ACS DOBFAR SPA
Overview
ACS DOBFAR SPA is an active pharmaceutical ingredient (API) supplier with 53 active FDA Type II Drug Master Files, covering 7-ZACA- 7-AMINO-3-[2-(5-METBYL-1,3,4-TBIAZOLYDIL)-THIOMETHYL]-3-CEPHEM-4 CARBOXYLIC) ACID; ACID CEFAZOLIN (INTERMEDIATE GRADE); ACID CEFOTETAN; AMIKACIN BASE; AMIKACIN SULFATE; AMPA.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances ACS DOBFAR SPA 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
ACS DOBFAR SPA holds 53 active (78 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.
- CEFTIBUTEN DIHYDRATEActive2025-09-22
- TAZOBACTAM SODIUM STERILEActive2024-08-05
- PIPERACILLIN AND TAZOBACTAM (STERILE BULK)Active2022-10-13
- CEFTAZIDIME FOR INJECTION (STERILE BULK)Active2019-10-24
- PENICILLIN G POTASSIUM STERILEActive2018-06-19
- SODIUM CARBONATE STERILE LYOPHILIZEDActive2016-08-09
- MEROPENEM TRIHYDRATE STERILEActive2016-07-21
- MEROPENEM TRIHYDRATE NON STERILEActive2016-06-10
- ERTAPENEM SODIUMActive2015-04-13
- NAFCILLIN SODIUM FOR INJECTION (STERILE BULK)Active2013-10-08
- CEFEPIME FOR INJECTION (STERILE BULK)Active2011-03-31
- GENTAMICIN SULFATEActive2010-09-21
- AMPAActive2009-12-31
- CEFTAROLINE FOSAMIL STERILE DRUG SUBSTANCEActive2009-10-09
- ARGININE (STERILE BULK)Active2009-06-15
Showing 15 of 78 Drug Master Files.
FDA compliance signals
16 FDA enforcement records linked to this company.
- 4832018-06-19
Procedures for sterile drug products
- warning_letter2017-01-13
FDA Warning Letter (drug product)
- 4832016-01-19
Computer control of master formula records
- 4832016-01-19
Aseptic Processing Area
- 4832016-01-19
Testing Calculations
- 4832016-01-19
Complete test data included in records
- 4832016-01-19
Authority lacking to review records, investigate errors
- 4832016-01-19
Cleaning System
- 4832016-01-19
Test method modification records do not include
- 4832016-01-19
Following/documenting laboratory controls
- 4832016-01-19
Environmental Monitoring System
- 4832016-01-19
Written records kept in individual logs
- 4832016-01-19
Buildings not maintained in good state of repair
- 4832016-01-19
Equipment to control conditions
- 4832016-01-19
Investigations of discrepancies, failures
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