Suppliers and packagers for generic pharmaceutical drug: TIOPRONIN

TIOPRONIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843	NDA	Mission Pharmacal Company	0178-0901-90	90 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0901-90)	2019-06-28
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843	NDA	Mission Pharmacal Company	0178-0902-01	300 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0902-01)	2019-06-28
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843	NDA AUTHORIZED GENERIC	BioComp Pharma, Inc.	44523-054-01	300 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-054-01)	2024-12-05
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843	NDA AUTHORIZED GENERIC	BioComp Pharma, Inc.	44523-055-01	90 TABLET, DELAYED RELEASE in 1 BOTTLE (44523-055-01)	2024-12-05
Amneal	TIOPRONIN	tiopronin	TABLET, DELAYED RELEASE;ORAL	216278	ANDA	Amneal Pharmaceuticals NY LLC	60219-2009-9	90 TABLET, DELAYED RELEASE in 1 BOTTLE (60219-2009-9)	2025-01-02
Ph Health	TIOPRONIN	tiopronin	TABLET, DELAYED RELEASE;ORAL	217219	ANDA	Endo USA, Inc.	0254-3034-30	300 TABLET, DELAYED RELEASE in 1 BOTTLE (0254-3034-30)	2024-06-26

Suppliers and packagers for generic pharmaceutical drug: TIOPRONIN

Last updated: April 26, 2026

Who Supplies TIOPRONIN (Thiotriazinone / Tiopronin) for Pharma Use?

Which companies supply tiopronin as an API or intermediate?

Tiopronin sourcing is typically split between (a) API manufacturers that can support GMP commercial supply and (b) chemical producers that supply tiopronin from synthetic routes and then resell via trading channels. Public procurement data for tiopronin is fragmented by geography and customer qualification status, so the most decision-useful view is by category and the supplier types that reliably carry tiopronin for pharmaceutical commercialization.

Primary supplier archetypes

• GMP API manufacturers (sell tiopronin finished API with documentation for regulated markets)
• Specialty chemical manufacturers (sell tiopronin as bulk chemical that may or may not be qualified for direct pharma use)
• Distributors/traders (repackage bulk API and provide documentation, often with multiple upstream sources)

What supplier list is actionable for procurement?

No complete, verifiable supplier roster for “tiopronin” can be produced from the information provided. A procurement-grade answer requires confirmed identities tied to tiopronin API or pharma-grade supply (company name, site, and product form such as API vs. bulk), and that cannot be established from the prompt alone.

Key Takeaways

• Tiopronin supply is typically handled through GMP API manufacturers plus distributors that route supply from upstream producers.
• A decision-ready supplier list cannot be generated without verifiable supplier identity data tied specifically to tiopronin pharmaceutical supply.

FAQs

1. Is tiopronin usually sourced as an API or as a bulk chemical?
   It is commonly sourced either as a GMP API (preferred for regulated manufacture) or as bulk chemical via intermediaries depending on end use.

2. Do all tiopronin chemical producers supply pharmaceutical-grade API?
   No. Chemical producers may sell bulk material without GMP-compliant regulatory documentation.

3. What matters most when selecting a tiopronin supplier?
   GMP status for the specific site, documentation package (CoA/CoC, impurity profile), and the ability to support regulatory qualification in the target market.

4. Can distributors provide the same quality as manufacturers?
   Distributors can, but only when they provide traceable upstream sourcing and the required pharma documentation for the exact batch.

5. How do buyers typically reduce supply risk for tiopronin?
   Qualify at least two supply sources and require batch-level traceability and consistent impurity specifications.

References

[1] No external sources were provided in the prompt.