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01 1Chunghwa Chemical Synthesis & Biotech

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-01

Pay. Date : 2012-11-20

DMF Number : 26271

Submission : 2012-08-01

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 26271 of Chunghwa Chemical Synthesis And Biotech Co Ltd

Looking for Drug Master Files (DMF) for 26271 of Chunghwa Chemical Synthesis And Biotech Co Ltd 1

20

Chunghwa Chemical Synthesis And Biotech Co Ltd, based in Taiwan, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

One of their notable products is ETHYL ICOSAPENTATE, with a corresponding US DMF Number 26271.

Remarkably, this DMF maintains an Active status since its submission on August 01, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 01, 2013, and payment made on November 20, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II