Acrotech Biopharma, Inc.
Overview
Acrotech Biopharma, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies for serious diseases. It operates as a subsidiary of Aurobindo Pharma, a global pharmaceutical manufacturer. The company specializes in oncology and other therapeutic areas to address unmet medical needs.
Therapeutic areas
API / Drug Master Files
Acrotech Biopharma, 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.
- BELINOSTAT DRUG SUBSTANCEActive2013-09-27
FDA compliance signals
6 FDA enforcement records linked to this company.
- 4832024-11-18
Failure to submit scientific article
- 4832024-11-18
Late submission of 15-day report
- 4832024-11-18
Failure to develop written procedures
- 4832023-01-19
Late submission of 15-day report
- 4832023-01-19
Failure to submit scientific article
- 4832023-01-19
Failure to investigate serious, unexpected events
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