Overview

UNIMARK REMEDIES LTD is an active pharmaceutical ingredient (API) supplier with 39 active FDA Type II Drug Master Files, covering 7-AMINO-3-CHLORO-3-CEPHEM-4-CARBOXYLIC ACID (7ACCA); ALBENDAZOLE USP; ARMODAFINIL; BENAZEPRIL HYDROCHLORIDE USP; BUSPIRONE HYDROCHLORIDE USP; CEFIXIME USP.

Core services & business areas

API Manufacturing

Active pharmaceutical ingredients supplied

Substances UNIMARK REMEDIES LTD 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.

API / Drug Master Files

UNIMARK REMEDIES LTD holds 39 active (52 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.

  • STERILE MIXTURE FOR MEROPENEM AND SODIUM CARBONATE (DRUG PRODUCT INTERMEDIATE)Active2014-06-19
  • STERILE MIXTURE FOR IMIPENEM, CILASTATIN SODIUM AND SODIUM BICARBONATE (DRUG PRODUCT INTERMEDIATE)Active2014-06-18
  • IMIPENEM USP (STERILE)Active2014-06-16
  • CILASTATIN SODIUM USP (STERILE)Active2014-06-12
  • MEROPENEM USP (STERILE)Active2014-06-07
  • CILASTATIN ACID (INTERMEDIATE)Active2014-06-03
  • DORIPENEM STERILEActive2014-05-30
  • IMIPENEM CRUDE (INTERMEDIATE)Active2014-05-23
  • DORIPENEM CRUDE (INTERMEDIATE)Active2014-04-25
  • NITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS)Active2012-06-28
  • CEFIXIME USPActive2012-06-08
  • MEROPENEM TECHNICALActive2012-03-31
  • FEBUXOSTATEActive2012-02-24
  • DRONEDARONE HYDROCHLORIDEActive2012-02-16
  • BUSPIRONE HYDROCHLORIDE USPActive2011-11-16

Showing 15 of 52 Drug Master Files.

FDA compliance signals

3 FDA enforcement records linked to this company.

  • warning_letter2016-08-12

    FDA Warning Letter (drug product)

  • warning_letter2016-08-12

    FDA Warning Letter (drug product)

  • warning_letter2015-09-29

    FDA Warning Letter (drug product)

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