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01 1Unichem Laboratories Limited

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PharmaCompass

Looking for Drug Master Files (DMF) for 16278 of Unichem Laboratories Ltd

Looking for Drug Master Files (DMF) for 16278 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 HYDROCHLOROTHIAZIDE USP, with a corresponding US DMF Number 16278.

Remarkably, this DMF maintains an Active status since its submission on November 26, 2002, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 30, 2013, and payment made on April 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II