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Analysis: Chinese Pharmaceutical Enterprises Obtained EU GMP Certificates in the First Half of 2015

July 15, 2015 By zhulikou431

Though the “failure” of North China Xiantai Pharmaceutical Company in EU GMP inspection at the beginning of 2015 became a hot topic among pharmaceutical enterprises, the technical level and GMP management level of Chinese pharmaceutical enterprises have been continuously achieving innovation and breakthroughs, and many pharmaceutical enterprises have been closely watching the overseas market, making smooth progress in achieving EU GMP certifications.

I have sorted out the Chinese pharmaceutical enterprises (the attached table) having obtained EU GMP certificates in the first half of 2015 (subject to the issuing time) according to the data published in EU database.

We can see from the attached table that a total of 35 enterprises having obtained EU GMP certificates in the first half of 2015, of which many enterprises have obtained many EU GMP certificates or obtained an EU GMP certificate for many times, such as Elanco (Shanghai) Animal Health Co., Ltd., Shenzhen Haibin Pharmaceutical Co., Ltd., Qilu Antibiotics Pharmaceutical Company Limited, Zhuhai United Laboratories Co., Ltd., Zhejiang Huahai Pharmaceutical Co., Ltd., Qilu Tianhe Pharmaceutical Company Limited, Beijing Novartis Pharma Co., Ltd., Hebei Huarong Pharmaceutical Co., Ltd., and Zhejiang Jiuzhou Pharmaceutical Co., Ltd. Analyzed from the certification types,  a total of 9 enterprises purely achieving API certifications; the number of preparation enterprises for EU certification has been obviously increased, especially including many sterile preparation enterprises, manifesting that the international certification level of China is constantly improving and thus reversing the awkward situation where the export of Chinese pharmaceutical products rely on APIs.

English name

Certification type

Issuing date

Zhejiang Zhenyuan Pharmaceutical Co., Ltd

Preparation

2015-01-09

Ningbo Renjian Pharmaceutical Group Co., Ltd.

Preparation for veterinary use

2015-01-12

ELANCO (SHANGHAI) ANIMAL HEALTH CO., LTD

Preparation for veterinary use (non-sterile)

2015-01-28

Shenzhen Hepalink Pharmaceutical Co, Ltd.

Preparation

2015-02-02

QILU TIANHE PHARMACEUTICAL COMPANY LIMITED

Preparation (sterile)

 

2015-02-04

QILU PHARMACEUTICAL (HAINAN) CO.LTD

Preparation (sterile)

 

2015-02-05

Shenzhen Zhijun Pharmaceutical Co. Ltd

Preparation (sterile)

 

2015-02-12

Beijing Novartis Pharma Co., Ltd.

Preparation (non-sterile)

2015-02-13

Shenzhen Haibin Pharmaceutical Co. Ltd.

Preparation (sterile)

2015-02-24

SHIJIAZHUANG YILINGPHARMACEUTICAL COMPANY LIMITED

Preparation (non-sterile)

2015-02-25

ZHEJIANG LANGHUA PHARMACEUTICAL CO., LTD – LINHAI

Preparation and API

2015-02-25

QILU ANTIBIOTICS PHARMACEUTICAL COMPANY LIMITED

Preparation and API

2015-02-27

Zhejiang Hisun Pharmaceutical Co., Ltd.

Preparation for veterinary use

2015-03-02

Hunan Yuantong Pharmaceutical Co Ltd

API

2015-03-03

HEBEI HUARONG Pharmaceutical

Preparation and API

2015-03-04

Yangtze River Pharmaceutical Group Co. Ltd.

Preparation (non-sterile)

2015-03-12

Yangtze River Pharmaceutical Group Jiangsu Pharm. Co. Ltd.

Preparation

2015-03-12

Zhejiang Huahai Pharmaceutical Co. Ltd.

Preparation (non-sterile)

2015-03-17

ZHEJIANG JIUZHOU PHARMACEUTICAL CO. LTD

API

2015-03-24

Nantong Chanyoo Pharmatech Co.,Ltd

API

2015-04-01

Qilu Tianhe Pharmaceutical Co. Ltd.

Preparation (sterile)

2015-04-10

North China Pharmaceutical Huasheng

Preparation and API

2015-04-10

Wuhan Grand Hoyo Co., Ltd.

Preparation

2015-04-13

Salubris Pharmaceuticals Co., Ltd.

Preparation (non-sterile)

2015-04-23

Hisun Pharmaceutical (Hangzhou) Co., Ltd.

Preparation for veterinary use

2015-04-23

Changzhou Qianhong Bio-Pharm. Co., Ltd.

Preparation

2015-04-27

Zhejiang Apeloa Kangyu Bio-Pharmaceutical Co. Ltd.

Preparation for veterinary use

2015-05-12

Wellpharm Pharmaceutical Co. Ltd.

API

2015-05-19

Shandong Lukang Shelile Pharmaceutical Co., Ltd

Preparation for veterinary use (non-sterile)

2015-05-19

BEIJING NOVARTIS PHARMA LIMITED

Preparation (non-sterile)

2015-05-20

Sino-Swed Pharmaceutical Corp. Ltd.

Preparation (sterile)

2015-05-20

Qilu Tianhe Pharmaceutical Co., Ltd.

Preparation

2015-05-21

Fujian Green Pine Co., Ltd

Preparation

2015-05-27

BrightGene Fine Chemical Co., Ltd.(subsidiary of BrightGene Bio-Medical Technology Co., Ltd.)

API

2015-06-05

BrightGene Pharmaceutical Co., Ltd. (subsidiary of BrightGene Bio-Medical Technology Co., Ltd.)

API

2015-06-05

Ningbo Smart Pharmaceutical Co. Ltd.

API

2015-06-12

Hebei Huarong Pharmaceutical Co Ltd - HEBEI PROVENCE

Preparation and API

2015-06-12

ZHUHAI UNITED LABORATORIES CO., LTD

API

2015-06-15

Novo Nordisk Tianjin

Preparation (sterile)

2015-06-17

ZHEJIANG HUAHAI PHARMACEUTICAL CO. LTD

API

2015-06-19

Zhejiang Jiuzhou Pharmaceutical Co. Ltd.

API

2015-06-26

However, there were enterprises in the above whose GMP certificates were revoked due to deficiencies found during the inspection by foreign institutions in the first half of 2015, for example, the EU GMP certificate of Zhuhai United Laboratories was cancelled due to its sterile processing deficiency.

In the distribution of the above certificates, there are 31 preparation GMP certificates in total, accounting for 70% of the total of 44 certificates, showing that the transition of Chinese pharmaceutical enterprises from APIs to preparations is fast.

There are 6 veterinary drug GMP certificates in total, accounting for 13.6% of the total of 44 certificates, showing that the internationalization trend of veterinary drug manufacturing enterprises is not obvious, still having a long way to go.

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