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01 1Alkaloids Bioactives Private Limited

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAlkaloids Bioactives: US FDA, TGA & ISO-Certified Pioneers in Plant-Derived APIs, Nutraceuticals & Cosmeceuticals

GDUFA

DMF Review : Complete

Rev. Date : 2020-07-24

Pay. Date : 2020-07-16

DMF Number : 24155

Submission : 2010-09-09

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 24155 of Alkaloids Bioactives Private Ltd

Looking for Drug Master Files (DMF) for 24155 of Alkaloids Bioactives Private Ltd 1

20

Alkaloids Bioactives Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.

They are recognized for Alkaloids Bioactives: US FDA, TGA & ISO-Certified Pioneers in Plant-Derived APIs, Nutraceuticals & Cosmeceuticals

One of their notable products is COLCHICINE USP (REFINED GRADE), with a corresponding US DMF Number 24155.

Remarkably, this DMF maintains an Active status since its submission on September 09, 2010, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 24, 2020, and payment made on July 16, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II