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01 1J.B.Chemicals & Pharmaceuticals

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PharmaCompass

Looking for Drug Master Files (DMF) for 34986 of Unique Chemicals (a Div Of J B Chemicals And Pharmaceuticals Ltd)

Looking for Drug Master Files (DMF) for 34986 of Unique Chemicals (a Div Of J B Chemicals And Pharmaceuticals Ltd) 1

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Unique Chemicals (a Div Of J B Chemicals And 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 GLIPIZIDE USP, with a corresponding US DMF Number 34986.

Remarkably, this DMF maintains an Active status since its submission on July 02, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 24, 2021, and payment made on July 28, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II