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.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances Wockhardt Limited 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.
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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