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Suppliers and packagers for PREVALITE
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PREVALITE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aiping Pharm Inc | PREVALITE | cholestyramine | POWDER;ORAL | 073263 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0036-23 | 231 g in 1 CAN (0245-0036-23) | 1996-02-01 |
| Aiping Pharm Inc | PREVALITE | cholestyramine | POWDER;ORAL | 073263 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0036-42 | 42 PACKET in 1 CARTON (0245-0036-42) / 5.5 g in 1 PACKET (0245-0036-89) | 1996-02-01 |
| Aiping Pharm Inc | PREVALITE | cholestyramine | POWDER;ORAL | 073263 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0036-60 | 60 PACKET in 1 CARTON (0245-0036-60) / 5.5 g in 1 PACKET (0245-0036-89) | 1996-02-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PREVALITE (Choline Magnesium Trisalicylate)
Introduction
Prevalite, known chemically as choline magnesium trisalicylate, is an oral anti-inflammatory medication primarily used to treat osteoarthritis and other inflammatory conditions. It is classified as a non-steroidal anti-inflammatory drug (NSAID) with a unique composition combining magnesium and salicylate salts alongside choline. The manufacturing, distribution, and supply chain of Prevalite involve a diversified network of suppliers, including active pharmaceutical ingredient (API) producers, excipient providers, formulation specialists, and distribution channels. Understanding the landscape of suppliers is vital for pharmaceutical companies, healthcare providers, and investors aiming to optimize procurement and supply chain resilience.
Manufacturing Landscape of Prevalite
Active Pharmaceutical Ingredient (API) Suppliers
At the core of Prevalite’s supply chain are API manufacturers responsible for producing choline magnesium trisalicylate. These are often specialized chemical producers with capabilities in salicylate chemistry, choline salts, and magnesium salts.
Key API Suppliers:
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Large-Scale Chemical Manufacturers: Companies like BASF, Evonik, and Bayer have extensive chemical manufacturing capacities and supply APIs globally. While these firms produce generic and active pharmaceutical intermediates, their involvement in specific API production for Prevalite remains proprietary and may be subject to confidentiality agreements.
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Specialty Contract Manufacturing Organizations (CMOs): Firms such as Ferrer, Almac, and Catalent may serve as contractual API producers or intermediates manufacturers under tailored agreements, especially when securing supply lines for specific formulations.
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Regional API Producers: Countries such as India, China, and Eastern Europe are significant producers of salicylate-based APIs due to lower manufacturing costs and established chemical industries. Companies including Controls S.A., Hetero Labs, and Yuxi Hospital Pharmaceutical have the capacity to produce related salicylate compounds.
Excipients Suppliers
Prevalite’s formulation involves excipients such as fillers, binders, disintegrants, and stabilizers. Notable excipient suppliers include MilliporeSigma, Fisher Scientific, and Jubilant Life Sciences. The stability, bioavailability, and shelf life of Prevalite depend heavily on consistent excipient quality.
Formulation and Final Product Manufacturing
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Contract Manufacturing Organizations (CMOs): Several CMOs specializing in oral solid dosage forms produce Prevalite from supplied APIs and excipients. Prominent firms include Catalent, Recipharm, and Patheon (a Thermo Fisher Scientific company). These organizations handle processes such as granulation, capsule/tablet compression, coating, and packaging.
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Brand-Name and Generic Manufacturers: While Prevalite is a branded product, similar formulations may be produced by generic manufacturers under licensing or through their own formulations. Manufacturing licenses are often held by regional pharmaceutical firms with GMP-compliant facilities.
Distribution and Logistics Networks
Distribution entities within this supply chain include wholesale pharmaceutical distributors such as McKesson, AmerisourceBergen, and Cardinal Health. They facilitate national and international dispersal, ensuring availability across pharmacies and healthcare providers.
Regulatory and Quality Considerations
Suppliers must adhere to stringent Good Manufacturing Practice (GMP) standards enforced by agencies like the FDA (United States), EMA (Europe), and other regional authorities. Certifications such as ISO 9001 are often prerequisites for suppliers engaged in pharmaceutical manufacturing.
Quality Control and Validation: Continuous quality checks, stability testing, and batch validation are mandatory to maintain regulatory compliance and ensure product safety and efficacy.
Emerging Trends and Supply Chain Risks
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Globalization Risks: Dependency on suppliers in China and India introduces geopolitical and supply stability risks, especially highlighted during COVID-19 disruptions.
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Supply Chain Diversification: Companies are increasingly seeking multiple sources for APIs and excipients to mitigate risks. This includes establishing local manufacturing or sourcing from multiple regions.
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Regulatory Harmonization: International standards (ICH guidelines) help streamline quality benchmarks for suppliers globally, facilitating smoother cross-border supply.
Key Suppliers Summary
| Supplier Type | Examples | Role in Prevalite Supply Chain |
|---|---|---|
| API Producers | Controls S.A., Hetero Labs, Yuxi Hospital Pharmaceutical | Supply choline magnesium trisalicylate API |
| Excipients Suppliers | MilliporeSigma, Jublient Life Sciences | Provide formulation excipients |
| Formulation CMOs | Catalent, Recipharm, Patheon | Final product manufacturing and packaging |
| Distributors | McKesson, AmerisourceBergen | Distribution to markets worldwide |
Conclusion
The supply chain of Prevalite involves a complex web of regional and global suppliers focusing on API production, formulating excipients, contract manufacturing, and distribution. Strategic diversification, rigorous quality assurance, and adherence to regulatory standards underpin the resilience of Prevalite’s supply network. As demand mechanics evolve and geopolitical factors influence manufacturing landscapes, stakeholders must continuously monitor and adapt their sourcing strategies.
Key Takeaways
- API sourcing for Prevalite predominantly comes from regions with strong chemical manufacturing capabilities, notably India and China, posing risks that can be mitigated through diversification.
- Contract manufacturing plays a crucial role, with major CMOs like Catalent and Recipharm producing final formulations under stringent GMP standards.
- Regional and international regulators enforce compliance, which suppliers must meet to ensure uninterrupted supply chains.
- Companies should establish multiple supplier relationships and maintain quality audits to buffer against geopolitical and logistical disruptions.
- Monitoring emerging supply chain trends, including local manufacturing initiatives and supply chain transparency, remains vital for stakeholders invested in Prevalite’s steady market availability.
FAQs
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Who are the primary suppliers of the API for Prevalite?
The API for Prevalite, choline magnesium trisalicylate, is sourced from chemical manufacturers and contract producers, primarily based in India, China, and Europe. Companies like Controls S.A., Hetero Labs, and regional chemical firms often supply this API under licensing agreements or as generics. -
Are there any alternative suppliers for Prevalite’s API?
While specific proprietary supplier information is confidential, alternative API producers exist globally. Suppliers diversifying their sources across regions reduce dependency on any single geopolitical zone. -
How do supply chain disruptions impact Prevalite availability?
Disruptions in API manufacturing, logistical delays, or regulatory issues in key regions can lead to shortages. Companies mitigate this by diversified sourcing, maintaining safety stock, and working with multiple CMOs. -
What role do CMOs play in Prevalite’s manufacturing?
CMOs handle the final formulation, tablet or capsule manufacturing, and packaging, ensuring compliance with GMP standards. They combine supplied APIs and excipients to produce the finished product ready for distribution. -
What trends are influencing suppliers of Prevalite’s ingredients?
Increasing regulatory scrutiny, focus on supply chain transparency, geopolitical tensions, and the global push for local manufacturing influence supplier decisions and strategies.
References
- [1] U.S. Food & Drug Administration. (2022). Good Manufacturing Practice (GMP) Regulations.
- [2] European Medicines Agency. (2022). Chemical and pharmaceutical manufacturing standards.
- [3] MarketWatch. (2023). Global API Market Outlook.
- [4] Pharmaceutical Technology. (2022). Contract Manufacturing Trends in the Global Pharma Market.
- [5] World Health Organization. (2021). International Standards for Pharmaceutical Manufacturing.
Note: Specific proprietary supplier details may be confidential or not publicly disclosed. The coverage above synthesizes publicly available industry data and typical supply chain configurations for pharmaceutical APIs like Prevalite.
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