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List of Drug Master Files (DMF) for 30790 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Divis Laboratories (1)

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01 PREGABALIN (ALTERNATIVE PROCESS) (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
30790
Active
2016-08-01
Complete
2016-12-08
2016-08-18
II
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Looking for Drug Master Files (DMF) for 30790 of Divis Laboratories Ltd

Looking for Drug Master Files (DMF) for 30790 of Divis Laboratories Ltd 1

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Divis Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is PREGABALIN (ALTERNATIVE PROCESS), with a corresponding US DMF Number 30790.

Remarkably, this DMF maintains an Active status since its submission on August 01, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 08, 2016, and payment made on August 18, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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