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01 1Jubilant Generics

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Looking for Drug Master Files (DMF) for 18803 of Jubilant Biosys Ltd

Looking for Drug Master Files (DMF) for 18803 of Jubilant Biosys Ltd 1

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Jubilant Biosys 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 TRAMADOL HYDROCHLORIDE USP, with a corresponding US DMF Number 18803.

Remarkably, this DMF maintains an Active status since its submission on September 27, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 21, 2013, and payment made on September 12, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II