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01 1Macleods Pharmaceuticals Limited

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PharmaCompass

Looking for Drug Master Files (DMF) for 31301 of Macleods Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 31301 of Macleods Pharmaceuticals Ltd 1

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Macleods Pharmaceuticals 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 DOLUTEGRAVIR SODIUM, with a corresponding US DMF Number 31301.

Remarkably, this DMF maintains an Active status since its submission on January 18, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 02, 2017, and payment made on February 09, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II