Suppliers and packagers for PRIMAQUINE

PRIMAQUINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	PRIMAQUINE	primaquine phosphate	TABLET;ORAL	008316	NDA	Sanofi-Aventis U.S. LLC	0024-1596-01	100 TABLET, FILM COATED in 1 BOTTLE (0024-1596-01)	2011-04-15

Suppliers and packagers for PRIMAQUINE

Last updated: May 24, 2026

Suppliers for Primaquine (Active Ingredient and Finished Dose): Who Manufactures It and What to Know for Sourcing

Primaquine supply chains split between (1) active pharmaceutical ingredient (API) producers of primaquine base and (2) finished-dose manufacturers distributing US-labeled tablets. In the US, primaquine is marketed as a prescription antimalarial in tablet form (primaquine phosphate salt). Sourcing decisions should be anchored to the specific FDA-listed NDA/ANDA product(s), their labeled strength(s), and the Orange Book patent listings tied to those label holders.

Who supplies primaquine API and finished tablets in the US market?

• Primaquine finished dosage in the US is provided by specific NDA/label holders that list the product in the FDA’s Orange Book and distribute through wholesalers under an FDA-approved application.
• Primaquine API is typically produced by specialized generics/chemical firms and then converted to the finished salt form (primaquine phosphate) by API-to-FDF supply chains.

US market sourcing approach

1. Identify the exact FDA-approved product(s) for primaquine tablets (strength and NDA holder).
2. Pull the product’s listed manufacturers (labeling and FDA submission history) and cross-check FDA supplier disclosures where available.
3. Use Orange Book “Applicant Holder” and “Patent” associations to map legal/competitive status and likely vendor networks.

What is the Orange Book status of primaquine tablets?

Primaquine’s Orange Book listings matter because the Orange Book is tied to US market authorization and patent-expiration timelines for each listed product. For a sourcing decision, Orange Book status determines:

• whether generics are already on the market,
• whether new entrants are limited by patent protections,
• which label holders control current supply under FDA-approved applications.

Practical sourcing signals

• If multiple ANDA products are listed, supply is usually less concentrated and more price-competitive.
• If only one listed product exists, supply risk concentrates in fewer manufacturing sites.

How many companies supply primaquine tablets and how concentrated is supply?

Supply concentration depends on:

• number of FDA-approved label holders for primaquine tablets,
• number of manufacturing sites approved for the product(s),
• whether US supply is fulfilled by one or multiple contract manufacturing organizations (CMOs).

Concentration indicators

• Many ANDA competitors usually means more than one finished-dose manufacturer and parallel procurement options.
• Single or limited label holders usually means fewer approved manufacturing sites and higher procurement friction.

Which manufacturers produce primaquine tablets (finished dose) by label holder?

Finished-dose “supplier” in regulatory terms is the FDA applicant/label holder and the associated manufacturing sites for that application. In procurement workflows, teams usually:

• source from label-holder-controlled finished-dose manufacturers, or
• source through distributors that can deliver lot traceability tied to those applications.

What to map for each company

• NDA/ANDA applicant/holder name
• labeled strength(s) (for dosing alignment)
• dosage form and packaging
• manufacturing site(s) shown in FDA records for the application

What patents or exclusivity affect supplier availability for primaquine?

Even if primaquine is off-patent in many markets globally, US patent listings can still affect:

• which applicants can launch generics,
• whether suppliers face Paragraph IV litigation constraints,
• whether reformulation or method-of-use protections limit certain product variants.

Sourcing impact

• When legal barriers exist, approved supply can stay limited to fewer label holders.
• When barriers are absent, more ANDA supply typically appears and availability improves.

Are there Paragraph IV challenges or generic launch risks for primaquine?

Paragraph IV challenges matter because they can alter:

• which applicants are allowed to launch at risk,
• settlement-driven “authorized generic” timing,
• near-term manufacturing and distribution plans by label holders.

Sourcing risk lens

• If active litigation or a recent settlement exists, supply can tighten temporarily during launch windows or manufacturing transitions.

What are the main primaquine delivery forms suppliers provide?

For sourcing, “primaquine” typically maps to:

• tablets containing primaquine phosphate (the salt form used for oral dosing).
• The key operational attribute is tablet strength and excipient profile for manufacturability and stability.

Procurement priority attributes

• strength and count per bottle
• tablet physical characteristics relevant to fulfillment systems
• storage/handling requirements
• lot release and documentation for quality systems

Which jurisdictions control upstream primaquine API supply?

Primaquine API supply is often regionally distributed depending on:

• chemical synthesis capabilities,
• regulatory inspection history,
• ability to meet ICH stability and impurity specifications.

Supplier mapping strategy for upstream risk

• map API sources by country of manufacture,
• link those sources to finished-dose suppliers through quality agreements,
• track inspection outcomes and batch failures where publicly disclosed.

How does primaquine supplier selection change with quality/regulatory requirements?

Supplier qualification for primaquine is governed by:

• cGMP compliance at API and finished-dose sites,
• impurity control (including related substances typical for primaquine synthesis),
• stability and packaging qualification aligned to tablet shelf-life claims,
• traceability of salt conversion and blending steps.

Operational control points

• API incoming testing scope (identity, assay, impurities)
• process validation at salt formation and tablet compression steps
• deviation and OOS/OOT handling and CAPA effectiveness
• documentation completeness (CoA, CoC, batch record traceability)

Key Takeaways

• “Suppliers for primaquine” should be defined as FDA label holders for finished tablets plus the upstream API producers linked to those applications.
• Orange Book status and associated applicant/holder names determine the current US competitive and legal landscape and, by extension, how many qualified finished-dose suppliers exist.
• For procurement and risk management, map by NDA/ANDA holder, strength, approved manufacturing sites, and patent/Orange Book entries tied to each product.
• Supplier concentration and generic launch activity can materially affect near-term availability and pricing dynamics.

FAQs

1. What is the difference between primaquine base and primaquine phosphate for suppliers?
2. How do I identify the finished-dose manufacturer for a specific primaquine tablet strength in the US?
3. Which Orange Book fields are most relevant for assessing supplier/legal risk for primaquine?
4. Do primaquine supply chains typically include contract manufacturers, and how can that affect lead times?
5. What documentation should be required when qualifying a new primaquine supplier for batch traceability?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. FDA. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
3. FDA. FDA Labeling and Application Data (NDA/ANDA records). https://www.fda.gov/drugs/drug-approvals-and-databases