SYNTHOKEM LABS PRIVATE LTD
Overview
SYNTHOKEM LABS PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 25 active FDA Type II Drug Master Files, covering ACAMPROSATE CALCIUM USP; ANASTROZOLE USP; ATORVASTATIN CALCIUM USP; BEMPEDOIC ACID; CINACALCET HYDROCHLORIDE; CLARITHROMYCIN.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances SYNTHOKEM LABS PRIVATE LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
SYNTHOKEM LABS PRIVATE LTD holds 3 active (3 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- PRAZOSIN HYDROCHLORIDEActive2024-01-03
- METHOCARBAMOL USPActive1993-08-13
- GUAIFENESIN USPActive1993-08-13
FDA compliance signals
No FDA recalls, Warning Letters, or Form 483 observations are linked to SYNTHOKEM LABS PRIVATE LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.
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