List of Drug Master Files (DMF) for 28938 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Question

Looking for Drug Master Files (DMF) for 28938 of Msn Organics Private Ltd

score 20 · Accepted Answer

Msn Organics Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is TICAGRELOR (FORM-II) [ROUTE CODE "TG2"], with a corresponding US DMF Number 28938.

Remarkably, this DMF maintains an Active status since its submission on January 27, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 03, 2015, and payment made on January 06, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

List of Drug Master Files (DMF) for 28938 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Looking for Drug Master Files (DMF) for 28938 of Msn Organics Private Ltd