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01 1Hetero Drugs

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Looking for Drug Master Files (DMF) for 26178 of Hetero Drugs Ltd

Looking for Drug Master Files (DMF) for 26178 of Hetero Drugs Ltd 1

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Hetero Drugs 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 RITONAVIR PREMIX AMORPHOUS, with a corresponding US DMF Number 26178.

Remarkably, this DMF maintains an Active status since its submission on June 22, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 28, 2014, and payment made on January 04, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II