TAIWAN BIOTECH CO LTD
Overview
TAIWAN BIOTECH CO LTD is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering BISOPROLOL FUMARATE.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances TAIWAN BIOTECH CO 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
TAIWAN BIOTECH CO LTD holds 1 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.
- BISOPROLOL FUMARATEActive2006-12-11
- CEPHALEXINInactive1998-09-01
- 7 - AMINO CEPHALOSPORANIC ACIDInactive1994-06-09
FDA compliance signals
5 FDA enforcement records linked to this company.
- warning_letter2018-06-04
FDA Warning Letter (drug product)
- 4832017-09-11
Representative Number of Batches for Annual Review
- 4832017-09-11
Environmental Monitoring System
- 4832017-09-11
Written program not followed
- 4832017-09-11
Records reviewed annually
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