Suppliers and packagers for generic pharmaceutical drug: NELFINAVIR MESYLATE

NELFINAVIR MESYLATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Agouron Pharms	VIRACEPT	nelfinavir mesylate	TABLET;ORAL	020779	NDA	AGOURON	63010-010-30	300 TABLET, FILM COATED in 1 BOTTLE (63010-010-30)	1997-03-14
Agouron Pharms	VIRACEPT	nelfinavir mesylate	TABLET;ORAL	021503	NDA	AGOURON	63010-027-70	120 TABLET, FILM COATED in 1 BOTTLE (63010-027-70)	2003-04-30

Suppliers for the Pharmaceutical Drug: Nelfinavir Mesylate

Last updated: July 29, 2025

Introduction

Nelfinavir mesylate, marketed under the trade name Viracept among others, is an antiretroviral medication primarily used to treat HIV infections. As a protease inhibitor, nelfinavir plays a vital role in combination therapies aimed at suppressing HIV replication. The global demand for nelfinavir mesylate depends heavily on trusted suppliers capable of delivering high-quality, regulated pharmaceutical-grade compounds. This article examines the key players in the supply chain of nelfinavir mesylate, highlighting their manufacturing capabilities, market positioning, and compliance standards essential for pharmaceutical procurement.

Manufacturers of Nelfinavir Mesylate

Several pharmaceutical companies and generic drug manufacturers are actively involved in producing nelfinavir mesylate. They can be broadly categorized into original innovators and generic manufacturers. The following analysis explores these groups in detail.

1. Original Innovator Manufacturers

AbbVie (formerly part of Abbott Laboratories)

AbbVie was the original patent holder and source of nelfinavir mesylate when it was first approved by the U.S. Food and Drug Administration (FDA) in 1997. Their manufacturing facilities adhere strictly to Good Manufacturing Practices (GMP), ensuring high purity and consistent potency. As patent exclusivity has expired in many regions, AbbVie's role has shifted from manufacturing to licensing and licensing collaborations, but they remain a credible supplier in regions where patent protections are still active.

Key Attributes:

• Certified GMP facilities
• Strict regulatory compliance standards (FDA, EMA, etc.)
• Proprietary formulations and patents (where applicable)

2. Leading Generic Manufacturers

Once patents expired—particularly around 2010—numerous generic pharmaceutical companies entered the market, significantly expanding supply options. The following are some prominent producers:

a. Mylan

Mylan, now part of Viatris after its merger with Pfizer's generics division, has established a significant manufacturing footprint producing nelfinavir mesylate globally. Their facilities operate under international GMP standards, and they distribute extensively across North America, Europe, Asia, and emerging markets.

b. Cipla

An Indian pharmaceutical giant, Cipla has a long history of producing antiretroviral drugs, including nelfinavir mesylate. Cipla’s manufacturing is certified by WHO-GMP and various national regulatory agencies, ensuring that their products are suitable for global markets, especially in resource-limited settings.

c. Aurobindo Pharma

Aurobindo Pharma is another leading Indian manufacturer capable of supplying nelfinavir mesylate. Their facilities are certified by USFDA, UK MHRA, and other regulatory agencies, underscoring their compliance with international quality standards.

d. Hetero Labs

Hetero Labs specializes in high-quality APIs and formulary drugs, including nelfinavir mesylate, with active compliance under global regulatory frameworks. Their manufacturing plants adhere to GMP standards, and they export extensively across Africa, Asia, and Latin America.

e. Cadila Healthcare (Zydus Cadila)

Zydus Cadila is recognized for its biopharmaceuticals and API production, including nelfinavir mesylate. The company’s facilities meet USFDA and other stringent approval standards, positioning it as a reliable supplier for global health programs.

3. Contract Manufacturing Organizations (CMOs)

Some larger pharmaceutical companies utilize CMOs for the production of nelfinavir mesylate, especially for large-volume or regional supply needs. Notable CMOs include Dr. Reddy's Laboratories and STADA, which offer high-quality manufacturing services aligned with international GMP regulations.

4. Regional & Emerging Market Suppliers

In addition to large, global players, several regional suppliers serve local markets. These include manufacturers in China, Vietnam, and Brazil, where governmental agencies often oversee quality controls. They may offer cost-effective options but require thorough due diligence to confirm regulatory compliance.

Regulatory & Quality Assurance Standards

Procurement of nelfinavir mesylate requires stringent adherence to international quality standards. Suppliers must demonstrate compliance with GMP, ISO certifications, and specific country-specific regulatory approvals (FDA, EMA, PMDA, etc.). Verification processes often involve auditing manufacturing facilities, reviewing Certificate of Analysis (CoA), and ensuring batch-to-batch consistency.

Market Dynamics & Supply Chain Considerations

The landscape of suppliers for nelfinavir mesylate continues to evolve, driven by patent expirations, global health initiatives, and emerging markets’ demand. Key considerations for stakeholders include:

• Patent Status & Regulatory Exclusivity: Patent expirations globally have enabled a surge in generic suppliers, increasing accessibility but raising concerns regarding supply consistency and quality assurance.
• Price & Cost-Effectiveness: Competition among suppliers drives prices down, particularly important for procurement in low- and middle-income countries.
• Supply Chain Resilience: The recent global disruptions, such as the COVID-19 pandemic, have highlighted the need for diversified sourcing strategies.
• Quality & Certification: Stringent qualification processes are essential to prevent counterfeit or substandard APIs.

Conclusion

The suppliers for nelfinavir mesylate comprise a combination of original patent holders, global generic manufacturers, regional suppliers, and CMOs, each playing critical roles in maintaining supply continuity and quality. As the HIV treatment landscape evolves, so do the dynamics of API sourcing, emphasizing the importance of robust qualification practices, regulatory compliance, and diversified supply chains. Stakeholders must continuously monitor regulatory updates, market entries, and manufacturing standards to ensure reliable procurement and patient safety.

Key Takeaways

• Leading global suppliers of nelfinavir mesylate include both original innovators like AbbVie and a growing roster of reputable generics players such as Cipla, Aurobindo, and Hetero.
• Post-patent expiration, the market has experienced increased competition, improving pricing and supply accessibility, especially in resource-limited settings.
• Ensuring supplier compliance with GMP and international regulatory standards remains critical to maintaining drug quality and efficacy.
• Contract manufacturing organizations provide scalable, compliant solutions that expand supply capacity and reduce dependence on a sole source.
• Diversified sourcing and ongoing supplier qualification are essential strategies to mitigate risks associated with global disruptions and regulatory changes.

5 FAQs about Suppliers for Nelfinavir Mesylate

Q1: Are there reputable suppliers of nelfinavir mesylate outside India and the U.S.?
Yes, regional suppliers in China, Vietnam, and Brazil are active, primarily aimed at domestic markets or regional exports. However, due diligence regarding their regulatory compliance and GMP standards is recommended.

Q2: How can buyers verify the quality of nelfinavir mesylate supplied?
Buyers should request Certificates of Analysis (CoA), Batch Production Records, and GMP certificates. Auditing manufacturing facilities and verifying regulatory approvals (FDA, EMA, WHO-GMP) are critical steps.

Q3: Is nelfinavir mesylate available from all current patent holders?
No. Patent rights restrict production exclusively to patent holders or authorized licensees until patent expiration or for regions where patents are not filed. Post-expiration, generic manufacturers can produce and distribute the API.

Q4: What are the key considerations when choosing a supplier for nelfinavir mesylate?
Regulatory compliance, product quality, manufacturing capacity, experience with antiretroviral APIs, and supply chain stability are paramount. Cost and delivery timelines are also critical factors.

Q5: Are there governmental or NGO programs that facilitate sourcing of nelfinavir mesylate?
Yes, organizations such as the Global Fund and UNITAID often work with approved suppliers and manufacturers to ensure the procurement of quality-assured antiretroviral drugs, including nelfinavir mesylate, for low-resource regions.

References

1. U.S. Food and Drug Administration. FDA Drug Approvals and Regulatory Records.
2. World Health Organization. WHO Prequalification of Medicines Programme.
3. Indian Pharmacopoeia Commission. List of approved pharmaceutical manufacturers.
4. Market intelligence reports on antiretroviral drug manufacturing.
5. International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Guidelines on API manufacturing standards.