Navigation Links
Asymchem Announces sFDA Certification for Drug Product Manufacturing
Date:6/4/2009

TEDA TIANJIN, China, June 4 /PRNewswire/ -- Asymchem Laboratories, Inc., a leading research-based contract manufacturer of intermediates, API's and drug products to the pharmaceutical industry, is pleased to announce the issuance by the Tianjin branch of the Chinese State Food and Drug Administration (sFDA), a manufacturing certificate for drug products to our Tianjin 2 site. This qualifies Asymchem to manufacture oral solid dosage forms including tablets, capsules, and pellets.

Asymchem offers preclinical and drug product programs that include preformulation and formulation development, and clinical supply manufacturing of oral dosage forms. Housed in a 250 m2 state-of-the-art facility in Asymchem's Tianjin 2 site, Asymchem's drug product manufacturing facility is capable of producing up to kilogram scale of tablets or capsules per batch to support phase 1 and phase 2 clinical studies. Separate facility of similar scale exists for manufacture of dosage forms containing highly potent or cytotoxic compounds. Meanwhile, a much larger drug product facility for commercial manufacturing is being built and expected to be operational by 2Q 2010.

"We feel drug product capabilities to support all phases of our collaborator's research, development, and manufacturing are a logical extension of our long-standing capabilities in API development and manufacturing," states Dr. Hao Hong, CEO of Asymchem. "Our recent successful sFDA audit demonstrates that we bring the same focus on quality and regulatory compliance to our drug product programs that we have always brought to our API programs."

Dr. Xiaorong He, director of Formulation Development for Asymchem adds: "Operating to the highest technical and regulatory standards is part of the Asymchem culture, and our recent certification demonstrates our commitment to these ideals."

Asymchem Laboratories is a leading research-based contract manufacturer specialized in the development and compliant manufacturing (Contract Research and Manufacturing Services) of API's and Drug Products serving the pharmaceutical industry. With a 14 year track record, Asymchem is committed to the highest level of quality and excellence in the integrated CMC services arena. For further information, please visit the Asymchem website at www.asymchem.com.


'/>"/>
SOURCE Asymchem Laboratories, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Asymchem Continues to Maintain a Good Running Posture, Despite Economic Crisis
2. Asymchem Announces Opening of High Potency API and Drug Product Facility
3. LOHAS Announces Final Program Line-up Including Speakers from Wal-Mart, Coca Cola, MINI, Facebook Causes, Saatchi & SaatchiS, Gaiam and eBay
4. Healthcare Data Services (HDS) Announces HDS Expert(SM)
5. Aesthera Announces Installation of 1000th Photopneumatic System in US
6. Anadys Pharmaceuticals, Inc. Announces Pricing of Common Stock and Warrant Offering
7. Cepheid Announces Symposium Program for 2009 Association for Professionals in Infection Control (APIC) Annual Conference
8. Anpath Group, Inc. Announces Selection of its Cleaner by the Toronto Transit System
9. Xanodyne Announces New President/CEO and Completes $38 Million Equity Financing
10. US Oncology, Inc. Announces $465 Million Senior Secured Notes Offering
11. DATATRAK Announces Receipt of NASDAQ Panel Decision to Delist Common Shares
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2016)... Durham, NC (PRWEB) , ... May 04, 2016 ... ... healthcare professionals in medical coding, billing and compliance. In upcoming months, AudioEducator has ... on various specialties. Every conference is designed to give complete compliance know-how and ...
(Date:5/4/2016)... (PRWEB) , ... May 04, 2016 , ... ... Patient 2016, a powerful cellular therapy software application that helps blood and ... to patients. , Since Transtem’s initial launch, Mediware has continued to enhance core ...
(Date:5/4/2016)... ... ... Fertility Centers of New England announced today the opening of their newest location ... access to care for patients seeking fertility treatment in Maine. “We are delighted to ... Portland,” said Fertility Centers of New England President and CEO, Joseph A. Hill, M.D. ...
(Date:5/3/2016)... , ... May 04, 2016 , ... ... 40 national and global construction firms representing the Construction Industry Safety Initiative (CISI) ... forces with one purpose: to inspire everyone in the industry to be leaders ...
(Date:5/3/2016)... , ... May 03, 2016 , ... ... Business Journal, patients report dissatisfaction with numerous issues related to medical care in ... with billing, and poor bedside manner from hospital staff. Commenting on this article, ...
Breaking Medicine News(10 mins):
(Date:5/3/2016)... 3, 2016 Norgine ... sie einen entscheidenden Meilenstein durch diese Veröffentlichung ... zum Handeln, um Patientenresultate  bei Verdauungs- und ... Fortschritten im Verständnis der Hepatischen Enzephalopathie bei ... für Hepatische Enzephalopathie in der Öffentlichkeit zu ...
(Date:5/2/2016)... -- While nearly three-quarters of Americans (71%) are aware of ... only about half report taking any steps to prevent ... new survey announced today by Hologic (Nasdaq: ... Month, Hologic is raising awareness of this major threat ... Osteoporosis is a disease that causes low ...
(Date:4/29/2016)... , April 29, 2016 ... H1 2016" market research report that provides an ... comparative analysis at various stages, therapeutics assessment by ... administration (RoA) and molecule type, along with latest ... also reviews key players involved in the therapeutic ...
Breaking Medicine Technology: