About Us_ANBISON LAB

中

Contact number:

400 007 5658

Who Are We?
Anbison is a pharmaceutical company invested and operated by a number of pharmaceutical professionals at home and abroad; established in scientific development, manufacture and commercialization of pharmaceutical preparations. Anbison is dedicated to research, development (R&D) and production of high-end generic drugs which have its quality and efficacy in consistency with that of the original ones as well as improved new drug with clinical advantages; aimed at both domestic and oversea markets of pharmaceutical preparations; specialized in process scale up and manufacture of complex products; focused on quality assurance and production efficiency so as to provide patients with high-quality and affordable therapeutic drugs.

Who Are We?

Anbison is a pharmaceutical company invested and operated by a number of pharmaceutical professionals at home and abroad; established in scientific development, manufacture and commercialization of pharmaceutical preparations. Anbison is dedicated to research, development (R&D) and production of high-end generic drugs which have its quality and efficacy in consistency with that of the original ones as well as improved new drug with clinical advantages; aimed at both domestic and oversea markets of pharmaceutical preparations; specialized in process scale up and manufacture of complex products; focused on quality assurance and production efficiency so as to provide patients with high-quality and affordable therapeutic drugs.

15+ Year

Anbison has been working on drug preparation research and development for 14 years
50+ ANDA

50 plus products have been filed, 30 plus products have been approved
20000+ ㎡

Manufacture facilities for multi-dosage form, modified release and long-lasting injection production

Anbison was founded in 2007 and is registered in the Shanghai Caohejing Development Zone.From 2007 to 2015, Anbison was a CRO company engaged in drug research and development, providing R&D and registration service for domestic pharmaceutical companies in oversea markets such as the United State. In year of 2015,with the implementation of the new legislation on Market Authorization Holder (MAH) in China which is in line with international practice , Anbison became the first Chinese pharmaceutical R&D company who has no its own manufacture facility, but is qualified to file its own product in year of 2016 , and Anbison became the first Market Authorization Holder (MAH) of pharmaceutical products in year of 2018 as a R&D company in China. In the past decade, Anbison has successfully developed and filed more than 50 generics in the U.S and China market, more than 30 generics have been approved, of which 12 are owned by Anbison.

From year of 2018-2020, with the sales of Anbison products in China and US market，Anbison gained a massive growth. In year of 2020 We have built our own manufacture facility in Taizhou city, Jiangsu province and also expanded the R&D capability to complex generic such as liposome products.
With rich experience in scientific development, manufacture and commercialization of pharmaceutical preparations, Anbison is committed to providing Chinese and foreign patients with high-quality generics and modified new drugs that meet international quality standards, serving the Chinese, U.S. and European markets with the same production line and quality standards. In addition to having its own factory, Anbison has also built close cooperative relations with a number of leading domestic pharmaceutical companies, who are commissioned to manufacture for Anbison lab, in order to supply quality products for domestic and foreign patients.

Anbison R&D lab：Located at No. 18 Qujing Road, Xuhui District, Shanghai, China. With advanced lab size and pilot equipment and analysis laboratory.
Manufacture site：Located in Taizhou City, Jiangsu Province, with a construction area of more than 20,000 square meters, state of art facilities and equipment for manufacture of controlled release pellets, matrix & membrane controlled oral solid products and suppository products and a workshop specialized on liposome injection products
In addition to having its own factory, Anbison has also developed a number of qualified CMOs, which includes: Hangzhou Minsheng Pharmaceutical company, Shijiazhuang Pharmaceutical Company, Qingdao Bahale pharmaceutical company and Tesly Sant Pharmaceutical company, All of those CMO sites have received US FDA site inspection for many times and are actively supplying their products to US and EU markets.

Mission and Vision

Mission:

Development and Manufacture of high quality and affordable generic drugs and 505(b)2 products for both Chinese and foreign patients.

Vision：

To become one of China’s outstanding pharmaceutical companies, specialized on process innovation and scale up of manufacture .

Management Team

Advisory Board

Jifeng Lei

Founder, CEO

Master of Chemical Engineering, EMBA, visiting professor of International Pharmaceutical

Engineering Master (IPEM) program of Peking University, and Yeehong Business School of Shenyang Pharmaceutical University.

Chairman of ISPE China (2015-2016)

Over 20 years with Janssen, Sanofi and GSK as Operation Director and Plant General Manager. Founder and Owner of Anbison Lab. Co., Ltd. in 2007

With over 30 years’ experience in pharmaceutical industry, ever working pharmaceutical engineering, production, quality management, technical transfer, regulatory Affairs, plant management and pharmaceutical R&D.

Fujiang Zhu

Director
Renbao He

Director
Ronggen Jin

Formula Specialist, Director
Zhihang Lei

VP, Director
Sales & Marketing Director

Jianying Wang

International RA Specialist
Scientific Committee member
Dr. Anna Shen

Pharmaceutical Analysis Specialist
Scientific Committee member
Dr. GARTH BOEHM

Formula and RA Specialist
Scientific Committee member

The Course Of Development

- Anbison Lab was established in Shanghai in 2007.
- Our formulation laboratory was completed in 2008.
- We held the first international generic drugs forum in 2009.
- Participated in the revision of the 2010 edition of the Chinese Good Manufacture Practice (GMP) for medicines.
- Successful facilitation for the first client to receive U.S. FDA site inspection on cGMP.
- Anbison had its first client receiving product approved by US FDA for sale in the United States.
- Anbison received the special funds by Shanghai Science and Technology Innovation.
- First product of Anbison, Montelukast chewing tablets were approved for sale in the United States.
- Montelukast 10mg tablet was approved for sale in the United States.
- Anbison was recognized as a high-tech enterprise in Shanghai.
- Bupropion XL extended released tablets were approved for sale in the United States.
- Anbison received a 5-million-dollar investment from a listing company, Yongtai Technology (SZ:002326).
- Anbison is qualified to jointly undertake 3 new drug projects sponsored by National Science and Technology Committee in China.
- Anbison is qualified to independently undertake 2 new drugs projects sponsored by National Science and Technology Committee in China.
- Montelukast 4/5mg chewing tablets and 10mg tablets were approved for sale in China. and therefore Anbison became the first R&D company in China which is qualified as the Market Authorization Holder (MAH) of pharmaceutical product.
- Anbison’s Montelucast tablet won the bidding in the national campaign of volume based purchase for 4 major cities, Beijing/Shanghai/Tianjin/Chongqing and other 7 cities in China.
- Anbison invested ten million to a API company, Jiangbei Pharmaceuticals in Zhejiang province.
- Anbison’s Montelukast 10mg tablets won the bidding in the national campaign of volume base purchase for 13 provinces and accounts for the major market share in China.
- Anbison is qualified to independently undertake another 2 major national new drugs projects sponsored by National Science and Technology Committee in China.
- Tamsulosin Hydrochloric Sustained release Capsule of 0.4mg was approved for sale in the United States.
- Tamsulosin Hydrochloric Sustained-Release Capsule of 0.2mg was approved for sale in China.
- Tamsulosin Hydrochloride Sustained-Release Capsules and Montelukast Sodium Chewing Tablets won the bidding in the third batch of national campaign of volume base purchase.
- Anbison manufactuer facility was built up in China Medicine City (CMC) in Taizhou, Jiangsu Province.
- A subsidiary of Anbison was established in the UK in 2020.
- Anbison was named as one of “TOP TEN” high tech company in Shanghai ,China.
- Jiangsu Anbison obtained “Drug Manufacturing Lisence” issued by NMPA.
- Felodipine Sustained Release Tablet, the first drug passing Generic Consistency Evaluation, was approved for sale in China.
- Anbison ranked 6th in the Top 50 Growth of Chinese Pharmaceutical Industry in 2020.
- Carbamazepine Extended-Release Tablet was approved by FDA in United States.
- Anbison was awarded “Zhanjiang Star” enterprise title by Shanghai STVC Group.
- Jiangsu Anbison passed the on-site inspection of tablet GMP compliance.
- Anbison received “Xuhui District Quality award”.
- The aseptic preparation project of Taizhou Factory was completed.
- The Phase I project of Jiangsu Ambison started operation and sold, and the Phase II project was completed.
- Jiangsu Anbison passed cGMP on-site inspection of the US FDA.
- Shanghai Anbison R&D and office building was officially put into use.
- Anbison was awarded Xuhui District Technology Center for its R&D system.