Last updated: April 24, 2026
Who supplies griseofulvin for pharmaceuticals?
Which companies supply griseofulvin API and/or drug product?
Griseofulvin is sourced through multiple commercial channels, but supplier visibility varies by jurisdiction, dosage form, and whether the item is supplied as API, intermediate, or finished dosage.
Commercial supplier set (commonly listed in trade and distribution channels):
- HiMedia Laboratories (India)
- Alkem Laboratories (India)
- Mylan / Viatris (legacy generics distribution; product-level availability depends on market)
- Teva (legacy generics distribution; product-level availability depends on market)
- Teligent/Watson legacy channels (finished product distribution depends on market history)
API and chemical-grade sourcing channels (typical for griseofulvin):
- China-based specialty chemical manufacturers that list griseofulvin in catalog form and supply into finished-dose and compounding markets (supplier identity depends on exact grade, e.g., USP/EP, and on regulatory status in the destination country).
- Indian API/chemical distributors that resell griseofulvin to local finished-dose manufacturers and wholesalers.
Practical implication for procurement:
The most reliable match comes from procurement via licensed distributors (finished-dose) or qualified API manufacturers (API) who can provide documentation by destination: CEP/DMF where applicable, CoA, batch release, and compliance statements. Supplier identity changes by territory.
What are the key sourcing checkpoints for griseofulvin?
Griseofulvin is often purchased as either:
- API (raw material grade for formulators)
- Finished dosage (tablet formulations for end markets)
To reduce supply risk, qualification should require:
- Grade alignment (USP, BP/EP, or local pharmacopoeia claim)
- Regulatory documentation (DMF/CEP where applicable to destination)
- GMP status (manufacturer audit evidence)
- Analytical CoA controls (identity, assay, related substances, particle size if relevant, microbial limits if stated)
- Formulation constraints (crystalline form and bioavailability considerations for tablets)
Where does griseofulvin typically sit in the supply chain?
- API manufacturers and resellers supply raw material to finished-dose manufacturers
- Finished-dose manufacturers distribute to wholesalers by country
- Importers handle local registration and batch release
Because griseofulvin is an older molecule, supply often concentrates in:
- legacy generic product portfolios
- specialty antifungal supply chains
- regional distributors with established low-volume inventory
What determines which supplier can be used in a specific market?
Supplier eligibility is usually driven by:
- Local registration status (whether the finished product is authorized)
- Whether the target is API or dosage (different supplier universe)
- Pharmacopoeia grade and documentation package
- Batch release requirements for the destination country
Which categories of suppliers matter most for operational procurement?
- Licensed finished-dose distributors (if you buy tablets/suspension)
- Qualified API manufacturers (if you formulate or compound)
- Lab/chemical catalog suppliers (often not ideal for regulated manufacturing unless they support GMP and full regulatory artifacts)
Key Takeaways
- Griseofulvin sourcing typically runs through licensed distributor channels for finished dosage and API manufacturer or qualified reseller channels for bulk.
- Supplier identity depends on whether procurement targets API versus finished tablets and on destination regulatory status.
- Qualification should focus on grade, GMP/DMF/CEP documentation, CoA controls, and batch release alignment.
FAQs
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Is griseofulvin usually sourced as API or finished dosage?
Both are available; API is used by formulators, while finished dosage is distributed for direct market use.
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Do the same companies supply both griseofulvin API and finished tablets?
No. API suppliers and finished-dose distributors/manufacturers are often different entities.
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What documents should a griseofulvin supplier provide for regulated supply?
CoA per batch and regulatory artifacts aligned to destination (for example DMF/CEP where applicable), plus GMP evidence.
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Does pharmacopoeia grade affect supplier selection?
Yes. Suppliers must match USP/EP/BP or local grade claims and analytical specifications.
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How stable is griseofulvin supply compared with newer antifungals?
It is typically more dependent on regional generic portfolios and inventory planning, which can shift supplier availability by market.
References
[1] HiMedia Laboratories. Griseofulvin product information.
[2] USP-NF. Griseofulvin monograph and specifications (USP).
[3] European Directorate for the Quality of Medicines (EDQM). CEP database search for griseofulvin (if applicable).
[4] Pharmacopoeial Forum. Harmonization notes and monograph references for griseofulvin (as applicable).
