BRAINTREE LABORATORIES INC
Overview
BRAINTREE LABORATORIES INC is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering TEGOPRAZAN.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances BRAINTREE LABORATORIES INC 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
BRAINTREE LABORATORIES INC holds 1 active (1 total) FDA Type II Drug Master File — 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.
- TEGOPRAZANActive2025-10-06
FDA compliance signals
7 FDA enforcement records linked to this company.
- 4832018-02-28
Composite sample top/middle/bottom
- 4832018-02-28
Complaint Record required information
- 4832014-06-04
Post marketing study status report required information
- 4832014-06-04
Failure to develop written procedures
- 4832013-12-13
Adequate space lacking to prevent mix-ups and contamination
- recall — Class III2013-08-28
Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder
- warning_letter2010-05-10
FDA Warning Letter (drug product)
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