TINIDAZOLE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618	NDA	Mission Pharmacal Company	0178-8250-40	40 TABLET, FILM COATED in 1 BOTTLE (0178-8250-40)	2004-05-17
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618	NDA	Mission Pharmacal Company	0178-8500-20	20 TABLET, FILM COATED in 1 BOTTLE (0178-8500-20)	2004-05-17
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618	NDA	Mission Pharmacal Company	0178-8500-60	60 TABLET, FILM COATED in 1 BOTTLE (0178-8500-60)	2004-05-17
Mission Pharma	TINDAMAX	tinidazole	TABLET;ORAL	021618	NDA AUTHORIZED GENERIC	BioComp Pharma, Inc.	44523-450-12	12 TABLET, FILM COATED in 1 BOTTLE (44523-450-12)	2025-03-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: April 23, 2026

Tinidazole is an established antiprotozoal/antibacterial active ingredient with a global supply base spanning China, India, Europe, and the US. Below is a structured supplier view focused on commercially relevant channels: API manufacturers (for drug substance), intermediate producers (where disclosed), and finished dosage suppliers/distributors (where regulatory listings exist).

Scope note: Supplier availability depends on application form (API vs. tablets/capsules), strength, regulatory status (DMF/CEP), and destination market.

Which companies supply tinidazole API?

Commonly sourced tinidazole API is produced by multiple mid- to large-scale chemical/pharma manufacturers. For procurement and regulatory strategy, the key filters are: (1) DMF status (US) or CEP (EU), (2) typical particle spec and impurity profile, and (3) ability to supply in your target grade (pharma vs. non-pharma).

High-probability manufacturer set (by regional footprint and market presence):

China (API manufacturing hubs)

China-based producers supply a large share of global tinidazole API volume and often support multiple export markets through established regulatory documentation packages (DMF/CEP-like dossiers depending on jurisdiction).

India (API and intermediates)

India-based manufacturers typically provide tinidazole API with export documentation and batch traceability for global generics programs. Some also supply intermediates used in tinidazole synthesis.

Europe

European supply is typically smaller-scale and more documentation-driven (CEP/plant release discipline). Availability depends on the specific contract and regulatory package.

US

US supply is often tied to finished dosage rather than broad API public supply, with procurement historically routed through distributors and contract sources.

Procurement action (API): In tenders and supplier qualification, specify:

Form: Tinidazole (API)
Grade: Pharma grade suitable for regulatory filing
Regulatory package: DMF for US or CEP for EU (if required)
Batch CoA: Full impurity panel (not just assay)
Compliance: cGMP manufacture and serialization readiness if required

Which suppliers provide tinidazole finished dosage (tablets) or distribution?

Finished dosage supply depends on the country licensing model and whether you seek:

Commercial brand product (originator or branded generics), or
Private label / contract manufacturing (for local market release), or
Distributor channel (purchase of finished goods for wholesaling).

Typical finished dosage sourcing pattern

Generics manufacturers produce tablets or oral solids for local markets.
Wholesalers/distributors import finished goods where local manufacturing is limited.

For procurement, finished dosage sourcing hinges on:

Strength (commonly 500 mg in many markets, but check local product line)
Dosage form (tablets vs. film-coated tablets)
Packaging (strip count, carton labeling, serialization needs)
Regulatory status in destination market (marketing authorization holder matters)

What procurement specifications should be applied to tinidazole supply?

A supplier bid for tinidazole should align to these standard qualification parameters:

Quality and analytical package (minimum)

Assay: Tinidazole content (pharma grade)
Impurities: Identified and limits set (including any known process-related impurities)
Residual solvents: If applicable
Water content / LOD: According to pharmacopeial method
Sulfated ash / residue on ignition: If required by your monograph
Particle size / polymorph control: If your formulation is sensitive

Documentation (minimum)

CoA for each batch
GMP certificate for the manufacturing site
Regulatory dossier readiness: DMF/CEP where required
Stability program evidence if you manage in-market release for finished dosage

How do API supplier grades typically break down for tinidazole?

Tinidazole is typically offered in one of two commercial tiers:

Regulatory-grade API
- Supported by a formal impurity profile and batch release analytics.
- Common in generics R&D and dossier submission.
Non-dossier grade
- Limited analytical depth and documentation.
- Common in lower-regulatory or non-standard applications.

For regulated pharmaceutical manufacturing, procurement should target regulatory-grade API only with explicit impurity controls and full CoA.

Supply risk and continuity considerations for tinidazole

Tinidazole API supply can be sensitive to:

Intermediate availability (upstream supply of key chemical precursors)
Export documentation cycle (batch release and dossier correspondence)
Regulatory enforcement (site-specific inspection outcomes)

Continuity actions that matter in procurement:

Dual-source with at least one alternative qualified supplier
Require CoA + impurity panel for every incoming batch
Lock lead times contractually and plan for customs release variance

Actionable supplier diligence checklist (API and finished dosage)

API supplier qualification

Confirm manufacturing site is the one inspected/certified
Verify DMF/CEP coverage for the exact product grade
Require batch analytics for at least 3 consecutive lots
Check compliance history and change control (process/impurity shifts)

Finished dosage supplier qualification

Confirm tablet composition and dissolution specs
Verify labeling compliance for destination market
Confirm packaging format matches your distribution plan
Ensure stability data covers your shelf-life and storage condition

Key Takeaways

Tinidazole supply is broadly available through established API manufacturing hubs, especially in China and India, with smaller-scale availability in Europe and US-focused routing via distributors or finished dosage channels.
For regulated use, procurement must lock on regulatory-grade API with full impurity profiling and the appropriate dossier package (DMF/CEP).
Finished dosage supply depends on local marketing authorization and distributor/contract manufacturing capability, not only the underlying API.

FAQs

1) Is tinidazole API widely available globally?

Yes. Tinidazole is an established API with a broad international manufacturing footprint, with multiple suppliers supporting export for pharmaceutical-grade applications.

2) What matters most when buying tinidazole API for regulated products?

The supplier’s impurity panel, batch-to-batch consistency, and regulatory documentation readiness (DMF/CEP where required).

3) Can I source tinidazole tablets from multiple regions?

Yes, but you must match the strength, excipient composition, dissolution behavior, labeling, and local authorization status.

4) What causes supply continuity problems for tinidazole?

Upstream intermediate constraints, batch release documentation delays, and regulatory actions tied to specific manufacturing sites.

5) Should procurement focus on API or finished dosage for early-stage development?

That depends on your filing pathway, but most regulated development starts by locking API quality first, then aligning formulation and finished dosage sourcing to match.

References

[1] European Medicines Agency (EMA). European public assessment reports and manufacturing authorisation documentation. https://www.ema.europa.eu/
[2] FDA. Drug Master File (DMF) and chemical listing resources. https://www.fda.gov/
[3] WHO. International pharmacopoeia monographs and quality guidance. https://www.who.int/teams/regulation-prequalification/quality
[4] US Pharmacopeia (USP). Tinidazole monographs and analytical methods. https://www.uspnf.com/
[5] ECHA. Substance and supply chain information portals. https://echa.europa.eu/

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