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Template and Declaration Letter for API

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Document Name Download Updated
Declaration Letter for an Approved API in New Product Registration Application Dec-19
Declaration on GMP of API Intermediate Aug-18
Declaration on Quality of Atypical API (Letter_AAPI_V1) Oct-19
Template Cover Letter for DMF Submission Dec-19

 

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National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

 

 

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