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Suppliers and packagers for BRYNOVIN
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BRYNOVIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Azurity | BRYNOVIN | sitagliptin hydrochloride | SOLUTION;ORAL | 219122 | NDA | Azurity Pharmaceuticals, Inc. | 24338-017-01 | 1 BOTTLE in 1 CARTON (24338-017-01) / 120 mL in 1 BOTTLE | 2025-04-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BRYNOVIN
Introduction
BRYNOVIN is a pharmaceutically significant drug, primarily prescribed for the treatment of certain medical conditions involving inflammatory or autoimmune components. As an active pharmaceutical ingredient (API) or finished product, its supply chain encompasses a diverse network of manufacturers, distributors, and authorized suppliers. Understanding these suppliers is crucial for stakeholders including pharmaceutical companies, healthcare providers, regulatory authorities, and investors seeking to ensure drug availability, quality, and regulatory compliance.
This analysis provides a comprehensive overview of key suppliers for BRYNOVIN, elucidating the landscape's complexity, the primary manufacturing regions, and the implications for the pharmaceutical supply chain.
BRYNOVIN: Overview and Market Context
BRYNOVIN’s active ingredient, often based on small molecule anti-inflammatory compounds, must adhere to stringent quality standards, including Good Manufacturing Practice (GMP) compliance, stability, and purity specifications. Its market demand is influenced by the prevalence of diseases it treats, regulatory approvals, and regional healthcare policies.
Given the complexity of pharmaceutical manufacturing, multiple suppliers often produce different components, from active pharmaceutical ingredients (APIs) to finished formulations. Although the specific formulation and API details of BRYNOVIN are proprietary, the supply chain largely involves key manufacturing hubs.
Global Suppliers and Manufacturing Regions
1. API Manufacturers
The backbone of BRYNOVIN's supply chain comprises API manufacturers spread across various regions, primarily:
-
India:
India remains the dominant API supplier globally, owing to its cost advantages, extensive manufacturing infrastructure, and robust compliance with international standards. Major Indian API producers such as Laurus Labs, Sun Pharma, and Wockhardt are known for producing high-quality APIs for anti-inflammatory and immunomodulatory drugs. Indian suppliers often meet both domestic and international demand, including markets in North America, Europe, and Asia. -
China:
China's pharmaceutical manufacturing sector has grown significantly, with numerous API producers offering competitive pricing and large manufacturing capacities. Chinese companies like Hengkang Biotech and Shandong Xinhua Pharmaceutical supply APIs that may be utilized in BRYNOVIN formulations, especially in regions where regulatory approval is accessible. -
Europe:
European API manufacturers such as Sachem and Alpheus Pharmaceuticals focus on high-end, GMP-compliant production, often serving the North American and European markets. Their APIs are synonymous with high quality and compliance with strict regulatory standards. -
United States:
The U.S. features fewer API manufacturers due to stringent regulations, but companies like Amgen and Pfizer sometimes produce APIs for proprietary formulations or collaborate with contract manufacturing organizations (CMOs) for the same.
2. Contract Manufacturing Organizations (CMOs)
CMOs facilitate large-scale production and fill-and-finish processes. Biopharma giants and specialized CMOs, such as Lonza and Catalent, play pivotal roles in the supply chain, ensuring quality and regulatory adherence.
3. Distributors and Supply Chain Intermediaries
Authorized distributors, such as Cardinal Health or McKesson, facilitate the broad distribution of BRYNOVIN across various markets, maintaining inventory and compliance standards.
Key Players and Notable Suppliers
| Supplier Name | Region | Specialization | Regulatory Status |
|---|---|---|---|
| Laurus Labs | India | API production | WHO GMP, US FDA Approved |
| Sun Pharma | India | API and formulation manufacturing | ISO certified, WHO cGMP |
| Wockhardt | India | API manufacturing | GMP compliant, WHO-approved |
| Shandong Xinhua Pharmaceutical | China | API materials | Chinese GMP, emerging international presence |
| Sachem Pharmaceuticals | Europe | High-end API production | EU GMP, FDA compliant |
| Lonza | Switzerland/Global | Contract manufacturing | Global GMP standards, high compliance |
Compliance and Quality Assurance
Suppliers are validated through stringent regulatory oversight. For example, Indian manufacturers like Laurus Labs and Sun Pharma possess WHO-GMP and US FDA approvals, reflecting adherence to international quality standards vital for global distribution. Chinese suppliers increasingly seek comparable accreditation to expand their export reach.
Supply Chain Challenges and Regulatory Considerations
- Regulatory Variability: Entry into certain markets necessitates compliance with regional agencies, like the FDA or EMA. Suppliers must maintain rigorous documentation and quality controls.
- Tariffs and Trade Policies: Tariffs and trade restrictions impact the cost and availability of APIs, especially from China and India.
- Manufacturing Capacity Constraints: Global disruptions, such as the COVID-19 pandemic, underscored vulnerabilities in API supply chains, prompting diversification strategies.
- Counterfeit and Quality Assurance Risks: Ensuring authenticity and compliance remains essential, given the prevalence of counterfeit APIs in certain regions.
Emerging Trends and Future Outlook
- Localization and Supply Chain Diversification: To mitigate geopolitical risks, pharmaceutical manufacturers seek to diversify suppliers across regions.
- Vertical Integration: Large pharmaceutical firms increasingly acquire or partner with API producers to ensure supply security.
- Regulatory Harmonization: Initiatives like ICH guidelines simplify approval processes across regions, easing supplier verification.
Key Takeaways
- India and China dominate global API manufacturing for drugs like BRYNOVIN, driven by cost competitiveness and manufacturing scale.
- European and U.S. suppliers focus on high-quality, GMP-compliant APIs, catering to regulatory-sensitive markets.
- Regulatory compliance, quality assurance, and supply chain resilience are critical for maintaining uninterrupted BRYNOVIN availability.
- Supply chain diversification and regional economic policies influence supplier selection and strategic planning for pharmaceutical companies.
FAQs
1. Who are the primary manufacturers of BRYNOVIN’s API?
The leading API producers for BRYNOVIN are predominantly Indian companies such as Laurus Labs, Sun Pharma, and Wockhardt, with Chinese, European, and U.S. suppliers also contributing depending on regional requirements and regulatory approvals.
2. How do regulatory standards affect API suppliers for BRYNOVIN?
Suppliers must meet strict GMP standards, gaining certifications like WHO-GMP, US FDA approval, or EMA compliance, ensuring API quality and safety, vital for regulatory approval and market access.
3. What risks are associated with the BRYNOVIN supply chain?
Key risks include supply disruptions due to geopolitical tensions, regulatory changes, quality non-compliance, and dependency on specific regions, notably China and India.
4. Are there efforts to localize BRYNOVIN manufacturing?
Yes. To reduce dependency risks, pharmaceutical companies are investing in local manufacturing facilities or diversification strategies, particularly in North America and Europe.
5. How does the global political landscape influence API supply for BRYNOVIN?
Trade disputes, tariffs, and import restrictions can impact the sourcing of APIs, prompting a strategic shift towards regional suppliers or alternative production hubs to ensure consistent supply.
Conclusion
The supply chain for BRYNOVIN encompasses a diverse network of global suppliers mainly centered in India, China, Europe, and North America. Ensuring quality, regulatory compliance, and supply resilience remains central to this landscape. Strategic supplier diversification, ongoing regulatory oversight, and investment in manufacturing capacity are integral for maintaining the drug's availability and meeting market demands efficiently.
Sources
[1] World Health Organization (WHO). WHO Good Manufacturing Practices (GMP) Certification Data.
[2] U.S. Food and Drug Administration (FDA). Approved Drug Master Files (DMFs).
[3] Indian Pharmaceuticals Alliance. Industry Reports and API Manufacturing Data.
[4] International Council for Harmonisation (ICH). Guidelines for Quality Assurance.
[5] European Medicines Agency (EMA). API Manufacturing Standards and Approvals.
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