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01 1Amoli Organics

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PharmaCompass

Looking for Drug Master Files (DMF) for 34619 of Amoli Organics (a Division Of Umedica Laboratories Pvt Ltd)

Looking for Drug Master Files (DMF) for 34619 of Amoli Organics (a Division Of Umedica Laboratories Pvt Ltd) 1

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Amoli Organics (a Division Of Umedica Laboratories Pvt 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 SUCCINYCHOLINE CHLORIDE DIHYDRATE, with a corresponding US DMF Number 34619.

Remarkably, this DMF maintains an Active status since its submission on February 27, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 13, 2020, and payment made on April 22, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II