Torrent Pharmaceuticals

Ahmedabad, Gujarat, India torrentpharma.com

Overview

Torrent Pharmaceuticals is a leading pharmaceutical company based in India, known for its wide-ranging portfolio of generic and branded drugs. The company is committed to producing high-quality healthcare solutions in various therapeutic areas to meet global healthcare needs.

Therapeutic areas

CardiovascularCentral Nervous SystemGastrointestinalAnti-InfectiveDiabetology

API / Drug Master Files

Torrent Pharmaceuticals holds 40 active (45 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.

  • LEVOKETOCONAZOLEActive2025-08-30
  • VERICIGUATActive2024-11-22
  • STIRIPENTOLActive2023-12-29
  • PRUCALOPRIDE SUCCINATEActive2023-06-04
  • ZOLPIDEM TARTRATE USPActive2023-02-23
  • PENCICLOVIRActive2021-10-29
  • ROFLUMILASTActive2021-03-11
  • ALOGLIPTIN BENZOATEActive2020-12-11
  • FEBUXOSTATActive2020-11-02
  • SITAGLIPTIN PHOSPHATE MONOHYDRATE USPActive2018-01-19
  • SILODOSINActive2016-11-15
  • DIMETHYL FUMARATE USPActive2016-09-26
  • RASAGILINE MESYLATEActive2016-06-21
  • ANAGRELIDE HYDROCHLORIDE USPActive2015-07-13
  • GUANFACINE HYDROCHLORIDE USPActive2014-08-04

Showing 15 of 45 Drug Master Files.

FDA compliance signals

11 FDA enforcement records linked to this company.

  • 4832023-05-25

    Investigations of discrepancies, failures

  • 4832023-05-25

    Computer control of master formula records

  • 4832022-09-28

    Investigations of discrepancies, failures

  • 4832022-09-28

    Written record of complaint to include findings, follow-up

  • 4832022-09-28

    Cleaning / Sanitizing / Maintenance

  • warning_letter2019-10-08

    FDA Warning Letter (drug product)

  • 4832018-06-15

    Late submission of an ICSR

  • 4832018-06-15

    Periodic safety report missing ICSR

  • 4832018-06-15

    Failure to develop written procedures

  • recall — Class III2016-04-27

    Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.

  • 4832013-07-26

    Test methods

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