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01 1Alkaloids Private Limited

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAlkaloids Private Limited: WHO-GMP, USFDA, EU-GMP & ISO compliant phyto and synthetic APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2015-10-06

Pay. Date : 2015-03-25

DMF Number : 28629

Submission : 2014-09-08

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 28629 of Alkaloids Private Ltd

Looking for Drug Master Files (DMF) for 28629 of Alkaloids Private Ltd 1

20

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

They are recognized for Alkaloids Private Limited: WHO-GMP, USFDA, EU-GMP & ISO compliant phyto and synthetic APIs.

One of their notable products is METHSCOPOLAMINE BROMIDE, with a corresponding US DMF Number 28629.

Remarkably, this DMF maintains an Active status since its submission on September 08, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 06, 2015, and payment made on March 25, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II