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List of Drug Master Files (DMF) for 29737 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Zydus Lifesciences (1)

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01 CINACALCET HYDROCHLORIDE (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
29737
Active
2015-10-06
Complete
2015-12-04
2015-09-16
II
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Looking for Drug Master Files (DMF) for 29737 of Zydus Lifesciences Ltd

Looking for Drug Master Files (DMF) for 29737 of Zydus Lifesciences Ltd 1

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Zydus Lifesciences 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 CINACALCET HYDROCHLORIDE, with a corresponding US DMF Number 29737.

Remarkably, this DMF maintains an Active status since its submission on October 06, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 04, 2015, and payment made on September 16, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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