Part 1, Section B : Product Formula

B1 Batch Manufacturing Formula

A batch formula should be provided that includes a list of all components of the dosage form to be used in the manufacturing process, their amounts on a per batch basis, including overages, and a reference to their quality standards.

  • The actual quantities (g, kg, liters) etc. of ingredient should be stated.
  • Overage: Supporting data and reason for including the overage shall be enclosed.
  • The total number of dosage unit per batch must be stated.

Reference EMA Guideline:
Guideline on Manufacture of the Finished Dosage Form

B1.1 Batch Size

Please state the manufacturing batch size of the product.

B1.2 Batch formula

A) Active Ingredient Overage

  • Active Ingredient Name
  • Salt Form
  • Strength of Active Ingredient (Quantity unit/ dose)
  • Strength Salt-Free
  • Source of Active Ingredient (Animal – e.g. Bovine, Porcine, Ovine or Others/ Plant/ Others)
  • Form of Substance
  • Remarks (if any)
  • Status

 B) Excipient Overage

B2 Attachment of Batch Manufacturing Formula

Please attach the manufacturing formula document.


National Pharmaceutical Regulatory Agency (NPRA)

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

  • Phone: +603-7883 5400




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.

Mobile Web :

Site Last Modified

  • Last Modified: Friday 12 July 2024, 15:24:37.
© Copyright 2023 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA


Main Menu English