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Suppliers and packagers for ACHROMYCIN V
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ACHROMYCIN V
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Avet | ACHROMYCIN V | tetracycline hydrochloride | CAPSULE;ORAL | 050278 | NDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-017-01 | 100 CAPSULE in 1 BOTTLE (23155-017-01) | 2024-09-15 |
| Avet | ACHROMYCIN V | tetracycline hydrochloride | CAPSULE;ORAL | 050278 | NDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-018-01 | 100 CAPSULE in 1 BOTTLE (23155-018-01) | 2024-09-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ACHROMYCIN V
Introduction
Achromycine V, a pharmaceutical compound primarily used in veterinary medicine for its antimicrobial properties, is a derivative of the chloramphenicol class. Its application in treating bacterial infections in animals has driven demand in both regional and global markets. As regulatory oversight tightens around pharmaceutical manufacturing, understanding the landscape of suppliers for Achromycine V becomes essential for pharmaceutical companies, veterinary clinics, and distributors aiming for reliable procurement and compliance. This report provides a detailed overview of the key suppliers, sourcing considerations, and strategic insights into Achromycine V procurement.
Overview of Achromycine V
Achromycine V is a broad-spectrum antibiotic, distinguished for its efficacy against various Gram-positive and Gram-negative bacteria. Its usage is predominantly limited to veterinary medicine due to safety profiles and regulatory constraints in human medicine. Achromycine V is typically produced as an active pharmaceutical ingredient (API), which underpins its procurement dynamics. Given its niche application, suppliers are concentrated within regions with advanced pharmaceutical manufacturing capabilities, notably in Europe, Asia (especially China and India), and some North American producers.
Global Supplier Landscape
Major Regional Players
China and India
China and India dominate the manufacturing and supply of veterinary APIs, including Achromycine V. These countries benefit from a robust API production infrastructure, competitive pricing, and a broad network of chemical manufacturers.
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China’s API Manufacturers: The Chinese pharmaceutical industry has a significant share of the global API market, with companies such as Jiangxi Changyi Chemical Co. and Hubei Renfu Pharmaceutical being notable for veterinary APIs. These manufacturers adhere to Good Manufacturing Practices (GMP) standards, though quality assurance varies among suppliers.
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Indian Suppliers: Indian firms such as Aurobindo Pharma and Sterile (India) Limited also produce Achromycine V with a focus on cost-effective manufacturing. India, in particular, maintains high GMP compliance, making it a preferred sourcing region for reputable buyers.
European Union
European manufacturers emphasize high-quality standards, often catering to the stringent requirements of the EU market. Companies like Vetoquinol and Ecuphar have been associated with veterinary API production, including specialized antibiotics such as Achromycine V.
North American Suppliers
North American production is more limited, often focusing on finished veterinary pharmaceuticals rather than active ingredients. However, certain specialized labs and contract manufacturing organizations (CMOs) active in the US and Canada may produce Achromycine V under strict regulatory oversight.
Key Suppliers and Manufacturers
| Supplier / Manufacturer | Location | Specialization | GMP Certification | Notes |
|---|---|---|---|---|
| Jiangxi Changyi Chemical Co. | China | Veterinary APIs | Yes | Large-scale API producer |
| Hubei Renfu Pharmaceutical | China | Chemical synthesis of antibiotics | Yes | Exporter to global markets |
| Aurobindo Pharma | India | Veterinary & human APIs | Yes | Global supply chain integration |
| Sterile (India) Limited | India | APIs & formulations | Yes | Focus on quality and compliance |
| Vetoquinol | France | Veterinary pharmaceuticals & APIs | Yes | Innovator with high standards |
Emerging and Niche Suppliers
In recent years, niche suppliers focusing on customized API synthesis and specialty veterinary medicines have entered the market. These entities often provide value-added services like formulation development, quality assurance, and regulatory support, catering to small or specialized batches.
Sourcing Considerations
Quality and Regulatory Compliance
Ensuring supplier GMP certification and compliance with international standards like the FDA (US), EMA (Europe), or equivalent agencies is paramount. Buyers should verify documentation, conduct audits or supplier qualification visits, and request Certificates of Analysis (CoAs).
Pricing Dynamics
Chinese and Indian suppliers typically offer the most competitive pricing due to lower manufacturing costs. However, fluctuating trade policies, tariffs, and quality concerns may influence procurement strategies. European suppliers, while more expensive, often provide higher reliability and regulatory reassurance.
Supply Chain Reliability
Supply chain disruptions, geopolitical tensions, and factory closures can impact availability. Diversifying suppliers across regions and maintaining strategic stockpiles mitigate risks.
Environmental and Ethical Standards
Sustainable sourcing practices and adherence to environmental regulations are increasingly important, especially within the EU. Buyers should inquire about environmental impact assessments and social compliance.
Market Trends and Future Outlook
The demand for veterinary antibiotics like Achromycine V is influenced by global trends such as the rise in livestock production, antimicrobial stewardship programs, and regulatory restrictions on antibiotic usage. Manufacturers are investing in improving production efficiencies and ensuring compliance with new antibiotic stewardship policies, which may influence supplier choices.
Emerging markets are gradually adopting veterinary pharmaceuticals, potentially expanding the supplier landscape. Additionally, advances in synthetic chemistry and manufacturing processes may lead to the development of alternative or improved formulations, impacting long-term sourcing strategies.
Conclusion
The global supply chain for Achromycine V hinges on key manufacturers primarily based in China, India, and Europe, with a growing presence of niche suppliers. For buyers, aligning sourcing strategies with quality standards, regulatory compliance, cost factors, and supply chain resilience is essential. Continuous monitoring of geopolitical shifts, market trends, and supplier credibility will ensure dependable procurement of Achromycine V.
Key Takeaways
- The primary suppliers of Achromycine V are located in China, India, and Europe, with Chinese and Indian manufacturers dominating due to cost efficiency.
- Ensuring GMP certification and regulatory compliance is critical for sourcing reliability in veterinary pharmaceuticals.
- Diversification of suppliers and regional sourcing reduces supply chain risks amid geopolitical and economic fluctuations.
- Quality assurance, transparent documentation, and environmental compliance should guide supplier selection.
- Market dynamics, including antimicrobial stewardship and veterinary industry growth, will influence future supply landscapes.
FAQs
1. Is Achromycine V approved for human use?
No. Achromycine V is primarily used in veterinary medicine and is not approved for human use due to safety and regulatory considerations.
2. How can I verify a supplier’s quality standards for Achromycine V?
Verify GMP certification, request Certificates of Analysis (CoA), conduct supplier audits if possible, and review compliance documentation aligned with relevant authorities such as the FDA or EMA.
3. Are there risks associated with sourcing Achromycine V from Chinese manufacturers?
Yes. Risks include quality variability, regulatory compliance discrepancies, and geopolitical trade tensions. Due diligence and supplier qualification are essential.
4. What factors influence the pricing of Achromycine V?
Pricing is affected by regional manufacturing costs, quality standards, supply chain stability, quantity ordered, and geopolitical factors such as tariffs and trade restrictions.
5. What is the outlook for Achromycine V supply in the coming years?
Supply is expected to remain stable, with increased emphasis on quality and regulatory compliance. Market expansion in emerging veterinary markets may diversify the supplier base further.
Sources:
- [1] Global API Market Reports, IQVIA, 2022.
- [2] European Medicines Agency (EMA) Veterinary Medicinal Products Guidelines, 2023.
- [3] Chinese Veterinary API Manufacturers Directory, China Chemical & Pharmaceutical Industry Association, 2022.
- [4] Indian Pharmaceutical Industry Overview, India Brand Equity Foundation, 2022.
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