Recommendation for batch size for solution/ granule for suspension dosage form


(dushyant) #1

Batch size recommendation as abbreviated new drug applications.

As we know for oral dosage form except orphan drug.

Oral dosage form

Two of the three batches should be of at least 10 percent of the proposed production batch or 100,000 finished dosage units, whichever is greater (i.e., pilot scale batches). The third batch can be smaller than the 10 percent of the proposed production batch, but should not be less than 25 percent of the pilot scale batch. We recommend stability data be generated for the three ANDA submission batches in the proposed marketing container. A minimum of 100,000 units in all proposed presentations is recommended.

Can any one share their view on “recommendation for batch size for solution/ granule for suspension dosage from”?


(Vipul Patil) #2

Hey Dushyant Thanks for this info… I m from marketing site. Could you pls recommend me any book which will help me understand all such production related details which helps great deal in discussion with customer…


(dushyant) #3

There is no single book available for such information…All guidance/ technical reccomondation updated day by day through regulatory body