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List of Drug Master Files (DMF) for 13948 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Embio Limited (1)

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01 PSEUDOEPHEDRINE HYDROCHLORIDE, USP (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
13948
Active
1998-12-29
Complete
2013-03-17
2013-03-11
II
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Looking for Drug Master Files (DMF) for 13948 of Embio Ltd

Looking for Drug Master Files (DMF) for 13948 of Embio Ltd 1

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Embio Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is PSEUDOEPHEDRINE HYDROCHLORIDE, USP, with a corresponding US DMF Number 13948.

Remarkably, this DMF maintains an Active status since its submission on December 29, 1998, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 17, 2013, and payment made on March 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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