Chemwerth Shanghai Laboratory
is State of the Art Equipped

cGMP Compliance established in 1999 and FDA cGMP/GLP Inspected
and Approved in 2003 and 2005

Using modern equipment and the latest software, the Shanghai Laboratory is an important factor for choosing chemwerth.

Fully Independent and Funded by Chemwerth Inc.

Allowing us unlimited resources in method development and analysis.

Clean room validation

Latest airborne particle counters and microbial counting equipment used in clean room classification and validation.

Capabilities

HPLC analysis, GC/Headspace analysis, Laser and Air Jet Particle Size analysis, pH and KF determination, Stability studies accelerated and ambient, and Degradation studies.

We have strengthened our laboratory by the addition of another HPLC-DAD and IC-PAD which will enhance our ability to develop and analyze a variety of compounds.

Chemwerth Forms New Joint-Venture

chemwerth, Inc. of Woodbridge, CT. and Tianjin Weijie Technology Co., Ltd of Tianjin, China recently established a joint venture to develop and scale-up lab processes for eventual API contract manufacturing.

Under the leadership of Peter Werth, chemwerth's experience in developing new API products coupled with our strong regulatory, analytical and technical support in the cGMP manufacturing of generic API’s, has generated a proven track record of success in supplying high quality API to Finished Dosage manufacturers for over twenty years.

WeiJie, under the experienced and successful leadership of Dr. Song Honghai, has demonstrated speedy turn around times in developing high quality, economically viable chemical manufacturing processes.

Our combined expertise, plus chemwerth's existing presence in China created a perfect fit and augments our core competency as a drug development company. The joint venture, Tianjin Weijie – Chemwerth Science & Technology Co., Ltd. has created three research groups with two organic chemists per group. Senior scientists lead each group and work on a minimum of four projects per year. This will result in 12 API process developments per year (6 lab scale processes and 6 commercial scale processes).

This significant partnership positions chemwerth to select and manage custom projects creating a distinct advantage over the competition. For companies using API for generic drug launch and alternate source work, new drug compound development, key intermediate sourcing and contract finished dosage forms; this JV Company will enable unprecedented speed to market. For API and Finished Dosage manufacturers alike, that means more first approvals – providing one more reason to choose chemwerth, Your Guide to Pharmaceutical Success.

For details on our Manufacturing capabilities, please visit our Partners in Excellence page.