Suppliers and packagers for REYATAZ

REYATAZ

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567	NDA	E.R. Squibb & Sons, L.L.C.	0003-3622-12	30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3622-12)	2003-06-24
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	CAPSULE;ORAL	021567	NDA	E.R. Squibb & Sons, L.L.C.	0003-3631-12	60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3631-12)	2003-06-24
Bristol Myers Squibb	REYATAZ	atazanavir sulfate	POWDER;ORAL	206352	NDA	E.R. Squibb & Sons, L.L.C.	0003-3638-10	30 PACKET in 1 CARTON (0003-3638-10) / 1 POWDER in 1 PACKET	2014-12-19

Pharmaceutical Suppliers for REYATAZ (Atazanavir Sulfate)

Last updated: February 19, 2026

REYATAZ (atazanavir sulfate) is an antiretroviral medication used to treat HIV/AIDS. Its production involves a complex supply chain of raw material suppliers, active pharmaceutical ingredient (API) manufacturers, and formulation and packaging facilities. The intellectual property surrounding REYATAZ is primarily held by Bristol Myers Squibb, the originator company. However, the manufacturing process and its component sourcing are subject to regulatory oversight and can involve multiple entities.

Key API Manufacturers for Atazanavir Sulfate

The synthesis of atazanavir sulfate, the API in REYATAZ, is a multi-step chemical process. The primary API manufacturer for REYATAZ has historically been Bristol Myers Squibb's internal manufacturing or contracted specialized API producers. Post-patent expiry, generic manufacturers enter the market, necessitating their own API sourcing.

• Bristol Myers Squibb: As the originator, Bristol Myers Squibb has historically controlled the API production for REYATAZ. Their internal manufacturing capabilities or contracted manufacturing organizations (CMOs) are critical. Specific facilities involved in API production are often proprietary information, but large pharmaceutical companies typically maintain extensive global manufacturing networks.
• Generic API Manufacturers: Following patent expiries, numerous generic drug manufacturers worldwide seek to produce atazanavir sulfate. These manufacturers often rely on specialized API producers. Identifying specific, publicly disclosed API suppliers for generics can be challenging as these relationships are often B2B and not widely advertised unless through regulatory filings or specific partnership announcements. However, companies with strong expertise in complex organic synthesis for antiretrovirals are likely candidates. Examples of regions with significant API manufacturing capabilities include India and China.

Essential Raw Material Suppliers

The synthesis of atazanavir sulfate requires a range of precursor chemicals and reagents. The purity and consistent quality of these raw materials are paramount to ensuring the final API meets stringent pharmaceutical standards.

• Chemical Synthesis Intermediates: The multi-step synthesis of atazanavir involves several key intermediate compounds. Suppliers of these specialized organic chemicals are crucial. These could include manufacturers of specific amino acids, heterocyclic compounds, or protected functional groups.
  • For instance, the synthesis of atazanavir sulfate involves chiral centers, requiring enantiomerically pure starting materials or stereoselective synthesis steps. Suppliers specializing in chiral building blocks are therefore vital.
• Reagents and Solvents: Standard laboratory and industrial reagents, catalysts, and solvents are used in large quantities during API synthesis.
  • Solvents: Common solvents such as methanol, ethanol, isopropyl alcohol, ethyl acetate, toluene, and dichloromethane are required. Major chemical suppliers like BASF, Dow Chemical, and global distributors often supply these in bulk.
  • Reagents: Catalysts (e.g., palladium catalysts for coupling reactions), acids, bases, and other chemical reagents are sourced from specialized chemical companies.

Formulation and Packaging Suppliers

Once the atazanavir sulfate API is manufactured and certified, it is formulated into the final dosage form (capsules) and packaged.

• Excipient Suppliers: Pharmaceutical excipients are inactive ingredients that are essential for drug formulation. For REYATAZ capsules, these typically include:
  • Fillers/Diluents: Such as microcrystalline cellulose or lactose, used to provide bulk to the formulation.
  • Disintegrants: Such as croscarmellose sodium, to help the capsule break apart in the body.
  • Lubricants: Such as magnesium stearate, to prevent sticking during capsule filling.
  • Capsule Shells: Typically made from gelatin or hypromellose (HPMC) for vegetarian options. Suppliers like Capsugel (part of Lonza) or Qualicaps are prominent in this market.
  • Colorants and Opacifiers: Titanium dioxide and iron oxides are commonly used for capsule coloration and light protection.
• Packaging Material Suppliers: This includes the primary packaging (bottles, blister packs) and secondary packaging (cartons, labels, leaflets).
  • Bottle Manufacturers: Plastic (e.g., HDPE) or glass bottle manufacturers.
  • Blister Pack Suppliers: Companies that produce the plastic films and aluminum foil used in blister packaging.
  • Label and Carton Printers: Specialized printing companies that produce pharmaceutical-grade labels and folding cartons.
  • Leaflet Printers: Manufacturers of patient information leaflets.

Regulatory Landscape and Quality Control

The supply chain for REYATAZ, like all pharmaceuticals, is heavily regulated by health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

• Good Manufacturing Practices (GMP): All suppliers involved in the manufacturing of API, excipients, and the finished drug product must adhere to strict GMP guidelines. This ensures consistent quality, safety, and efficacy.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. These confidential documents detail the manufacturing process, facilities, and quality control procedures for the API. Finished drug product manufacturers reference these DMFs in their marketing applications.
• Supplier Audits: Pharmaceutical companies conduct rigorous audits of their suppliers to ensure compliance with GMP and other quality standards. These audits assess everything from manufacturing processes to quality management systems and supply chain security.

Potential Supply Chain Disruptions and Considerations

The global nature of pharmaceutical supply chains makes them susceptible to various disruptions.

• Geopolitical Instability: Events in regions where key raw materials or APIs are sourced can impact availability.
• Natural Disasters and Pandemics: Such events can disrupt manufacturing operations and logistics.
• Regulatory Changes: New or updated regulations can necessitate changes in manufacturing processes or supplier qualifications.
• Intellectual Property and Litigation: Patent challenges or disputes can affect the market availability of both branded and generic versions, indirectly influencing supplier dynamics. For REYATAZ, the expiry of key patents opened the door for generic competition, leading to a broader base of potential suppliers for both API and finished products.

Atazanavir Sulfate: Patent Expiry and Generic Market Entry

The primary patent for REYATAZ (atazanavir sulfate) has expired in major markets, allowing for the introduction of generic versions. This has broadened the supplier landscape, as multiple generic manufacturers now seek to produce and market atazanavir sulfate.

• US Patent Expiration: Key patents covering atazanavir sulfate expired in the U.S. around 2017-2018, following patent term extensions. This paved the way for Abbreviated New Drug Application (ANDA) approvals for generic products.
• Global Patent Landscape: Similar patent expiries have occurred or are occurring in other key global markets, leading to increased generic competition and a diversification of the supply chain.

This shift from a single-source or limited-source branded product to a multi-source generic market means that pharmaceutical companies (both branded and generic) and potentially contract manufacturers will be sourcing API and excipients from a wider array of qualified vendors.

Key Takeaways

• The supply chain for REYATAZ (atazanavir sulfate) involves specialized API manufacturers, raw material suppliers, and formulation and packaging entities.
• Bristol Myers Squibb, as the originator, has historically been a primary controller of the API source.
• Post-patent expiry, generic manufacturers are now active, necessitating their own API sourcing, often from specialized chemical producers in regions like India and China.
• The consistent quality of precursor chemicals, reagents, solvents, and excipients is critical and subject to stringent regulatory oversight (GMP).
• The global supply chain is vulnerable to geopolitical events, natural disasters, and regulatory shifts, impacting availability and cost.
• The entry of generic atazanavir sulfate has diversified the supplier base for both API and finished product components.

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FAQs

1. Who is the primary API manufacturer for branded REYATAZ? Bristol Myers Squibb, the originator company, has historically been responsible for the API manufacturing, either through internal facilities or contracted specialized manufacturers.

2. What types of raw materials are essential for atazanavir sulfate synthesis? Essential raw materials include specialized chemical intermediates, chiral building blocks, various solvents (e.g., methanol, toluene), reagents (e.g., catalysts), and acids/bases.

3. Which regions are significant for generic atazanavir sulfate API production? Regions with substantial expertise in complex organic synthesis and API manufacturing, such as India and China, are significant for generic atazanavir sulfate production.

4. What are the key excipients used in REYATAZ capsules? Key excipients include fillers/diluents (e.g., microcrystalline cellulose), disintegrants (e.g., croscarmellose sodium), lubricants (e.g., magnesium stearate), and capsule shells (e.g., gelatin or HPMC).

5. How do regulatory bodies ensure the quality of REYATAZ suppliers? Regulatory bodies like the FDA and EMA mandate strict adherence to Good Manufacturing Practices (GMP) and require manufacturers to maintain Drug Master Files (DMFs) for APIs. Pharmaceutical companies also conduct regular supplier audits.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/pharmaceutical-quality-resources/drug-master-files-dmfs [2] European Medicines Agency. (n.d.). Good manufacturing practice (GMP). Retrieved from https://www.ema.europa.eu/en/veterinary-regulatory/research-development/good-manufacturing-practice-gmp [3] Bristol Myers Squibb. (n.d.). Manufacturing. (Information on specific manufacturing sites for individual drugs is proprietary and not publicly detailed). [4] Various generic drug manufacturer ANDA filings with the U.S. Food and Drug Administration. (Specific filings are publicly accessible via FDA's databases but are proprietary to the manufacturers). [5] Capsugel (a Lonza company). (n.d.). Hard Capsules. Retrieved from https://www.lonza.com/capsules (General supplier of capsule shells).