VALENS MOLECULES PRIVATE LTD
Overview
VALENS MOLECULES PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering HYDROCHLOROTHIAZIDE USP; PHENAZOPYRIDINE DC PVP; PHENAZOPYRIDINE HYDROCHLORIDE USP; SULFASALAZINE USP.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances VALENS MOLECULES 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
VALENS MOLECULES PRIVATE LTD holds 4 active (4 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.
- SULFASALAZINE USPActive2012-06-05
- PHENAZOPYRIDINE HYDROCHLORIDE USPActive2008-01-28
- PHENAZOPYRIDINE DC PVPActive2008-01-28
- HYDROCHLOROTHIAZIDE USPActive2006-08-31
FDA compliance signals
2 FDA enforcement records linked to this company.
- 4832024-11-15
Calibration/Inspection/Checking not done
- warning_letter2013-08-02
FDA Warning Letter (drug product)
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