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01 1Raks Pharma

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PharmaCompass

Looking for Drug Master Files (DMF) for 35185 of Raks Pharma Pvt Ltd

Looking for Drug Master Files (DMF) for 35185 of Raks Pharma Pvt Ltd 1

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Raks Pharma Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.

One of their notable products is CHLORDIAZEPOXIDE HYDROCHLORIDE USP, with a corresponding US DMF Number 35185.

Remarkably, this DMF maintains an Active status since its submission on September 28, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 18, 2020, and payment made on September 24, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II