Strides Pharma Science Limited
Overview
Strides Pharma Science Limited is an Indian pharmaceutical company that develops, manufactures, and sells a diversified portfolio of pharmaceutical products with a focus on regulated markets such as the United States, Europe, and Australia. It specializes in the production of both branded and generic medications, with emphasis on generics and anti-retroviral and anti-infective drugs.
Therapeutic areas
FDA compliance signals
16 FDA enforcement records linked to this company.
- 4832023-02-24
Cleaning / Sanitizing / Maintenance
- 4832023-02-24
Computer control of master formula records
- 4832023-02-24
Complete instructions, procedures, specifications et. al.
- 4832023-02-24
Procedures not in writing, fully followed
- 4832023-02-24
Investigations of discrepancies, failures
- recall — Class III2020-03-25
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
- 4832020-01-17
Extent of discrepancy, failure investigations
- warning_letter2019-07-01
FDA Warning Letter (drug product)
- 4832019-05-24
Written record of investigation incomplete
- 4832019-05-24
Extent of discrepancy, failure investigations
- 4832019-05-24
Control procedures to monitor and validate performance
- 4832019-05-24
Scientifically sound laboratory controls
- 4832014-08-26
Investigations of discrepancies, failures
- 4832014-08-26
Complaint Investigation/Follow-Up Findings
- 4832014-08-26
Control procedures to monitor and validate performance
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