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List of Drug Master Files (DMF) for 19195 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Solara Active Pharma Sciences (1)

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01 MEFENAMIC ACID, 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
19195
Active
2006-02-23
Complete
2016-08-15
2016-03-21
II
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Looking for Drug Master Files (DMF) for 19195 of Solara Active Pharma Sciences Ltd

Looking for Drug Master Files (DMF) for 19195 of Solara Active Pharma Sciences Ltd 1

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Solara Active Pharma Sciences Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.

They are recognized for API Expertise for more than 30 Years, with 4 Manufacturing Facilities armed with Global Approvals.

One of their notable products is MEFENAMIC ACID, USP, with a corresponding US DMF Number 19195.

Remarkably, this DMF maintains an Active status since its submission on February 23, 2006, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 15, 2016, and payment made on March 21, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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