SHARON BIO MEDICINE LTD
Overview
SHARON BIO MEDICINE LTD is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering KETOCONAZOLE USP; MEMANTINE HYDROCHLORIDE; MOXIFLOXACIN HYDROCHLORIDE USP; NIFEDIPINE USP; TELMISARTAN USP.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances SHARON BIO MEDICINE 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
SHARON BIO MEDICINE LTD holds 5 active (5 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.
- TELMISARTAN USPActive2012-05-28
- MOXIFLOXACIN HYDROCHLORIDE USPActive2012-03-30
- NIFEDIPINE USPActive2011-12-05
- MEMANTINE HYDROCHLORIDEActive2011-08-09
- KETOCONAZOLE USPActive2011-06-07
FDA compliance signals
1 FDA enforcement record linked to this company.
- warning_letter2015-06-22
FDA Warning Letter (drug product)
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