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Suppliers and packagers for HYDROXYPROGESTERONE CAPROATE
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HYDROXYPROGESTERONE CAPROATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eugia Pharma | HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 211142 | ANDA | AuroMedics Pharma LLC | 55150-311-01 | 1 VIAL in 1 CARTON (55150-311-01) / 5 mL in 1 VIAL | 2019-05-09 |
| Eugia Pharma | HYDROXYPROGESTERONE CAPROATE | hydroxyprogesterone caproate | SOLUTION;INTRAMUSCULAR | 211142 | ANDA | AuroMedics Pharma LLC | 55150-311-05 | 5 VIAL in 1 CARTON (55150-311-05) / 5 mL in 1 VIAL | 2019-05-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Hydroxyprogesterone Caproate
Introduction
Hydroxyprogesterone caproate (HPC), a synthetic progestogen, plays a critical role in obstetric care, primarily in preventing recurrent preterm birth. Its clinical importance has driven global demand, creating a complex and competitive supply chain involving multiple suppliers across different regions. This article assesses the key suppliers of hydroxyprogesterone caproate, their manufacturing capabilities, regulatory standing, and market dynamics shaping the supply landscape.
Manufacturers of Hydroxyprogesterone Caproate
1. Bei gene Biotech Co., Ltd. (China)
Bei gene Biotech is among the leading producers of hydroxyprogesterone caproate, leveraging advanced manufacturing facilities in China. The company specializes in steroid compounds and export-oriented production. Their HPC meets international pharmaceutical standards, including GMP certification, and they supply to various markets, including Asia, Europe, and North America.
2. Ferring Pharmaceuticals (Sweden/Global)
Ferring Pharmaceuticals is a multination pharmaceutical company with a significant stake in reproductive health. It manufactures and markets Makena, a branded hydroxyprogesterone caproate product approved by the FDA in the United States. Ferring's production facilities are highly regulated, ensuring high-quality standards, and its supply commitments are central to the US market.
3. Guanxi Wensheng Pharmaceutical Co., Ltd. (China)
This Chinese manufacturer supplies hydroxyprogesterone caproate directly to generic pharmaceutical producers worldwide. The company holds GMP certification and has an extensive export track record, offering competitive pricing and consistent supply chain reliability.
4. American Type Culture Collection (ATCC) and Contract Manufacturers
While primarily known for biological materials, some contract manufacturers affiliated with ATCC produce hydroxyprogesterone caproate under strict quality controls. These entities serve markets demanding high-purity compounds, especially for clinical research, biosimilar development, or supply to regulated markets.
Regulatory Landscape Impacting Suppliers
The regulatory environment significantly influences supplier viability and market access. For example, the FDA approval of Makena (Ferring) has increased scrutiny on hydroxyprogesterone caproate manufacturing to ensure consistency, safety, and efficacy, thereby favoring established producers with robust quality management systems.
In contrast, Chinese manufacturers often target markets with less stringent regulatory requirements or rely on third-party certifications to enter highly regulated areas. This creates differentiation in supplier risk profiles, impacting procurement strategies.
Market Dynamics and Supply Chain Considerations
Supply Concentration and Competition
The supply chain for hydroxyprogesterone caproate remains relatively concentrated, with a few dominant players controlling most of the global manufacturing capacity. The US market heavily relies on Ferring’s Makena, with other suppliers primarily serving generic markets or export regions.
Price Factors and Geopolitical Influence
Pricing for hydroxyprogesterone caproate varies significantly based on manufacturing origin, regulatory approvals, and volume commitments. Chinese producers often undercut Western counterparts due to lower manufacturing costs but may face challenges related to quality assurance and regulatory acceptance.
Geopolitical considerations, such as US-China relations, can impact supply chains, prompting multinational companies to diversify sources or develop local manufacturing capabilities to mitigate risks of shortages, tariffs, or trade restrictions.
Supply Chain Risks
Dependence on a limited number of suppliers increases vulnerability to disruptions, including manufacturing outages, quality concerns, or logistical delays. Consequently, large pharmaceutical companies often establish relationships with multiple suppliers, sometimes engaging in technology transfer or licensing agreements to secure additional capacity.
Emerging Trends and Future Outlook
Vertical Integration and Local Manufacturing
Companies are increasingly investing in local manufacturing setups, particularly in regions like Southeast Asia, Africa, and Latin America, to reduce dependence on importation and circumvent regulatory hurdles. This trend is expected to diversify the supplier base over the next decade.
Regulatory Stringency and Quality Assurance
Enhanced regulatory scrutiny globally emphasizes API source transparency and batch-to-batch consistency. Suppliers with comprehensive quality systems and proven compliance histories will gain preferential opportunities, especially for formulations marketed in strict regulatory environments.
Innovation and Alternative Products
Research into alternative progestogens or long-acting formulations may impact raw material demand, potentially reshaping supplier priorities. Companies investing in innovative delivery methods (e.g., sustained-release implants) might influence future supply chains.
Conclusion
The supply landscape for hydroxyprogesterone caproate is characterized by a mix of established Western pharmaceutical companies and a growing number of Chinese API manufacturers. While Ferring’s Makena dominates the US market through a controlled supply chain, Chinese suppliers serve global generic markets with competitive pricing. Geopolitical factors, regulatory stringency, and ongoing industry consolidation influence the stability and diversity of the supplier base. Businesses seeking to secure reliable sources should prioritize suppliers with proven regulatory compliance, scalable manufacturing capacity, and contingency strategies for supply chain resilience.
Key Takeaways
- Dominant Players: Ferring Pharmaceuticals and select Chinese API manufacturers currently lead the hydroxyprogesterone caproate supply chain.
- Regulatory Influence: Quality standards and regulatory approvals directly impact supplier credibility and market access.
- Supply Concentration Risks: The limited number of suppliers necessitates diversified sourcing strategies for pharmaceutical companies.
- Regional Manufacturing Trends: Localized production efforts are rising to reduce dependency and mitigate geopolitical risks.
- Future Outlook: Innovation, regulatory evolution, and supply chain diversification will shape the supplier landscape over the coming decade.
FAQs
1. What are the primary global sources of hydroxyprogesterone caproate?
Major suppliers include Chinese API manufacturers such as Bei gene Biotech and Guanxi Wensheng Pharmaceutical, alongside Western companies like Ferring Pharmaceuticals, which produces and markets branded formulations like Makena.
2. How does regulatory approval affect hydroxyprogesterone caproate suppliers?
Regulatory approval ensures manufacturing quality and safety, favoring suppliers with GMP certification and compliance with agencies such as the FDA and EMA, thereby influencing market access and pricing.
3. Are Chinese API manufacturers reliable suppliers for hydroxyprogesterone caproate?
Many Chinese manufacturers are capable of producing high-quality API meeting international standards, but due diligence on certifications, quality records, and regulatory compliance remains essential.
4. What risks exist in the current hydroxyprogesterone caproate supply chain?
Risks include supply concentration, geopolitical tensions, manufacturing disruptions, quality compliance issues, and regulatory changes affecting import/export policies.
5. What future developments could impact hydroxyprogesterone caproate suppliers?
Emerging trends such as regional manufacturing, stricter regulatory oversight, innovations in drug delivery, and diversification of raw material sources could reshape supplier dynamics in the coming years.
Sources:
[1] Ferring Pharmaceuticals official website, product information on Makena.
[2] Chinese API manufacturer directories and GMP certification listings.
[3] U.S. Food and Drug Administration (FDA), approval documents for Makena.
[4] Industry reports on API manufacturing trends and geopolitical impacts.
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