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Suppliers and packagers for generic pharmaceutical drug: hydroxocobalamin
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hydroxocobalamin
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Btg Intl | CYANOKIT | hydroxocobalamin | INJECTABLE;INJECTION | 022041 | NDA | BTG INTERNATIONAL INC. | 50633-310-11 | 1 VIAL, GLASS in 1 CARTON (50633-310-11) / 250 mL in 1 VIAL, GLASS | 2021-12-15 |
| Actavis | HYDROXOCOBALAMIN | hydroxocobalamin | INJECTABLE;INJECTION | 085998 | ANDA | Actavis Pharma, Inc. | 0591-2888-30 | 1 VIAL, MULTI-DOSE in 1 CARTON (0591-2888-30) / 30 mL in 1 VIAL, MULTI-DOSE | 2010-11-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Hydroxycobalamin
Introduction
Hydroxycobalamin, a form of vitamin B12, is a critical pharmaceutical agent used primarily in the treatment of vitamin B12 deficiency and cyanide poisoning. Its application in clinical settings and the rising global demand highlight the importance of a reliable supply chain. This article examines the leading suppliers of hydroxycobalamin, its manufacturing landscape, and factors influencing its sourcing options for pharmaceutical companies and healthcare providers.
Manufacturing Landscape of Hydroxycobalamin
Hydroxycobalamin is produced through complex biological and chemical synthesis processes, often involving fermentation or extraction methods utilizing microorganisms like Propionibacterium shermanii or Pseudomonas denitrificans. The manufacturing process demands high purity standards, with stringent quality controls to meet regulatory requirements set forth by agencies such as the FDA and EMA.
Major pharmaceutical producers typically operate across Europe, Asia, and North America, leveraging advanced biotechnological platforms. The supply chain's robustness depends heavily on sourcing raw materials like cobalt salts and maintaining validated production facilities.
Leading Suppliers of Hydroxycobalamin
1. Merck KGaA (Germany)
Merck, a globally recognized pharmaceutical and chemical company, is among the leading suppliers of cyanocobalamin and hydroxycobalamin. Their production facilities for injectable vitamin B12 derivatives adhere to high-quality standards, with supply chains supported by global distribution networks. Merck's hydroxycobalamin products are employed in clinical practices worldwide, especially in Europe and North America.
2. ELCOS Pharma (India)
ELCOS Pharma specializes in the manufacturing of vitamin B12 derivatives, including hydroxycobalamin. Based in India, ELCOS has expanded its footprint across Asia and Africa, offering cost-effective solutions for bulk procurement. The company's facilities are approved by international regulatory authorities, and they supply both bulk API and finished formulations.
3. Fermentek Ltd. (Israel)
Fermentek focuses on the biosynthesis of various bioactive compounds, including hydroxycobalamin, through fermentation technologies. Their emphasis on precision manufacturing and high purity standards makes them a sought-after supplier in research and clinical settings. Fermentek's products are recognized for their high quality, aligning with pharmaceutical industry needs.
4. Tianjin, Tianyao Pharmaceutical Co., Ltd. (China)
Tianjin-based Tianyao Pharmaceutical offers API production, including hydroxycobalamin, emphasizing competitive pricing and scalable manufacturing capabilities. Their facilities operate under strict GMP protocols, with exports concentrated in Asia and emerging markets.
5. Shanghai Pharma (China)
Shanghai Pharma supplies pharmaceutical raw materials and APIs including vitamin B12 derivatives like hydroxycobalamin. Their extensive distribution channels and adherence to international standards position them as significant players, particularly in Asia-Pacific regions.
Emerging and Regional Suppliers
Apart from these leading entities, several regional producers in Eastern Europe and Southeast Asia serve local markets, often providing cost-effective alternatives. These include smaller-scale manufacturers with capacities scaled to regional needs, often seeking international quality certifications to expand their export potential.
Factors Influencing Supplier Selection
Regulatory Compliance
Ensuring supplied hydroxycobalamin meets international standards (e.g., USP, Ph. Eur., JP) is critical. Suppliers with robust regulatory compliance facilitate smoother procurement and reduce the risk of supply disruptions.
Quality Assurance
High purity and consistent batch-to-batch quality are essential to maintain clinical efficacy. Suppliers with comprehensive quality management systems and transparency in manufacturing processes are preferred.
Pricing and Supply Security
Cost competitiveness influences procurement decisions, especially in large-volume markets. Additionally, suppliers capable of sustaining supply chains during global disruptions (e.g., pandemics, geopolitical issues) are highly valued.
Geographical Considerations
Proximity to manufacturing facilities can reduce lead times and shipping costs, making regional suppliers more attractive in certain contexts.
Supply Chain Challenges and Opportunities
The supply of hydroxycobalamin faces challenges including raw material shortages (notably cobalt), geopolitical factors influencing trade, and regulatory hurdles. Advances in fermentation technology and increased global production capacity aim to mitigate these issues, presenting opportunities for diversification of supply sources.
Conclusion
The global landscape for hydroxycobalamin suppliers is characterized by prominent multinational corporations like Merck KGaA, supplemented by regional players from India, China, and Israel. For pharmaceutical companies and healthcare providers, establishing partnerships with suppliers demonstrating regulatory compliance, quality assurance, and stable supply chains is paramount. As demand for vitamin B12 derivatives continues to grow, diversified sourcing strategies will be essential to ensuring consistent availability.
Key Takeaways
- Major Suppliers: Merck KGaA, ELCOS Pharma, Fermentek, Tianjin Tianyao Pharmaceutical, and Shanghai Pharma dominate the hydroxycobalamin market.
- Source Diversification: Regional suppliers in Asia and Eastern Europe serve local markets, often at competitive prices.
- Critical Selection Criteria: Regulatory compliance, product quality, pricing, and supply stability are key factors.
- Supply Chain Risks: Raw material shortages and geopolitical issues pose challenges; technological advances offer mitigation pathways.
- Future Trends: Increasing automation and biotechnological innovations will likely expand manufacturing capacity and supply reliability.
FAQs
1. What are the primary applications of hydroxycobalamin in clinical medicine?
Hydroxycobalamin is mainly used to treat vitamin B12 deficiency and cyanide poisoning due to its high affinity for cyanide ions and role in correcting megaloblastic anemia linked to B12 deficiency.
2. How do regulatory standards impact hydroxycobalamin suppliers?
Suppliers must meet regulatory standards such as USP, European Pharmacopoeia, and JP to ensure the quality, safety, and efficacy of hydroxycobalamin. Regulatory compliance affects approval, export capability, and market access.
3. Are there regional differences in hydroxycobalamin manufacturing capacity?
Yes. Europe and North America have established high-capacity facilities. India and China have rapidly expanded manufacturing, often providing cost-effective options with compliance to international GMP standards.
4. What raw materials are critical in hydroxycobalamin production?
Cobalt salts are essential, along with nutrients for fermentation processes. The availability and quality of cobalt significantly influence production volumes.
5. How might technological innovations influence the hydroxycobalamin supply chain?
Advancements in fermentation and biosynthesis methods could enhance yield, purity, and scalability, reducing costs and mitigating raw material dependency.
Sources
[1] European Pharmacopoeia, Vitamin B12, Hydroxycobalamin standards.
[2] U.S. Food and Drug Administration (FDA), Pharmaceutical Quality Guidelines.
[3] Industry reports on vitamin B12 derivatives production and distribution.
[4] Company disclosures and product catalogs of Merck KGaA, ELCOS Pharma, Fermentek, Tianyi Pharmaceutical, and Shanghai Pharma.
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