Because of the specification of Pioglitazone HCl (drug substance of Actosmet 2B 2/55 (N) - IPML and 2B 2/51 (N) – Thai Meiji) and also Drug Product specification have not indicated the related substance name I, II and III so, we would like to indicate the name of them in the specification of locally repacked license as explained in attached declaration letter.
Please find enclosed the proposed specification and supportive documents for FDA submission.
1. Proposed Actosmet specification
2. Current Actosmet specification
3. Proposed Pioglitazone HCl specification
4. Current Pioglitazone HCl specification
5. Supportive documents:
a. USP 37 – Pioglitazone
b. Related substance chemical name – It is the registered document in section 3.2.S.4.3.
c. Declaration letter (original letter will be sent to you by messenger)
This variation will impact to Actosmet produced from Takeda Pharmaceutical, Japan only and there is no update in specification of import product.
Please kindly submit to FDA by Feb-2015 and keep me inform