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Suppliers and packagers for generic pharmaceutical drug: PROCARBAZINE HYDROCHLORIDE
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PROCARBAZINE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Leadiant Biosci Inc | MATULANE | procarbazine hydrochloride | CAPSULE;ORAL | 016785 | NDA | Leadiant Biosciences, Inc. | 54482-054-01 | 100 CAPSULE in 1 BOTTLE (54482-054-01) | 1985-12-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Procarbazine Hydrochloride
Introduction
Procarbazine hydrochloride is an alkylating agent primarily used in chemotherapy protocols, notably for Hodgkin's lymphoma and certain brain tumors. Its efficacy and safety profile depend significantly on reliable sourcing from qualified suppliers. This article provides an in-depth analysis of primary suppliers manufacturing or distributing procarbazine hydrochloride, highlighting their regulatory standings, manufacturing capacities, and market presence. Understanding supplier landscapes equips pharmaceutical and biotech companies, healthcare providers, and research institutions to strategize procurement and regulatory compliance effectively.
Overview of Procarbazine Hydrochloride
Procarbazine hydrochloride (chemical formula: C_12H_17N_3O·HCl) is a methylhydrazine derivative with potent alkylating activity. Its historical importance in chemotherapeutic regimens underscores the necessity for high-quality production standards. Suppliers must adhere to Good Manufacturing Practices (GMP) to meet regulatory approvals across different jurisdictions.
Major Suppliers and Manufacturers
1. Sigma-Aldrich (Part of Merck KGaA)
Overview: Sigma-Aldrich, a leading global supplier of laboratory chemicals, offers pharmaceutical-grade procarbazine hydrochloride for research applications. Although primarily focused on research chemicals, their products often serve as intermediates in pharmaceutical manufacturing.
Regulatory Compliance: Their compounds comply with ISO standards and are suitable for clinical research use, but additional regulatory approvals are required for pharmaceutical production.
Market Position: Sigma-Aldrich's extensive distribution network ensures worldwide availability, with laboratories across the globe relying on their consistent quality.
2. Target Molecule Corporation
Overview: Target Molecule specializes in rare and cytotoxic APIs, including procarbazine hydrochloride. Their focus on niche oncology drugs positions them as a strategic supplier for pharmaceutical manufacturers.
Manufacturing Capacity: They maintain dedicated facilities compliant with EPA and FDA GMP standards for cytotoxic agents, ensuring quality and safety.
Market Presence: Their clientele comprises multinational pharmaceutical companies and research institutions operating in North America and Europe.
3. Chengdu Pufeide Pharmaceutical Co., Ltd.
Overview: This Chinese pharmaceutical manufacturer produces raw APIs, including procarbazine hydrochloride, primarily for export markets. They offer competitive pricing but may require rigorous quality verification due to varying international regulatory standards.
Regulatory Status: Their products are often used in Asian markets; however, for global pharmaceutical applications, certification via initiatives like ISO 9001 and Good Manufacturing Practice (GMP) accreditation are crucial.
Supply Reliability: The firm's manufacturing capacity has expanded over recent years, with certifications allowing wider distribution.
4. Spectrum Chemical Manufacturing Corp.
Overview: Spectrum Chemical supplies a range of chemicals including procarbazine hydrochloride, primarily for research and laboratory use.
Regulatory and Quality Standards: Their products meet USP, EP, or JP standards, suitable for research purposes but not necessarily for human pharmaceutical manufacturing.
Distribution: Globally accessible, with robust logistics support.
5. Suppliers Via Contract Manufacturing Organizations (CMOs)
Overview: Several CMOs worldwide can manufacture procarbazine hydrochloride under client specifications. Engaging CMOs allows pharmaceutical companies to outsource API production, ensuring capacity scalability and regulatory compliance.
Key Players: Divisions of global CMOs such as WuXi STA, Evonik Industries, and Patheon offer API manufacturing services, including cytotoxic compounds.
Regulatory and Quality Considerations
Suppliers must comply with regional regulatory standards—FDA (US), EMA (Europe), PMDA (Japan)—plus international GMP guidelines. For therapeutic use, the API must meet strict purity criteria, with certificates of analysis (CoA) and batch records rigorously maintained. Due diligence is necessary when selecting suppliers, emphasizing regulatory documentation, quality certifications, and production capacity.
Emerging Trends Impacting Suppliers
- Increasing Demand for GMP-certified APIs: Global health authorities enforce stringent quality controls, prompting suppliers to upgrade facilities.
- Geographical Diversification: Companies seek diversified sources to mitigate supply chain risks, especially amid geopolitical tensions or pandemic-induced disruptions.
- Rise in Contract Manufacturing: The shift toward outsourcing API manufacturing to specialized CMOs enhances supply-chain resilience and compliance.
Market Challenges
- Regulatory Barriers: Variations in regional regulations can complicate procurement.
- Limited Suppliers: Given its specialized use, only a few manufacturers produce high-quality, GMP-compliant procarbazine hydrochloride.
- Pricing and Availability: The niche nature of the API influences pricing dynamics and inventory levels.
Conclusion
The supply landscape for procarbazine hydrochloride includes a mixture of established pharmaceutical giants, research chemical suppliers, and specialized contract manufacturers. Strategic sourcing requires balancing quality, regulatory compliance, supply reliability, and cost. While global corporations such as Sigma-Aldrich and targeted OEMs dominate the market, regional manufacturers, especially in Asia, are extending their reach. Companies must conduct thorough due diligence to ensure sourcing aligns with pharmaceutical standards, enabling uninterrupted access for clinical and commercial applications.
Key Takeaways
- The primary suppliers of GMP-grade procarbazine hydrochloride include Sigma-Aldrich, Target Molecule Corporation, Chengdu Pufeide Pharmaceutical, and Spectrum Chemical.
- Engaging trusted manufacturers with comprehensive regulatory certifications is critical for pharmaceutical applications.
- The API market for procarbazine hydrochloride remains niche, demanding strategic procurement planning to address supply chain risks.
- Increasing reliance on contract manufacturing organizations enhances flexibility and compliance but requires rigorous supplier evaluation.
- Geographic diversification of suppliers can mitigate regional risks and ensure stable supplies for clinical and commercial needs.
FAQs
1. Is procarbazine hydrochloride available from major global chemical suppliers?
Yes. Major suppliers like Sigma-Aldrich and Spectrum provide research-grade procarbazine hydrochloride, while specialized manufacturers and CMOs supply GMP-grade API for pharmaceutical use.
2. What should be considered when sourcing procarbazine hydrochloride for clinical use?
Regulatory compliance (GMP certification), purity levels (typically >99%), batch consistency, and comprehensive quality documentation are essential.
3. Are there regional differences in suppliers for procarbazine hydrochloride?
Yes. North American and European markets mainly source from Western suppliers, while Asia has several competitively priced manufacturers, particularly in China and India.
4. How does the regulatory status affect procurement of procarbazine hydrochloride?
Regulatory approvals, such as FDA or EMA registration, influence supplier credibility and API quality, impacting clinical and commercial application.
5. Can I convert research-grade procarbazine hydrochloride to pharmaceutical-grade?
Conversion requires rigorous purification, validation, and regulatory approval. It's recommended to source directly from GMP-certified suppliers for pharmaceutical applications.
References
[1] ChemSpider. Procarbazine Hydrochloride: Chemical Data.
[2] Sigma-Aldrich. Product Information for Procarbazine Hydrochloride.
[3] Target Molecule Corporation. API Portfolio.
[4] GMP Compliance Standards. U.S. FDA.
[5] Contract Manufacturing and API Sourcing Trends. Pharmaceutical Technology.
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