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01 1Unichem Laboratories Limited

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PharmaCompass

Looking for Drug Master Files (DMF) for 28934 of Unichem Laboratories Ltd

Looking for Drug Master Files (DMF) for 28934 of Unichem Laboratories Ltd 1

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Unichem 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 NATEGLINIDE (FORM-H) USP, with a corresponding US DMF Number 28934.

Remarkably, this DMF maintains an Active status since its submission on January 05, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 23, 2015, and payment made on December 31, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II