Last updated: June 2, 2026
Tindamax (tinidazole) suppliers: who makes the active ingredient and finished dose?
Executive summary: Tindamax is a branded tinidazole product (nitroimidazole). In the US supply chain, the key supplier category is tinidazole API manufacturers and finished-dose (FDF) contract manufacturers / packagers that produce generic tinidazole tablets and capsules. However, no reliable, complete supplier roster by company name can be produced from the information provided here.
What companies supply tinidazole API for Tindamax and tinidazole generics?
Tinidazole supply is typically split into:
- API producers (manufacture tinidazole bulk drug substance)
- FDF producers (tablets/capsules for branded or generic labels)
- Packaging and distribution suppliers (secondary packaging, label printing, wholesaling)
Supplier mapping that is specific to “Tindamax” is not determinable without identifiable data tying:
- the brand’s US labeler (listed in FDA databases),
- the manufacturer(s) for the specific dosage form/strength,
- and the API source and site-level production records.
Are there multiple API sources or is supply concentrated?
Tinidazole is a mature small molecule and is commonly supported by multiple generic supply chains, but the actual number of qualified API suppliers for the US market depends on the FDA-approved application landscape and commercial arrangements, which are not included in the input.
Who manufactures the Tindamax finished tablets or capsules (contract manufacturing and labelers)?
For a branded drug like Tindamax, the supplier picture usually centers on:
- the FDA “labeler” (application holder / distributor),
- the listed manufacturing site(s) (drug product, packaging),
- and the approved manufacturer(s) for each strength.
Those details are typically retrievable from the FDA’s drug listing and Orange Book records, but they are not present in the provided information, so a company-level list cannot be stated.
Which dosage forms and strengths affect supplier selection?
Tinidazole is marketed in multiple strengths and presentations across markets. Supplier selection can differ by:
- tablet vs capsule
- strength (for example, 250 mg vs 500 mg, depending on label)
- packaging configuration
Without the specific Tindamax NDC/strength you mean, a supplier-by-strength mapping cannot be completed.
What does the Orange Book show about Tindamax manufacturing and patent-linked supplier risks?
Orange Book typically links:
- active ingredient
- dosage form
- approved application(s)
- patent and exclusivity status
But supplier names are not the same as patent holders. Determining “who supplies Tindamax” requires linking:
- application holder(s) and manufacturing site(s),
- and then tracing upstream API sources.
No Orange Book application or NDC/labeler data is included in the input, so no definitive supplier roster can be produced.
Which generic tinidazole manufacturers are active in the US and likely to be supply sources?
In practice, generic tinidazole tablet and capsule supply often comes from multiple manufacturers across:
- FDA-approved abbreviated applications (ANDA holders)
- contract manufacturing networks
However, generating a ranked list of active generic manufacturers requires:
- access to FDA NDC listings,
- ANDA application records,
- and product-level manufacturer site data.
That dataset is not provided here, so no company list can be stated.
What supplier categories matter for procurement of tinidazole (API vs FDF vs packaging)?
Even without company names, procurement due diligence for tinidazole generally focuses on:
- API quality system (GMP status)
- impurity profile control and nitroimidazole impurity specifications
- particle size and tablet/capsule compatibility (if supplying FDF)
- compliance for nitrosamine risk controls (where applicable)
- cold chain is usually not required for tinidazole, but moisture control can matter for certain solid dosage forms
A supplier list still requires the missing labeler/NDC data.
How to validate a claimed tinidazole supplier for Tindamax: what documents to request
A defensible supplier validation package usually includes:
- GMP certificate for the manufacturing site
- CoA for recent batches and specification sheets
- audit report summary or supplier qualification SOP excerpt
- validation/qualification for cleaning and cross-contamination controls
- change control history and CAPA summaries
- batch manufacturing record excerpts where permitted
- regulatory correspondence (inspection outcomes, if any)
Company-specific supplier identification cannot be completed from the input.
Key Takeaways
- Tindamax is tinidazole; supplier determination requires labeler, NDC, and site-level manufacturing data.
- The input provided does not include those identifiers or regulatory listings, so a complete and accurate named supplier list cannot be produced.
FAQs
- Is tinidazole API supply concentrated among a few manufacturers?
- Do the same companies that supply tinidazole API also manufacture finished tablets?
- How do I confirm the GMP manufacturing site for a tinidazole product by NDC?
- What quality risks are most important when sourcing nitroimidazole APIs?
- Can Orange Book listings be used to identify upstream API suppliers?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- FDA. Drugs@FDA.
