FAQ
Drugs

What are the requirements for the batch size of the batch manufacturing record (BMR) which is submitted for an ANDA?

刊登日期:2019-11-13  |  點閱次數 : 1367 次 

In principle, a pilot scale which is representative of a full production scale is acceptable. For solid oral dosage forms, it is generally, at a minimum, one-tenth that of a full production scale or 100,000 dosage units, whichever is the larger. In case of a production batch manufactured at a scale of less than 100,000 dosage units, the production scale can be used as the manufacturing scale.

 

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