KEY PRODUCTS
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
01 1Chunghwa Chemical Synthesis & Biotech
01 1RAPAMYCIN (SIROLIMUS)
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 : 2017-03-03
Pay. Date : 2017-01-04
DMF Number : 31189
Submission : 2016-12-30
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 RAPAMYCIN (SIROLIMUS), with a corresponding US DMF Number 31189.
Remarkably, this DMF maintains an Active status since its submission on December 30, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 03, 2017, and payment made on January 04, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
