JAPAN GMP ACCREDITATION, 2015

On 06 January 2015, STADA – VN J.V. Co., Ltd., Binh Duong Branch (the “STELLA” or “Factory II“), was appreciated by Ministry of Health, Labour and Welfare (the “MHLW”) issued the certificate of Japan GMP for the product of Soleton 80 with its composition and strength: Zaltoprofen 80 mg after conducting GMP inspection by the Department of Pharmaceutical and Medical Devices, Japan (“PMDA”) to qualify Stella’ facility from 07 October 2014 to 09 October 2014 and evaluate its entire production line for the mentioned product.

The Ministry of Health of Japan licensed activity in pharmaceutical sector to Stella on 26 February 2013 with accreditation certification no. AG11000004 for foreign pharmaceutical company that to export drugs to the Japanese market, after its review and evaluation of Stella’s facilities and equipment of the manufacturing plant via document inspection submitted to them on February 2012.

In fact, Japan is a member of PIC/S, the Pharmaceutical Inspection Co-operation Scheme, and is a country having strict and stringent quality management system  applying the cGMP standard such as EU-GMP, U.S. FDA, Japan GMP, etc. for medicines, medical equipment and equipment.

In Japan, the Basic Law was enacted in 2002 in which pharmaceutical items were constantly emended and developed (notably the 2005 Revision of Pharmaceutical Trade Act). The Japanese Agency is responsible for pharmaceutical management of the Ministry of Health, Labour and Welfare (“MHLW”)and the Pharmaceutical and Medical Devices Agency (“PMDA”), while the Ministry of Health, Labour and Welfare is the governing body responsible for controlling both pharmaceutical and medical devices  and the Pharmaceutical and Medical Devices Agency is the sole body conducting the appraisal and granting the Japan GMP Certificate for the registered drug.

The assessment process for recognition of Japan GMP standard consists of two phases:

1. licensing the Accreditation Certificate for pharmaceutical activity in Japan; and
2. inspecting and accrediting the Japan GMP for the registered drug.

Our manufacturing unit accredited with GMP certificates by the authorities such as EMA, WHO, PIC/S, PMDA, Taiwan FDA, etc. Stella One Team always keen to maintain cGMP standards for its production with the pioneer aiming to production and supplying generics drugs for the needs of our patients worldwide.

About STELLA

STELLAPHARM is one of leading generics pharmaceutical companies and strong producer of anti-viral drugs in Vietnam. The company established in Vietnam in 2000; and focuses on both prescription drugs and non-prescription especially in cardiovascular diseases, anti-viral drugs, anti-diabetics drugs, etc. and our products are now used by millions of patients in more than 50 countries worldwide.

The company is globally recognized for its quality through our facilities have been audited and approved by stringent authority like EMA, PMDA, Taiwan GMP, local WHO and others.

Additional information for this article: Stellapharm J.V. Co., Ltd. – Branch 1
A: 40 Tu Do Avenue, Vietnam – Singapore Industrial Park, An Phu Ward, Thuan An Town, Binh Duong Province, Vietnam
T: +84 274 376 7470 | F: +84 274 376 7469 | E: info@stellapharm.com | W: www.stellapharm.com