intramuscular MPA is indicated to prevent pregnancy,and at higher concentrations for palliative treatment of endometrial or renal carcinoma
Product Snapshot
- Medroxyprogesterone acetate is available as an oral small‑molecule tablet and as parenteral injectable suspensions for intramuscular or subcutaneous use
- It is used in hormone‑related gynecologic conditions, menopausal symptom management, contraception, and as palliative therapy in certain cancers
- It is approved in the US and Canada, with some formulations also noted as investigational
Clinical Overview
Pharmacologically, the compound is a progesterone derivative with enhanced metabolic stability, contributing to prolonged activity. It suppresses gonadotropin secretion, inhibiting follicular maturation and ovulation, while promoting endometrial thinning. In endometrial tissue, it reduces nuclear estrogen receptors and limits DNA synthesis in epithelial cells. Medroxyprogesterone acetate also induces p53‑dependent apoptosis in certain cancer cell lines and has been reported to inhibit GABA‑A receptor activity.
Key pharmacokinetic features include an oral half‑life of approximately 40 to 60 hours, with substantially longer persistence for depot formulations. The therapeutic window is broad, with clinical dosing ranging from low‑dose daily oral administration to high‑dose weekly intramuscular injections. The compound undergoes hepatic metabolism and is eliminated partly via the kidneys.
Safety considerations include reduced bone mineral density with long‑term use, especially when exposure occurs during adolescence, potentially affecting peak bone mass and future fracture risk. Additional risks vary by formulation and dose, particularly in populations receiving high‑dose regimens for oncology indications.
For API procurement, suppliers should provide robust evidence of stereochemical integrity, impurity control aligned with pharmacopeial expectations, and manufacturing processes capable of supporting consistent particle‑size distribution suitable for oral and parenteral drug product development.
Identification & chemistry
| Generic name | Medroxyprogesterone acetate |
|---|---|
| Molecule type | Small molecule |
| CAS | 71-58-9 |
| UNII | C2QI4IOI2G |
| DrugBank ID | DB00603 |
Pharmacology
| Summary | Medroxyprogesterone acetate acts primarily as a progestin that suppresses gonadotropin release, inhibiting follicular maturation and ovulation while inducing endometrial thinning. Its activity includes modulation of progesterone and estrogen receptors and reduced epithelial DNA synthesis, with additional context‑dependent effects such as p53‑dependent apoptosis in certain cancer cell lines and inhibition of GABA‑A receptors. These mechanisms support its use in hormonal regulation, contraception, and selected oncologic settings. |
|---|---|
| Mechanism of action | Medroxyprogesterone acetate (MPA) inhibits the production of gonadotropin, preventing follicular maturation and ovulation, which is responsible for it’s ability to prevent pregnancy.This action also thins the endometrium.MPA reduces nuclear estrogen receptors and DNA synthesis in epithelial cells of the endometrium.MPA can also induce p53 dependant apoptosis in certain cancer cell lines,and inhibit GABA-A receptors. |
| Pharmacodynamics | Medroxyprogesterone acetate (MPA) inhibits gonadotropin production, reduces nuclear estrogen receptors and DNA synthesis in epithelial cells of the endometrium, and induces p53 dependant apoptosis in cancer cell lines.MPA oral tablets have a half life of 40-60 hours and other formulations can have half lives that are considerably longer, so the duration of action is long.The therapeutic window is wide as patients may take doses ranging from 5mg orally daily to 1000mg as a depo injection weekly.Long term use of MPA is associated with a reduction in bone density and patients who taking MPA during adolescence may have lower peak bone mass than untreated patients, which can also increase the risk of osteoporosis and fractures in the future. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Progesterone receptor | Humans | agonist |
| Estrogen receptor alpha | Humans | agonist |
| P-glycoprotein 1 | Humans | inhibitor |
ADME / PK
| Absorption | Absorption of oral medroxyprogesterone acetate (MPA) varies considerably between formulations.A 1000mg oral dose reaches an average C<sub>max</sub> of 145-315nmol/L while a 500mg oral dose reaches an average C<sub>max</sub> of 33-178nmol/L with a T<sub>max</sub> of 1-3 hours and a lag time of half an hour.The AUC of a 500mg oral dose of MPA was 543.4-1981.1nmol\*L/h depending on formulation. Intramuscular MPA reaches a C<sub>max</sub> of 4.69±1.52nmol/L with a T<sub>max</sub> of 4.75±2.09 days and an AUC of 81.58±27.64days\*nmol/L.Subcutaneous MPA reaches a C<sub>max</sub> of 3.83±1.56nmol/L with a T±max of 6.52±2.07 days and an AUC of 72.26±38.73days\*nmol/L.However, the pharmacokinetics of MPA may also vary depending on injection site. |
|---|---|
| Half-life | Oral medroxyprogesterone acetate (MPA) has an absorption half life of 15-30min and a biological half life of 40-60 hours.Intramuscular MPA has an absorption half life of 0.86±0.30 days and an elimination half life of 24.03±21.74 days.Subcutaneous MPA has an absorption half life of 1.05±0.56 days and an elimination half life of 30.90±15.11 days. |
| Protein binding | Medroxyprogesterone acetate is 86% protein bound in serum, mainly to albumin.No binding occurs with sex hormone binding globulin. |
| Metabolism | Medroxyprogesterone acetate undergoes beta hydroxylation to form the metabolites 6-beta (M-2), 2-beta (M-4), and 1-beta-hydroxymedroxyprogesterone acetate (M-3).M-2 and M-4 are further metabolized to 2-beta,6-beta-dihydroxymedroxyprogesterone (M-1).M-3 is further metabolized to 1,2-dehydromedroxyprogesterone acetate (M-5). |
| Route of elimination | The majority of medroxyprogesterone acetate (MPA) is eliminated in the urine as glucuronide conjugates and a minority of sulphate conjugates.Glucuronide conjugates are also detected in the feces.Determining the exact ratio of metabolites and parent compound eliminated in the urine and feces is difficult as the metabolite profile in the urine is not significantly differentand radio labelling studies are not readily available. |
| Volume of distribution | The volume of distribution of medroxyprogesterone acetate is 20±3L. |
| Clearance | The mean clearance of medroxyprogesterone acetate (MPA) is 1668±146L/day or 21.9±4.3L/kg/day.Due to the high inter patient variability in MPA pharmacokinetics, clearance has been reported to be 1600-4000L/day. |
Formulation & handling
- Oral formulations may require solubility‑enhancing approaches due to very low aqueous solubility and food‑dependent increases in bioavailability.
- Parenteral products are typically long‑acting intramuscular or subcutaneous suspensions, with particle size and suspension stability being key for consistent release.
- Hydrophobic steroidal solid requires careful control of crystallinity and milling during handling to ensure uniformity in tablets and injectable suspensions.
Regulatory status
| Lifecycle | Patent protection in the United States and Canada expired between 2020 and 2021, indicating that the API is now fully exposed to generic competition. With products marketed in both countries, the asset is in a mature, post‑exclusivity phase. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Medroxyprogesterone acetate has long‑established originator roots, with legacy Pharmacia/Upjohn products (now under Pfizer) forming the basis for branded formulations such as Depo‑Provera. The product is widely available in the US and Canada, supported by extensive generic manufacturing and repackaging activity. Patent expiries in the US (2020) and Canada (2021) indicate that generics are already well established in these markets. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> in rats is >6400mg/kg and in mice is >16g/kg.The intraperitoneal LD<sub>50</sub> in rats is >900mg/kg and in mice is >1500mg/kg.The subcutaneous LD<sub>50</sub> in rats is >900mg/kg and in mice is>1500mg/kg. Patients experiencing and overdose or oral medroxyprogesterone acetate (MPA) may present with nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness, fatigue, and withdrawal bleeding.Treat patients by stopping MPA and beginning symptomatic treatment.Patients who have been given too much of a MPA depo injection should contact a healthcare professional, hospital emergency department, or local poison control immediately. |
|---|
- High acute toxicity thresholds: reported oral LD50 values exceed 6400 mg/kg in rats and 16 g/kg in mice
- Intraperitoneal and subcutaneous LD50 values are above 900 mg/kg in rats and 1500 mg/kg in mice
- Overexposure has been associated with CNS and gastrointestinal effects, including drowsiness, dizziness, nausea, and abdominal discomfort, indicating the need for controls that limit excessive systemic exposure during handling
Medroxyprogesterone acetate is a type of Progestagens
Progestagens are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in hormonal therapies and contraceptives. Also known as progestins, these synthetic compounds mimic the effects of the naturally occurring hormone progesterone in the body.
Progestagens are widely used in various medical applications due to their ability to regulate the menstrual cycle, support pregnancy, and prevent undesired conception. They function by binding to progesterone receptors and modulating the reproductive system's activity.
In addition to their contraceptive properties, progestagens are utilized in hormone replacement therapy (HRT) to alleviate symptoms associated with menopause, such as hot flashes and mood swings. They can also be prescribed to treat irregular menstruation, endometriosis, and certain types of cancer, including breast and uterine cancers.
Pharmaceutical companies develop progestagens in different formulations, including oral tablets, injections, and implants, to cater to diverse patient needs. These formulations offer varying durations of action, allowing healthcare professionals to tailor treatment regimens to individual patients.
While progestagens are generally well-tolerated, they may be associated with certain side effects, such as weight gain, bloating, and breast tenderness. It is essential for healthcare providers to assess patient medical history and monitor their response to progestagen therapy closely.
In conclusion, progestagens are a vital class of pharmaceutical APIs with significant therapeutic applications. Their versatility and effectiveness in hormonal regulation make them a cornerstone of various hormonal therapies, providing patients with safe and reliable options for contraception, HRT, and managing reproductive disorders.
Medroxyprogesterone acetate (Progestagens), classified under Hormonal Agents
Hormonal agents are a prominent category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These substances play a crucial role in regulating and modulating hormonal functions within the body. Hormonal agents are designed to mimic or manipulate the effects of naturally occurring hormones, allowing healthcare professionals to treat various endocrine disorders and hormonal imbalances.
Hormonal agents are commonly employed in the treatment of conditions such as hypothyroidism, hyperthyroidism, diabetes, and hormonal cancers. These APIs work by interacting with specific hormone receptors, either by stimulating or inhibiting their activity, to restore the balance of hormones in the body. They can be administered orally, intravenously, or through other routes depending on the specific medication and patient needs.
Pharmaceutical companies employ rigorous manufacturing processes and quality control measures to ensure the purity, potency, and safety of hormonal agent APIs. These APIs are synthesized using chemical or biotechnological methods, often starting from natural hormone sources or through recombinant DNA technology. Stringent regulatory guidelines are in place to guarantee the efficacy and safety of hormonal agent APIs, ensuring that patients receive high-quality medications.
As the demand for hormone-related therapies continues to grow, ongoing research and development efforts focus on enhancing the effectiveness and reducing the side effects of hormonal agent APIs. This includes the exploration of novel delivery systems, advanced formulations, and targeted drug delivery methods. By continuously advancing our understanding and capabilities in hormonal agents, the medical community can improve patient outcomes and quality of life for individuals with hormonal disorders.
Medroxyprogesterone acetate API manufacturers & distributors
Compare qualified Medroxyprogesterone acetate API suppliers worldwide. We currently have 16 companies offering Medroxyprogesterone acetate API, with manufacturing taking place in 8 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 |
|---|---|---|---|---|---|
| AMARI TRADE ALLIANEC LLP | Distributor | India | India | CoA | 15 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CoA, GMP, MSDS | 176 products |
| Bayer | Producer | Germany | Unknown | CEP, CoA, GMP, KDMF, USDMF | 42 products |
| Cambrex | Producer | Italy | United States | CoA, GMP | 104 products |
| Coral Drugs | Producer | India | India | BSE/TSE, CoA, FDA, GMP, WC, WHO-GMP | 25 products |
| Curia | Producer | United States | Spain | CoA, GMP, MSDS, USDMF | 106 products |
| Farmabios | Producer | Italy | Italy | CEP, CoA, FDA, GMP, ISO9001, JDMF, KDMF, USDMF | 58 products |
| Jiangsu Jiaerke | Producer | China | China | CoA | 11 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| Pharmacia & Upjohn | Producer | United States | United States | CoA, USDMF | 30 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sicor De México | Producer | Mexico | Mexico | CEP, CoA, FDA, KDMF | 11 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 762 products |
| Yuayang Huanyu | Producer | China | China | CoA, WC | 1 products |
| Yueyang Huanyu | Producer | China | China | CoA, WC | 1 products |
| Zhejiang Xianju | Producer | China | China | CoA, USDMF | 17 products |
When sending a request, specify which Medroxyprogesterone acetate 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 Medroxyprogesterone acetate 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 Medroxyprogesterone acetate API
Sourcing
What matters most when sourcing GMP-grade Medroxyprogesterone acetate?
Which documents are typically required when sourcing Medroxyprogesterone acetate API?
Which manufacturers are known to produce Medroxyprogesterone acetate API?
How can I request quotes for Medroxyprogesterone acetate API from GMP suppliers?
Is a GMP audit report available for Medroxyprogesterone acetate manufacturers?
How many suppliers offer Medroxyprogesterone acetate API on Pharmaoffer?
Which countries are known to manufacture Medroxyprogesterone acetate API?
Which certifications do suppliers of Medroxyprogesterone acetate usually hold?
Technical
What is Medroxyprogesterone acetate (CAS 71-58-9) used for?
Which therapeutic class does Medroxyprogesterone acetate fall into?
What conditions is Medroxyprogesterone acetate mainly prescribed for?
How does Medroxyprogesterone acetate work?
What should someone know about the safety or toxicity profile of Medroxyprogesterone acetate?
What are important formulation and handling considerations for Medroxyprogesterone acetate as an API?
Is Medroxyprogesterone acetate a small molecule?
Are there special stability concerns for oral Medroxyprogesterone acetate?
Regulatory
Where is Medroxyprogesterone acetate approved or in use globally?
What’s the regulatory and patent landscape for Medroxyprogesterone acetate right now?
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Medroxyprogesterone acetate procurement?
Is Medroxyprogesterone acetate included in the PRO Data Insights coverage?
Where can I access the API market report for Medroxyprogesterone acetate?
