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List of Drug Master Files (DMF) for 20539 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 CETIRIZINE HYDROCHLORIDE DIHYDROCHLORIDE 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
20539
Active
2007-05-17
Complete
2013-02-07
2013-01-24
II
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Looking for Drug Master Files (DMF) for 20539 of Solara Active Pharma Sciences Ltd

Looking for Drug Master Files (DMF) for 20539 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 CETIRIZINE HYDROCHLORIDE DIHYDROCHLORIDE USP, with a corresponding US DMF Number 20539.

Remarkably, this DMF maintains an Active status since its submission on May 17, 2007, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 07, 2013, and payment made on January 24, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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