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01 1Ind Swift Laboratories Limited

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Looking for Drug Master Files (DMF) for 16518 of Synthimed Labs Private Ltd

Looking for Drug Master Files (DMF) for 16518 of Synthimed Labs Private Ltd 1

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Synthimed Labs Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from EDQM and WHO-GMP.

One of their notable products is CLARITHROMYCIN, with a corresponding US DMF Number 16518.

Remarkably, this DMF maintains an Active status since its submission on April 08, 2003, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 30, 2013, and payment made on December 26, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II