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Update of Guidance Notes for API Information for Product Registration - Version 3.0 (October 2019)

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This is to inform that there has been an update on the Guidance Notes for Active Pharmaceutical Ingredient (API) information required for product registration.

The summary of changes is outlined below:

Please click Download for Version 3.0 of Guidance Notes

 

 

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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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