KEY PRODUCTS
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 1Chunghwa Chemical Synthesis & Biotech
01 1MYCOPHENOLATE MOFETIL USP
01 1Taiwan
01 1Active
01 1Complete
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-01
Pay. Date : 2016-11-22
DMF Number : 18494
Submission : 2005-07-11
Status : Active
Type : II
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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 MYCOPHENOLATE MOFETIL USP, with a corresponding US DMF Number 18494.
Remarkably, this DMF maintains an Active status since its submission on July 11, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 01, 2017, and payment made on November 22, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
