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01 1Macleods Pharmaceuticals Limited

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Looking for Drug Master Files (DMF) for 26317 of Macleods Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 26317 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 PREGABALIN USP, with a corresponding US DMF Number 26317.

Remarkably, this DMF maintains an Active status since its submission on August 27, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 08, 2014, and payment made on July 10, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II