Second Source and Replacement Products

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Second Source and Replacement Products (Effective August 2019)

  • All second source and replacement New Drug Product (NDP) products will be evaluated at NDP Section.
  • Requirement & fee will follow NDP.
  • Timeline: 210 working days.

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email:
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075


The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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Site Last Modified

  • Last Modified: Friday 15 October 2021, 15:58:04.
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