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01 1Macleods Pharmaceuticals Limited

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PharmaCompass

Looking for Drug Master Files (DMF) for 35800 of Macleods Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 35800 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 TAMSULOSIN HYDROCHLORIDE USP, with a corresponding US DMF Number 35800.

Remarkably, this DMF maintains an Active status since its submission on July 03, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 23, 2022, and payment made on February 24, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II