Suppliers and packagers for pifeltro

pifeltro

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msd Merck Co	PIFELTRO	doravirine	TABLET;ORAL	210806	NDA	Merck Sharp & Dohme LLC	0006-3069-01	30 TABLET, FILM COATED in 1 BOTTLE (0006-3069-01)	2018-07-20
Msd Merck Co	PIFELTRO	doravirine	TABLET;ORAL	210806	NDA	A-S Medication Solutions	50090-6268-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-6268-0)	2018-07-20

Suppliers for the Pharmaceutical Drug: Pifeltro (Doravirine)

Last updated: July 31, 2025

Introduction

Pifeltro (doravirine) is an antiretroviral medication developed by Merck & Co., Inc., primarily prescribed for the treatment of HIV-1 infection. As a non-nucleoside reverse transcriptase inhibitor (NNRTI), Pifeltro plays a critical role in combination antiretroviral therapy (ART) regimens. The supply chain for Pifeltro encompasses a network of raw material providers, active pharmaceutical ingredient (API) producers, formulation manufacturers, and distribution channels. For industry stakeholders and healthcare providers, understanding the key suppliers and the dynamics of its procurement is essential for ensuring consistent access, scalability, and compliance with regulatory standards.

Active Pharmaceutical Ingredient (API) Suppliers

The foundation of Pifeltro’s supply chain hinges on the procurement of high-quality API — doravirine. Manufacturing of the API involves complex chemical synthesis, regulatory compliance, and stringent quality controls. Currently, Merck’s supply chain for doravirine is reportedly reliant on multiple API suppliers globally, often located in regions with established pharmaceutical manufacturing capabilities such as India, China, and Europe.

Major API Manufacturers

1. Global Contract Manufacturers (CMOs):
   Several Contract Manufacturing Organizations (CMOs) specializing in complex chemical synthesis are typical API suppliers for drugs like doravirine. These entities often operate under strict regulatory standards (ICH Q7, FDA, EMA) to supply APIs for global markets.

2. Indian and Chinese API Producers:

   • CIPLA Ltd. and Dr. Reddy’s Laboratories are prominent Indian pharmaceutical companies with extensive API manufacturing capacities. They have reportedly produced APIs for antiretroviral drugs, possibly including doravirine, leveraging their expertise in chemical synthesis and cost efficiency.
   • Shanghai Fosun Pharmaceutical (Fosun Pharma): A Chinese manufacturer with growing capacity in HIV-related APIs, potentially serving as an API supplier for global markets.

3. European API Providers:

   • Several European pharmaceutical companies with specialized chemical synthesis resources supply APIs for commercialized HIV drugs, emphasizing high purity and regulatory compliance.

Note: Specific supplier identities for doravirine API are often confidential due to commercial agreements and proprietary manufacturing processes. Merck, as the originator, likely maintains strategic partnerships with selected API manufacturers to safeguard supply chain integrity.

Formulation and Finished Dosage Product Suppliers

Once the API is procured, pharmaceutical formulation companies are responsible for producing the final Pifeltro tablets. These manufacturers often operate under contract with Merck, adhering to strict Good Manufacturing Practice (GMP) standards.

1. Merck & Co.:
   As the patent holder and primary supplier, Merck manufactures Pifeltro at its own facilities, ensuring quality control and regulatory compliance.

2. Contract Manufacturing Organizations:
   Other pharmaceutical contract manufacturers may produce finished dosages for regional markets, especially in countries with complex import regulations or customization needs.

Distribution and Supply Chain Dynamics

The distribution network for Pifeltro involves regional warehouses, global health agencies, and healthcare providers. Ensuring a resilient supply chain amid disruptions (e.g., COVID-19 pandemic, geopolitical factors) relies on diversified supplier bases, strategic inventory management, and robust logistics partnerships.

Regulatory Considerations and Quality Assurance

Both API and finished product suppliers must comply with stringent regulatory standards—i.e., the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national agencies. Validated manufacturing facilities, comprehensive quality assurance programs, and regular inspections underpin the legitimacy of supply.

Strategic Collaborations and Market Access

Merck’s approach typically involves securing strategic partnerships with multiple API suppliers to mitigate risks of shortages and to ensure market scalability. Such collaborations leverage regional manufacturing capabilities while maintaining quality, cost-effectiveness, and regulatory compliance.

Conclusion

The supply chain for Pifeltro (doravirine) is characterized by reliance on a select group of reputable API manufacturers, primarily based in India, China, and Europe, coupled with Merck's in-house formulation and distribution capabilities. The robustness of this network ensures consistent patient access while navigating regulatory and geopolitical shifts. Stakeholders should monitor these supplier relationships, regulatory changes, and geopolitical factors impacting the global supply chain.

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Key Takeaways

• API sourcing for Pifeltro predominantly involves Indian, Chinese, and European manufacturers specializing in complex chemical synthesis.
• Merck’s vertical integration allows for direct control over formulation and distribution, reducing dependency on external suppliers.
• Regulatory compliance is critical; suppliers must adhere to GMP standards set by FDA, EMA, and other authorities.
• Diversification of suppliers mitigates risks of shortages due to geopolitical or supply chain disruptions.
• Monitoring supplier relationships and regulatory landscapes enhances strategic planning and market resilience.

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FAQs

1. Who are the primary API suppliers for Pifeltro (doravirine)?
   While specific supplier identities are confidential, major players likely include Indian companies such as CIPLA and Dr. Reddy’s, Chinese manufacturers like Fosun Pharma, and European specialty chemical producers, all operating under strict regulatory standards.

2. Does Merck manufacture Pifeltro in-house or outsource?
   Merck primarily produces Pifeltro internally but may contract certain API manufacturing processes to trusted third-party suppliers to ensure supply and manage costs.

3. What factors influence the stability of Pifeltro’s supply chain?
   Factors include geopolitical stability, regulatory compliance, raw material availability, quality standards, and global logistics infrastructure.

4. Are there alternative sources for doravirine API?
   Currently, supply is concentrated among a few established manufacturers. Efforts are ongoing within the industry to diversify and expand sourcing options for critical HIV medications.

5. How does regulatory compliance impact suppliers of Pifeltro?
   Suppliers must maintain GMP certification and submit regular compliance documentation to authorities like the FDA and EMA, which influences their eligibility and capacity to supply APIs for Pifeltro.

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Sources

[1] Merck & Co. official product and regulatory information.
[2] Industry reports on HIV drug supply chains and API manufacturing.
[3] WHO prequalification documents and API manufacturer registries.
[4] Global pharmaceutical manufacturing analyses.
[5] Recent regulatory submission insights and partnership disclosures by Merck.