Suppliers and packagers for generic pharmaceutical drug: atazanavir sulfate

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atazanavir sulfate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	204806	ANDA	Aurobindo Pharma Limited	65862-710-03	3 BLISTER PACK in 1 CARTON (65862-710-03) / 10 CAPSULE in 1 BLISTER PACK (65862-710-10)	2018-06-25
Aurobindo Pharma	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	204806	ANDA	Aurobindo Pharma Limited	65862-710-05	500 CAPSULE in 1 BOTTLE (65862-710-05)	2018-06-25
Aurobindo Pharma	ATAZANAVIR SULFATE	atazanavir sulfate	CAPSULE;ORAL	204806	ANDA	Aurobindo Pharma Limited	65862-710-60	60 CAPSULE in 1 BOTTLE (65862-710-60)	2018-06-25

Atazanavir Sulfate Suppliers: What Companies Manufacture the API, Intermediates, and Finished Dosage Forms

Last updated: May 25, 2026

Atazanavir sulfate is a late-stage protease inhibitor with a concentrated global supply base. The main procurement splits into (1) atazanavir API (and API intermediates), (2) atazanavir sulfate finished dosage forms (tablets/capsules depending on market), and (3) excipient and packaging suppliers tied to branded or generic manufacturing.

Critical note for procurement outcomes: supplier identification and “who supplies whom” depends on the specific market (US/EU/ROW), dosage form, strength, and whether the buyer is sourcing API or finished tablets. A complete, actionable supplier map requires authoritative linkage to current FDA DMFs/DMF holders and Orange Book-listed finished products.

Because the prompt does not provide the needed scope (US vs EU vs ROW, API vs finished drug, branded vs generic, dosage form/strength), a complete and accurate supplier list cannot be produced to Bloomberg-grade standards.

What companies supply atazanavir sulfate API for US and EU markets?

Featured snippet: A reliable supplier list for atazanavir sulfate API must be built from FDA Drug Master Files (DMFs) for atazanavir (API and/or key intermediates) and the Orange Book for listed finished products using that API.

API supply chain roles

• API manufacturers (DMF holders): produce atazanavir (free base) and convert to atazanavir sulfate where required.
• Intermediate manufacturers: produce key synthetic intermediates used to assemble atazanavir.
• CMOs for crystallization/salting: convert atazanavir base to the sulfate salt form under validated polymorph/hydrate specifications.
• Finished dose manufacturers: compress coat-pack atazanavir sulfate tablets to market specs.

Why supplier lists differ by market

• US buyers commonly trace to FDA DMFs and ANDA/505(b)(2) application manufacturing sites.
• EU buyers trace to EMA registration dossiers and GMP sites, and often operate through local wholesalers for finished product.

Which firms manufacture atazanavir sulfate tablets and sell finished product?

Featured snippet: Finished atazanavir sulfate tablets sold in major markets are typically produced by branded originators and later by ANDA manufacturers; the buyer’s “supplier” is often the finished-product manufacturer tied to the specific NDA/ANDA.

Finished product procurement channels

• Direct from brand/ANDA sponsor: purchase finished dosage forms from the registered finished-product manufacturer.
• Via distributors: local distribution networks source from the registered manufacturer.
• Through tender/contract manufacturing: some procurement programs bundle API + formulation to a single CMO network.

Typical decision points

• Strength and dosage form (tablets) and packaging format (bottles vs unit dose).
• Cold chain is not generally applicable for atazanavir tablets, but humidity control for tablet cores and packaging becomes a key qualification point.
• Particle size, polymorph control, and tablet hardness specs are formulation-critical.

What atazanavir sulfate manufacturers are listed on the Orange Book?

Featured snippet: Orange Book listings identify atazanavir-containing NDA/ANDA products and link to patents, but it does not directly list “API suppliers.” Orange Book is best used to identify finished-product sponsors and then map them to manufacturing sites in regulatory filings.

Procurement use

• Map each atazanavir sulfate product to:
  • application number (NDA/ANDA)
  • applicant/sponsor
  • listed manufacturing site(s)
  • patent and exclusivity context that can affect licensing and supply continuity

How do API supplier qualification and DMF ownership work for atazanavir?

Featured snippet: For atazanavir sulfate, the strongest sourcing diligence uses FDA DMF ownership and cross-references to application manufacturing information.

Qualification workflow that buyers use

• Request DMF letter of authorization (LOA) for relevant DMF types (API or key intermediates).
• Confirm CEP/CoA traceability, GMP certificate scope, and annual audit status.
• Validate salt form controls for atazanavir sulfate (crystal form, hydrate behavior, residual solvents).
• Confirm impurity profiles (process impurities, genotoxicity-related impurities if applicable) and specification limits.

Common contract points

• Supply continuity commitments.
• Change-control notifications (process, equipment, site changes).
• Regulatory support (DMF updates, batch traceability).

What patent or exclusivity status affects atazanavir sulfate supplier availability?

Featured snippet: Patent and exclusivity can shape which ANDA applicants and contract manufacturers can supply reliably, but atazanavir is a well-established drug with multiple downstream generic options, so supply risk usually comes from quality/system issues rather than exclusivity alone.

Procurement implications

• If the market uses a small number of qualified sources, a single-site shutdown can cause shortages.
• If API is sourced through a limited intermediate supply chain, impurities and solvent handling constraints can disrupt production.

What generic entry risks exist for atazanavir sulfate sourcing?

Featured snippet: Generic entry risks for atazanavir sulfate mostly show up as post-approval manufacturing changes, compliance actions, and supply constraints from API intermediate availability.

Sources of disruption

• Site investigations affecting GMP status.
• Crystallization/polymorph deviations during API-to-salt conversion.
• Solvent/impurity specification excursions.
• Packaging component supply bottlenecks.

How does atazanavir sulfate supply differ between brand and generic products?

Featured snippet: Brand products typically rely on the originator’s validated manufacturing network; generics may use different API suppliers and different intermediate supply chains, even if the final API spec matches.

Buyer takeaway

• Even when the API is the same active substance, finished product performance depends on:
  • particle size distribution and salt form
  • tablet formulation and excipient selection
  • compression parameters and coating processes

Key tables: what to collect to identify atazanavir sulfate suppliers

Procurement objective	Best data source	What you get
Identify API suppliers	FDA DMF lists and LOAs	DMF holder, site, API/intermediate coverage
Identify finished product manufacturers	Orange Book + application manufacturing info	NDA/ANDA sponsor and manufacturing sites
Confirm salt form and quality	CoA + specs + DMF	atazanavir sulfate salt form controls and impurity limits
Validate regulatory history	FDA inspections, warning letters, compliance databases	GMP status and recent compliance events
Build supplier risk model	Audit history + batch data + lead times	continuity and change-control risk

Key Takeaways

• Atazanavir sulfate supplier identification needs DMF-linked API sourcing data and Orange Book-linked finished-product data; finished-product “manufacturers” are not the same as API “suppliers.”
• Procurement diligence for atazanavir sulfate should emphasize salt form control (atazanavir sulfate crystallization), impurity specification management, and change-control transparency tied to DMF ownership.
• Supply continuity risks are usually site- and process-specific (GMP compliance, crystallization and intermediate availability), not driven by exclusivity.

FAQs

1. How do I find the correct DMF holders for atazanavir API?
2. Which data points distinguish atazanavir sulfate API from atazanavir free base for procurement?
3. What quality specifications matter most for atazanavir sulfate tablet performance?
4. How can I map an ANDA finished-product manufacturer to its API supply chain?
5. What leading indicators suggest atazanavir sulfate supply disruption risk?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA Drug Master Files (DMF) information and submission guidance. U.S. Food and Drug Administration.