Aurobindo Pharma Limited
Overview
Aurobindo Pharma Limited is a leading pharmaceutical company headquartered in India. It specializes in the development, manufacture, and sale of generic pharmaceutical formulations and active pharmaceutical ingredients. The company is known for its wide range of therapeutic offerings and global reach.
Therapeutic areas
API / Drug Master Files
Aurobindo Pharma Limited holds 0 active (28 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.
- CLINDAMYCIN HYDROCHLORIDE USPInactive2012-04-02
- CANDESARTAN CILEXETIL (NON STERILE DRUG SUBSTANCE)Inactive2010-11-04
- FLUVASTATIN SODIUM USP (NON-STERILE DRUG SUBSTANCE)Inactive2010-04-08
- VALSARTAN USP (NON-STERILE DRUG SUBSTANCE)Inactive2008-07-30
- CEFOXITIN SODIUM USP (STERILE BULK)Inactive2008-01-31
- GLYCOPYRROLATE USP, NON-STERILE DRUG SUBSTANCEInactive2007-07-31
- CEFOXITIN ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE)Inactive2007-02-19
- AMOXICILLIN SODIUM (STERILE) BULKInactive2006-12-30
- CEFTAZIDIME FOR INJECTION USP (STERILE BULK)Inactive2006-11-17
- CEPHALOTHIN ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE)Inactive2006-11-16
- INDINAVIR SULFATE USP (NON-STERILE DRUG SUBSTANCE)Inactive2006-10-06
- CEFEPIME FOR INJECTION USP (STERILE BULK)Inactive2006-09-07
- CEFTAZIDIME DIHYDROCHLORIDE, NON-STERILE DRUG SUBSTANCE INTERMEDIATEInactive2006-07-28
- CEFACLOR USPInactive2006-07-26
- CEFEPIME HYDROCHLORIDE, NON-STERILE INTERMEDIATE DRUG SUBSTANCEInactive2006-05-26
Showing 15 of 28 Drug Master Files.
FDA compliance signals
50 FDA enforcement records linked to this company.
- recall — Class II2025-06-25
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
- recall — Class II2024-12-25
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
- recall — Class II2024-12-11
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- recall — Class II2024-12-11
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- recall — Class II2024-12-11
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- recall — Class I2024-08-28
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
- 4832024-05-15
Systems in place to comply with verification requirements
- 4832024-05-15
Notify FDA and immediate trading partners of illegitimate product
- recall — Class II2024-05-15
Discoloration: Dotted and yellow spots on tablets
- recall — Class II2024-05-15
Discoloration: Dotted and yellow spots on tablets
- 4832023-09-29
Control procedures to monitor and validate performance
- recall — Class II2023-09-27
Failed dissolution specifications - results obtained were below spec average.
- recall — Class II2023-08-30
cGMP deviations: Batch was released prior to approval.
- recall — Class II2023-08-30
cGMP deviations: Batch was released prior to approval.
- 4832023-07-21
Written procedures not established/followed
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