Quality Certification

Yung Zip Chemical's products are registered with DMFs in Taiwan, the United States, Canada, Japan and the European Union. We market to Europe, the United States, Canada, Japan, Australia and other parts of the world and have long-standing collaboration with other reputed pharmaceutical companies.

With an eye to market competitiveness, Yung Zip Chemical has taken the initiative to meet FDA's GMP standards for active pharmaceutical ingredients since 1990. Over the years, many products have passed FDA inspection and have been marketed in the US. Yung Zip Chemical has thus accumulated years of valuable cGMP experience over the course of many US FDA inspections and regulatory submissions. In addition, we continuously strive to meet international standards, having passed the PIC/S GMP inspection of the PMFA of Japan and PIC/S GMP, PIC/S GDP inspection of the Food and Drug administration of Taiwan.


Yung Zip Chemical has a well-equipped quality control laboratory, including GC, HS-GC, HPLC, IR, UV, ICP-OES, Laser Particle size analyzer, etc., compliant with modern international regulatory and quality standards (including data integrity).

Yung Zip Chemical has successively introduced products meeting this high-level manufacturing standard to ensure the their excellence and stability. Yung Zip Chemical has a history of leading the industry, being the first company to obtain GMP certification of the Taiwan Department of Health in 1993. The quality of the products conforms to domestic and international standards, as indicated by our regulatory inspection and certification history (see following table)

US FDA Inspection

Year

Product

FDA Classified as

2023/07

General cGMP Inspection

VAI

2018

General cGMP Inspection

VAI

2015

General cGMP Inspection

Closed

2012

General cGMP Inspection

Acceptable

2007

Diclofenac Sodium

Acceptable

2001

Diclofenac Sodium

Acceptable

1997

Diclofenac Sodium, Acyclovir &
Miconazole Nitrate

Acceptable

1995

Diclofenac Sodium

Acceptable

1992

Diclofenac Sodium &
Miconazole Nitrate

Acceptable

1990

First Inspection

Acceptable


Taiwan FDA Inspection

Year

Product

Classified as

2022/09

Facility general inspection

GMP Certificate

2021

Ferric oxyhydroxide Gum Arabic complex (VS-505) (VY01)

GMP Certificate

2019

Facility general inspection

GMP Certificate

2018

Diclofenac Sodium (Process II), Miconazole Base

GMP Certificate

2018

Deferasirox, Zolpidem Tartrate

GMP Certificate

2016

Valacyclovir HCl

GMP Certificate

2015

Diclofenac Acid, Modafinil

GMP Certificate

2015

Facility general inspection

GMP Certificate

2015

Clonidine HCl, Diclofenac Potassium, Econazole Nitrate

GMP Certificate

2013

Facility general inspection, Metoprolol Succinate

GMP Certificate

2010

Facility general inspection

GMP Certificate

2008

Mefenamic acid, Sodium Starch Glycolate

GMP Certificate

2006

Acyclovir, Miconazole Nitrate

GMP Certificate

2003

First Inspection, Diclofenac Sodium

GMP Certificate


Japan PMDA Inspection

Year

Product

Classified as

2017

Acyclovir

GMP Certificate

2013

Diclofenac sodium, Miconazole nitrate, Valacyclovir HCl

GMP Certificate

2009

Diclofenac sodium, Miconazole nitrate

GMP Certificate