Changes in Chinese regulations now allow Wuxi Griffin as a foreign CMO to operate in China

Wuxi Griffin Pharmaceuticals Co. Ltd. takes advantage of the changes in Chinese policies allowing CMOs to operate in China. Wuxi Griffin is a new Swedish-Chinese partnership to serve as an international contract manufacturer of aseptic fill pharmaceuticals.

The filling facility is in Wuxi, China, with Western management. The aim is to fill complying to international GMP standard. Very few CMOs have been able to accomplish compliance to international standards, in the Chinese market. There is a gap between the Chinese manufacturers capabilities and the regulatory requirements from the West.

Because of the recent changes in Chinese legislation, a limited number of foreign CMOs have had the opportunity to establish their presence in China. This gives foreign CMOs like Wuxi Griffin, as an international supplier of aseptic fill pharmaceuticals, a great advantage.

“We meet the needs of our Chinese customers wanting western quality pharmaceuticals but also assist western pharmaceutical companies to a fast-track release of their products to the Chinese market”, says Torgny Lundgren, CEO of Wuxi Griffin.

As China has opened up the doors for CMOs, foreign companies are likely to take advantage of this opportunity as the Chinese pharmaceutical market is the fastest growing in the world.

“Wuxi Griffin is able to help companies wanting to expand internationally but choose or might not have the necessary capacity or competence to fill in-house. We have the necessary experience and know-how in aseptic filling of pharmaceuticals, especially regarding compliance to Western GMP”, highlights Torgny.

Company name: Wuxi Griffin Pharmaceuticals Co. Ltd.
Address: No. 4 Rongyang 1st Road, Xishan Economic Zone
Wuxi, Jiangsu Province, CHINA
214191

Contact
Diana Lam, Marketing Manager
diana@wuxigriffin.com
+46 (0)72 421 08 12
www.wuxigriffin.com

Wuxi Griffin serves as an international contract manufacturing organization specializing in aseptic fill and finish of injectable pharmaceuticals. We provide aseptic filling in ampoules and vials of flexible sizes and batches, for clinical trial as well as commercial production. In our state-of-the-art manufacturing plant in Wuxi, China, we offer Isolator and RABS based filling technology of aqueous solutions. All of our sterile fill and finish manufacturing comply to Western GMP quality standards and we are able to serve customers globally.

In our state-of-the-art 2550 sqm / 27450 sqft GMP compliant manufacturing facility located in Wuxi city in China we have an integrated manufacturing system in place. Our reliable manufacturing technology include:
- Isolator-based aseptic vial filling line for aqueous solution products
> Glass and polymeric vials (0.5ml – 30ml; 13mm and 20mm stoppers)
> 1200 – 1500 units per hour based on the smallest vial size of 2R
> 200 – 10000 units per batch in automated filling

- RABS-based ampoule filling line for aqueous solution products with terminal sterilization of filled products (superheated water autoclave)
> Glass ampoules (2ml – 20ml)
> Up to 18000 units per hour for the smallest ampoule size of 2ml

This release was published on openPR.