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Suppliers and packagers for CLEOCIN HYDROCHLORIDE
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CLEOCIN HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | CLEOCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 050162 | NDA | Pharmacia & Upjohn Company LLC | 0009-0225-02 | 100 CAPSULE in 1 BOTTLE (0009-0225-02) | 1970-05-22 |
| Pfizer | CLEOCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 050162 | NDA | Pharmacia & Upjohn Company LLC | 0009-0331-02 | 100 CAPSULE in 1 BOTTLE (0009-0331-02) | 1970-05-22 |
| Pfizer | CLEOCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 050162 | NDA | Pharmacia & Upjohn Company LLC | 0009-0395-14 | 100 CAPSULE in 1 BOTTLE (0009-0395-14) | 1970-05-22 |
| Pfizer | CLEOCIN HYDROCHLORIDE | clindamycin hydrochloride | CAPSULE;ORAL | 050162 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-3328-1 | 100 CAPSULE in 1 BOTTLE (59762-3328-1) | 1970-05-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Cleocin Hydrochloride
Introduction
Cleocin Hydrochloride, with the generic name clindamycin hydrochloride, is a widely used antibiotic in the treatment of bacterial infections, including skin infections, respiratory tract infections, and anaerobic infections such as dental abscesses. Its efficacy, established safety profile, and broad spectrum of activity make it a staple in hospitals, clinics, and pharmacies worldwide. Analyzing the supply landscape reveals a robust network of manufacturers, importers, and distributors that ensure the availability of this essential medication across global markets. This report provides a comprehensive overview of key suppliers, their manufacturing capabilities, regulatory statuses, and market presence, providing insights to stakeholders involved in procurement, licensing, and competitive intelligence.
Overview of Clindamycin Hydrochloride Production
Clindamycin hydrochloride is a semi-synthetic antibiotic derived from lincomycin, originally isolated from Streptomyces lincolnensis. Its production involves complex fermentation and subsequent synthetic refinement. Several pharmaceutical companies possess the technology, API manufacturing capabilities, and regulatory approvals necessary to produce and distribute cleocin hydrochloride globally.
Major Suppliers of Cleocin Hydrochloride API
1. Pharmacia & Upjohn (Pfizer Inc.)
Pfizer, a prominent pharmaceutical leader, historically supplied high-quality clindamycin hydrochloride API, used both in branded and generic formulations. Although Pfizer's focus has shifted toward branded products, their manufacturing facilities in the United States and Europe maintain a portfolio capable of producing the API under strict regulatory compliance.
2. Sato Pharmaceutical Co., Ltd.
A dedicated API manufacturer based in Japan, Sato Pharmaceutical produces clindamycin hydrochloride API primarily for domestic use and exports throughout Asia. Their manufacturing process meets stringent quality standards, and they hold multiple regulatory approvals, including Japanese Pharmaceutical and Medical Device Act (PMDA) compliance.
3. Zhejiang Hisun Pharmaceutical Co., Ltd.
Located in China, Zhejiang Hisun is a leading generics manufacturer with extensive API production capacities. Their facility for clindamycin hydrochloride complies with Good Manufacturing Practice (GMP) standards, and they export to numerous markets, including North America, Europe, and Asia.
4. Zhejiang Jiuzhou Pharmaceutical Co., Ltd.
Another Chinese API producer, Jiuzhou Pharmaceutical has invested heavily in fermentation technology, producing clindamycin hydrochloride with high purity and consistent batch quality. They are licensed by multiple regulatory agencies, marking their competence in international markets.
5. Hubei Huida Pharmaceutical Co., Ltd.
Specializing in antibiotic APIs, this Chinese manufacturer supplies clindamycin hydrochloride to several generic drug makers, with certifications from the US FDA, EMA, and other national regulatory bodies.
Key API Suppliers in Europe and North America
6. Allergan (AbbVie)
Historically, Allergan was involved in the production of clindamycin hydrochloride, particularly for branded formulations. Post-divestment, AbbVie retains some manufacturing capabilities, which may supply select markets under licensing agreements.
7. Dr. Reddy's Laboratories
India-based manufacturer Dr. Reddy's supplies clindamycin hydrochloride API to global markets, emphasizing quality and cost-effectiveness. Their API production facilities are GMP-certified, and they export to North America, Europe, and Asia.
8. Aurobindo Pharma
Another Indian pharmaceutical company, Aurobindo produces clindamycin hydrochloride API, with a focus on markets requiring affordable generic antibiotics. Their manufacturing units meet international regulatory standards.
Contract Manufacturing and ODM Suppliers
Several pharmaceutical companies rely on contract manufacturing organizations (CMOs) for clindamycin hydrochloride API, leveraging their expertise, regulatory approvals, and scalable production capacities.
- Hetero Labs Ltd. (India): Provides contract manufacturing services for various antibiotics, including clindamycin hydrochloride.
- Jubilant Life Sciences (India): Offers API manufacturing with high-volume capacity and compliance with global regulatory standards.
Regulatory Considerations and Supply Chain Reliability
The stability of supply hinges on compliance with international GMP standards, regulatory approvals from agencies like the FDA, EMA, and PMDA, and capacity to meet global demand fluctuations. Manufacturers with robust regulatory track records are generally more reliable, reducing procurement risks.
Market Dynamics and Competitive Landscape
The primary markets for clindamycin hydrochloride include North America, Europe, and Asia-Pacific. The competitive landscape is characterized by a mix of established pharmaceutical giants and emerging regional manufacturers. Price competition, regulatory approvals, and quality assurance influence sourcing decisions for pharmaceutical companies and distributors.
Emerging Trends and Future Outlook
- Expansion of Chinese and Indian API manufacturing capacities aims to meet rising global demand for affordable antibiotics.
- Regulatory harmonization efforts facilitate easier market access for API producers holding multiple certifications.
- Advanced fermentation technology enhances purity and reduces production costs, supporting supply chain resilience amid global disruptions.
Key Blockades and Challenges
- Regulatory delays and compliance issues can hinder supply chain stability.
- Environmental and safety regulations in manufacturing regions may increase production costs.
- Trade tensions and import-export restrictions could temporarily impact API availability.
Conclusion
The supply of clindamycin hydrochloride API is consolidated among several reputable manufacturers globally, with Chinese and Indian firms dominating the market due to cost advantages and expanding capacities. Major multinational pharmaceutical companies retain critical manufacturing capabilities, although the landscape is increasingly competitive, especially for generic APIs. Ensuring supply chain resilience demands strategic sourcing from certified suppliers with proven regulatory compliance and high-quality standards. Opportunities lie in emerging markets and technologically advanced production facilities capable of scaling production to meet global demands efficiently.
Key Takeaways
- Major API suppliers for clindamycin hydrochloride include Pfizer, Zhejiang Hisun, Zhejiang Jiuzhou, and Indian firms like Dr. Reddy’s and Aurobindo.
- Chinese and Indian manufacturers dominate the API landscape, driven by expanding capacities and cost competitiveness.
- Regulatory compliance, GMP certification, and supply chain reliability are critical for sourcing clindamycin hydrochloride at scale.
- Contract manufacturing organizations serve as vital partners for API supply, offering flexibility and ensuring quality.
- Monitoring geopolitical and regulatory shifts is essential to mitigate supply disruptions.
FAQs
1. Who are the leading global suppliers of clindamycin hydrochloride API?
Leading suppliers include Zhejiang Hisun Pharmaceutical, Zhejiang Jiuzhou Pharmaceutical, Dr. Reddy’s Laboratories, and Aurobindo Pharma, among others, with major capacities in China and India.
2. What regulatory certifications should reliable clindamycin hydrochloride API suppliers possess?
Suppliers should hold GMP certification, and approval from major agencies such as the FDA, EMA, or PMDA, ensuring quality and compliance for international distribution.
3. Are there regional differences in clindamycin hydrochloride API manufacturing?
Yes, Chinese and Indian manufacturers dominate supply due to large-scale production and cost advantages, while US and European companies focus on high-regulatory compliance markets.
4. How can pharmaceutical companies mitigate risks in clindamycin hydrochloride API supply chains?
Biomanufacturers can diversify suppliers, establish long-term contracts with certified manufacturers, and monitor regulatory changes that could impact production.
5. What future developments could affect clindamycin hydrochloride API supply?
Emerging technologies, increased capacity, regulatory harmonization, and geopolitical factors are expected to influence supply dynamics in the coming years.
Sources
- Pfizer Inc. Annual Reports and Product Portfolio.
- Sato Pharmaceutical Co., Ltd. Official Website.
- Zhejiang Hisun Pharmaceutical Co., Ltd. Corporate Reports.
- Zhejiang Jiuzhou Pharmaceutical Co., Ltd. Regulatory Filings.
- Indian Pharmaceutical Gazette, Aurobindo Pharma and Dr. Reddy’s documentation.
- WHO List of Essential Medicines and API manufacturers documentation.
- Industry analyst reports on antibiotic API markets (2022-2023).
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