Section B New Chemical Entity

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

*Batch Manufacturing Record (plant document)

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

Please attach the batch manufacturing formula document.