Henan Dongtai Pharm Co., Ltd. (HDP) with occupied area of 142200m2 and 336 employees is located at East Changhong Road, Tangyin, Henan Province of China.
Since founded, HDP has been dedicated in the developing, manufacturing and trading of bulk API and its intermediates, such as NSAIDs (Diclofenac series), steroids, antitumor drugs(CPT series),and antiviral drugs (Adamantane series),etc. Especially, HDP now has developed into the biggest manufacturer of diclofenac series in the world with an annual production size of 2000 tons.
By strictly following ICH guidelines, GMP regulations and its operation philosophy of “Health is critical, quality is primary” in both manufacturing and management area, HDP maintains a leading advantage and a reputation for high quality bulk API products in the world market.
Till now, HDP has been granted Chinese GMP Certificate, ISO9001-2000 certificate, European CEP Certificate. In addition, our DMF of Diclofenac Sodium has been registered in Russia Federal, Japan, Taiwan, Korea and etc.
Through its endless effort to benefit mankind, HDP is seeking for playing a role of responsible supplier for drugs with more safety and efficacy worldwide.
Henan Dongtai Pharmaceutical Co., Ltd. was founded in 2002. It is a comprehensive and modern GMP pharmaceutical enterprise integrating scientific research, production and sales. Since its establishment, it has taken the responsibility of revitalizing China pharmaceutical industry and striving to become an excellent pharmaceutical enterprise. After nearly 20 years of continuous innovation and development, it has gradually grown into a leader in the R & D, production and sales of APIs and pharmaceutical intermediates Enterprise.
The company has been recognized as a national high-tech enterprise, one of the top 100 enterprises in Henan Province, chiral drug Engineering Technology Center, export base for foreign exchange, postdoctoral research and development base, fifty top enterprises and excellent private enterprises in Anyang City, ten trustworthy enterprises and ten top enterprises in Tangyin county, The new technology application project of diclofenac sodium won the second prize of national science and Technology Progress Award and the honorary title of “China Quality and integrity enterprise” of China entry exit inspection and Quarantine Association for three consecutive years.
The company has a number of independent intellectual property core technologies, equipped with advanced analysis, detection, small-scale test and pilot test equipment, which are used in the research and development, production of anti-inflammatory, analgesic, anti-virus and other drugs harmful to human health. The annual comprehensive production capacity of diclofenac sodium, diclofenac potassium, rimantadine, acemetacin, aceclofenac, phenol and refined indolones is more than 3000 tons. The company adheres to the concept of “producing good medicine, benefiting the society”, strictly follows the guidelines of ichq7 and GMP in China, and passed the on-site certification and inspection of EDQM in May 2015; passed the on-site certification and inspection of FDA in September; passed the official PMDA certification of Japan in November; passed the re certification of EDQM and the certification of Yuanyuan logo in 2017, passed the on-site certification of FDA in 2018, ISO9000 on-site inspection, and quality assurance The quantity management system has been gradually improved. Among them, diclofenac series products have five system certification certificates in the world (European CEP certificate, Japanese GMP certificate, American FDA inspection certificate, ISO certification certificate, Korean GMP certificate) and domestic GMP certificate, and have become an important research and development, production, export base of diclofenac products in the world. More than 70% of the products are exported to Europe, North America, South America, Southeast Asia, Japan, South Korea and other countries Home and region, in the international market enjoys a good reputation.
In 2017, in response to the government instructions to leave the city and enter the park, the company invested 200 million yuan in the new plant area of Tangyin county industrial cluster area to upgrade the product process of diclofenac series product production line and multi-functional comprehensive workshop production line. The plant area covers 130 mu, with more than 300 employees, and the annual revenue will exceed 500 million yuan.
The company always adheres to the market demand as the core, product innovation as the guide, and the combination of production, learning and research. With its outstanding innovation ability, the company strives to achieve human health and social progress, and to build a global pharmaceutical brand enterprise!
Major events and development history
In 2002, Henan Dongtai Pharmaceutical Co., Ltd. was established.
In 2002, it acquired Guangzhou Baiyunshan Pharmaceutical Co., Ltd. Yuyue Pharmaceutical Factory, and established Baiyunshan Tangyin Dongtai Pharmaceutical Co., Ltd.
In 2007, the diclofenac sodium raw material drug production technology research and application scientific research project won the second prize of the annual national scientific and technological progress award.
In October 2008, Henan Dongtai Pharmaceutical Co., Ltd. Diclofenac Sodium API passed the European Union (COS) certification.
In March 2011, “the fully synthetic camptothecin series of anticancer drugs – irinotecan hydrochloride (topotecan hydrochloride) was recognized as a provincial scientific and technological achievement in Henan.
In 2012, Henan Dongtai Pharmaceutical Co., Ltd. Diclofenac Sodium API was registered with the US DMF.
In 2014, Henan Dongtai Pharmaceutical Co., Ltd. obtained the official certification of Mexico
In May 2015, Henan Dongtai Pharmaceutical Co., Ltd. obtained European COS certification
In July 2015, Henan Dongtai Pharmaceutical Co., Ltd. obtained the domestic ISO9000 certification
In September 2015, Henan Dongtai Pharmaceutical Co., Ltd. obtained the US FDA certification
Passed the Japanese official PMDA certification in November 2015
In 2017, passed the EDQM re-certification and the Fangyuan logo ISO2015 version certification
In 2018, passed the US FDA on-site certification and ISO9000 on-site inspection