Overview

Aesica Pharmaceuticals Limited is a leading contract development and manufacturing organization (CDMO) that provides extensive pharmaceutical services ranging from drug development to finished product manufacturing. It is a subsidiary of Recipharm AB, a global CDMO headquartered in Sweden.

Therapeutic areas

API / Drug Master Files

Aesica Pharmaceuticals Limited holds 0 active (2 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.

  • PAROXETINE HYDROCHLORIDE HEMIHYDRATEInactive2011-05-05
  • PAROXETINE HYDROCHLORIDEInactive2000-06-01

FDA compliance signals

2 FDA enforcement records linked to this company.

  • 4832014-06-20

    Investigations of discrepancies, failures

  • 4832014-06-20

    Absence of Written Procedures

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