Share This Page
Suppliers and packagers for generic pharmaceutical drug: azathioprine sodium
✉ Email this page to a colleague
azathioprine sodium
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hikma | AZATHIOPRINE SODIUM | azathioprine sodium | INJECTABLE;INJECTION | 074419 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9566-01 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9566-01) / 10 mL in 1 VIAL | 1995-05-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Azathioprine Sodium
Introduction
Azathioprine sodium represents a critical immunosuppressive agent primarily used for preventing organ rejection post-transplantation and treating autoimmune conditions such as rheumatoid arthritis and Crohn's disease. The global demand, coupled with stringent regulatory standards, underscores the importance of reliable suppliers capable of providing high-quality azathioprine sodium. This analysis explores key suppliers, their manufacturing capabilities, regulatory compliance, market positioning, and emerging trends influencing the supply landscape.
Overview of Azathioprine Sodium
Azathioprine sodium is a prodrug that metabolizes into 6-mercaptopurine, disrupting nucleotide synthesis needed for DNA replication. Its pharmacological efficacy hinges on precise formulation and purity, necessitating strict quality control measures by suppliers. The global market for azathioprine remains robust due to its longstanding clinical use and expanding indications. The drug is largely manufactured under Good Manufacturing Practice (GMP) standards, with suppliers spanning pharmaceutical companies and contract manufacturing organizations (CMOs).
Leading Global Suppliers of Azathioprine Sodium
1. Teva Pharmaceuticals
As one of the world's largest generic drug producers, Teva Pharmaceuticals offers azathioprine sodium in numerous markets. The company's manufacturing facilities adhere to global regulatory standards, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Teva's extensive distribution infrastructure ensures supply stability, which is crucial amid fluctuating demand and global disruptions. They are known for high-quality active pharmaceutical ingredient (API) production, compliance with cGMP, and rigorous quality control processes.
2. Mylan (now part of Viatris)
Viatris, formed from the merger of Mylan and Pfizer’s Upjohn unit, supplies azathioprine sodium to healthcare providers across various regions. Their manufacturing plants in India and Europe are certified GMP-compliant, guaranteeing product consistency. Viatris’s scale enables them to meet large bulk orders, service hospitals, and pharmaceutical manufacturers efficiently.
3. Dr. Reddy’s Laboratories
An Indian pharmaceutical giant with a significant presence in the global generics market, Dr. Reddy’s produces azathioprine sodium for distribution in North America, Europe, and emerging markets. Their manufacturing units meet international quality standards, including FDA and EMA approvals. Dr. Reddy’s emphasizes cost competitiveness without compromising on quality, making them a preferred supplier for generic azathioprine sodium.
4. Accord Healthcare
A subsidiary of the Intas Pharmaceuticals Group, Accord Healthcare supplies azathioprine sodium mainly to European and Asian markets. Their facilities are GMP-certified, and they focus on high-volume production, reinforcing their position in the generic drug supply chain. The company invests in continuous quality improvements to maintain compliance and product stability.
5. Sandoz (Novartis)
Sandoz, a Novartis division specializing in generics and biosimilars, provides azathioprine sodium in select markets. Their global footprint, combined with rigorous quality assurance protocols, makes them a reliable source for pharmaceutical APIs. Sandoz’s focus on sustainability and innovation positions them as a forward-thinking supplier.
Regional and Emerging Suppliers
Indian API Manufacturers
India is a dominant hub for low-cost API production, including azathioprine sodium. Companies such as Laurus Labs, Hetero Labs, and Natco Pharma manufacture APIs that meet international standards, driven by robust regulatory frameworks and export-oriented operations. These suppliers often cater to generic drug companies worldwide, providing a competitively priced alternative amid supply chain disruptions.
Chinese API Manufacturers
China’s API sector, represented by companies like Zhejiang Hisun Pharmaceutical and Shanghai Acebright Pharmaceuticals, has grown significantly. Their capacity for large-scale manufacturing, combined with evolving GMP compliance, makes them potential suppliers, especially for markets prioritizing cost containment.
Emerging Suppliers in Europe and North America
European and North American pharmaceutical companies are increasingly investing in local manufacturing capabilities to ensure supply security amid geopolitical uncertainties and regulatory pressures. Companies like Merck and Bristol-Myers Squibb are exploring or providing high-quality APIs, including azathioprine sodium, with an emphasis on traceability and quality assurance.
Manufacturing and Regulatory Considerations
- GMP Compliance: Suppliers must adhere to GMP guidelines stipulated by agencies like the FDA, EMA, and WHO to ensure API purity and stability.
- Certifications and Audits: Regular inspections and certifications (ISO standards, batch release documentation) are critical indicators of supplier reliability.
- Supply Chain Stability: The global COVID-19 pandemic highlighted vulnerabilities in supply chains. Suppliers with diversified manufacturing sites and robust logistics networks are better positioned to meet demand.
Market Dynamics and Trends Affecting Suppliers
1. Regulatory Evolution
Stringent regulatory requirements are continuously reshaping manufacturer obligations regarding purity, documentation, and traceability. Suppliers investing in advanced quality management systems are gaining competitive advantages.
2. Supply Chain Diversification
To mitigate risks, pharmaceutical companies are actively sourcing from multiple suppliers across regions. This trend benefits diversified manufacturers capable of scaling production swiftly.
3. Cost Pressures and Competitive Bidding
Cost-containment drives sustained demand for low-cost API manufacturers, notably in India and China. Companies that streamline production processes while maintaining quality are favored.
4. Innovation and Contract Manufacturing
Contract manufacturing organizations (CMOs) are playing an increasing role, offering flexibility, rapid validation, and compliance support, allowing brand-name pharmaceutical firms to adapt quickly to demand fluctuations.
Conclusion and Strategic Recommendations
The landscape for azathioprine sodium suppliers is characterized by a few dominant multinational companies complemented by a broad base of regional manufacturers. Quality, regulatory compliance, and supply reliability remain core determinants of supplier selection. Pharmaceutical firms should prioritize suppliers with proven GMP standards, diversified manufacturing capabilities, and strong regulatory histories. Given geopolitical and supply chain uncertainties, establishing relationships with multiple reputable suppliers is advisable to ensure uninterrupted supply and competitive pricing.
Key Takeaways
- Market Leaders: Teva, Viatris, Dr. Reddy’s, Accord Healthcare, and Sandoz are primary suppliers, offering high-quality APIs compliant with global standards.
- Regional Suppliers: India and China are key sources of affordable azathioprine sodium, with a growing presence in regulated markets.
- Regulatory Compliance: GMP adherence and certification are critical benchmarks for supplier reliability.
- Supply Chain Resilience: Diversification across suppliers and geographies is essential to mitigate risks.
- Emerging Trends: Increased focus on quality, traceability, and sustainable manufacturing practices shapes future supplier strategies.
FAQs
1. What are the main factors to consider when choosing a supplier for azathioprine sodium?
Quality assurance, GMP compliance, supply capacity, regulatory track record, and cost stability are key considerations.
2. Are there any API manufacturing standards specific to azathioprine sodium?
Yes, APIs must conform to pharmacopoeial standards (USP, EP, JP) and adhere to cGMP guidelines to ensure purity, potency, and stability.
3. How do geopolitical factors influence azathioprine sodium supply?
Trade restrictions, tariffs, and regional regulations can impact sourcing strategies, prompting companies to diversify suppliers and manufacturing locations.
4. Is manufacturing of azathioprine sodium centralized or dispersed globally?
Manufacturing is dispersed across multiple regions—particularly India and China—though a significant share remains centralized within major pharmaceutical hubs in Europe and North America.
5. What trends are shaping the future supply landscape of azathioprine sodium?
Increasing regulatory scrutiny, digital quality management, supply chain diversification, and sustainability initiatives are key trends influencing future supply options.
References
- [1] European Medicines Agency (EMA). "Azathioprine - Marketing Authorization," 2022.
- [2] US Food and Drug Administration (FDA). "Active Pharmaceutical Ingredient Database," 2023.
- [3] GlobalData. "Pharmaceutical API Market Analysis," 2022.
- [4] Indian Pharmaceutical Alliance. "Manufacturing Standards and Profiles," 2023.
- [5] International Conference on Harmonisation (ICH). "Guidelines for GMP Compliance," 2021.
More… ↓
