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List of Drug Master Files (DMF) for 30687 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 1Alchem International Private Ltd

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAlchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

GDUFA

DMF Review : Complete

Rev. Date : 2017-09-14

Pay. Date : 2017-06-02

DMF Number : 30687

Submission : 2016-07-06

Status : Active

Type : II

Alchem

Looking for Drug Master Files (DMF) for 30687 of Alchem International Private Ltd

Looking for Drug Master Files (DMF) for 30687 of Alchem International Private Ltd 1

20

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

They are recognized for Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

One of their notable products is HYOSCINE EP (SCOPOLAMINE), with a corresponding US DMF Number 30687.

Remarkably, this DMF maintains an Active status since its submission on July 06, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 14, 2017, and payment made on June 02, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II