Wockhardt Limited
Overview
Wockhardt Limited is a global pharmaceutical and biotechnology company headquartered in India. It focuses on the production and marketing of pharmaceuticals and biopharmaceutical formulations and active pharmaceutical ingredients (APIs). Wockhardt is a leader in biotechnology manufacturing and research and development.
API / Drug Master Files
Wockhardt Limited holds 30 active (65 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.
- DESVENLAFAXINE SUCCINATE MONOHYDRATEActive2012-01-13
- PRAMIPEXOLE DIHYDROCHLORIDE USPActive2011-06-23
- CHLOROTHIAZIDE SODIUMActive2009-02-27
- ESZOPICLONEActive2008-11-03
- DONEPEZIL HYDROCHLORIDEActive2008-08-29
- DULOXETINE HYDROCHLORIDE USPActive2008-04-29
- LANSOPRAZOLE USPActive2008-04-23
- NICARDIPINE HYDROCHLORIDEActive2007-12-31
- EPINEPHRINE USPActive2007-12-31
- ZOLEDRONIC ACID MONOHYDRATEActive2007-10-31
- VALACYCLOVIR HYDROCHLORIDEActive2007-10-26
- PANTOPRAZOLE SODIUM USPActive2007-07-31
- ADENOSINE USPActive2007-05-15
- ALFUZOSIN HYDROCHLORIDEActive2007-04-06
- TAMSULOSIN HYDROCHLORIDEActive2006-12-23
Showing 15 of 65 Drug Master Files.
FDA compliance signals
50 FDA enforcement records linked to this company.
- 4832024-06-06
Failure to develop written procedures
- 4832024-06-06
Timely submission
- 4832024-06-06
Late submission of annual safety reports
- recall — Class III2018-07-18
Failed Impurities/Degradation Specifications
- recall — Class III2018-07-18
Failed Impurities/Degradation Specifications
- recall — Class III2017-11-01
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
- warning_letter2016-12-23
FDA Warning Letter (drug product)
- recall — Class II2015-08-26
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
- recall — Class II2015-08-26
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
- recall — Class II2015-07-29
CGMP Deviations: Firm did not adequately investigate customer complaints.
- recall — Class II2015-07-29
CGMP Deviations: Firm did not adequately investigate customer complaints.
- recall — Class II2015-07-29
CGMP Deviations: Firm did not adequately investigate customer complaints.
- recall — Class II2015-07-29
CGMP Deviations: Firm did not adequately investigate customer complaints.
- recall — Class II2015-07-29
CGMP Deviations: Firm did not adequately investigate customer complaints.
- recall — Class II2015-07-29
CGMP Deviations: Firm did not adequately investigate customer complaints.
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