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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 : 2016-01-05

Pay. Date : 2015-03-25

DMF Number : 28985

Submission : 2015-01-02

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 28985 of Alkaloids Corp

Looking for Drug Master Files (DMF) for 28985 of Alkaloids Corp 1

20

Alkaloids Corp, 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 HYOSCINE, with a corresponding US DMF Number 28985.

Remarkably, this DMF maintains an Active status since its submission on January 02, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 05, 2016, and payment made on March 25, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II