Navigation Links
Asymchem Announces sFDA Certification for Drug Product Manufacturing

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

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:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... DevOps and Agile Software Development, has been awarded a contract by the Center ... Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in ...
(Date:10/13/2017)... ... ... On The Brink”: the Christian history of the United States and the loss of ... William Nowers. Captain Nowers and his wife, Millie, have six children, ten grandchildren, ... Navy. Following his career as a naval aviator and carrier pilot, he spent ...
(Date:10/12/2017)... Francisco, CA (PRWEB) , ... October 12, 2017 ... ... Dr. Cheng, are now treating sleep apnea using cutting-edge Oventus O2Vent ... apnea, a serious sleep disorder characterized by frequent cessation in breathing. Oral appliances ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... to meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s ... experts and tested to meet the highest standard. , These products are ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... The American ... Excellence to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium ... 8. , In honor of Morris F. Collen, a pioneer in the field of ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... 2017 The Rebound mobile app is poised to ... the tide of prescription drug addiction. The app empowers users ... and stepping down their dosage in a safe, controlled manner ... 2017; the first 100,000 people to sign up will enjoy ... ...
(Date:9/25/2017)... 2017   Montrium , an industry leader ... the IQPC Trial Master Files & Inspection Readiness ... EastHORN Clinical Services has selected eTMF Connect ... management. EastHORN, a leading European contract research organization ... transparency to enable greater collaboration with sponsors, improve ...
(Date:9/19/2017)... Inc., a venture-backed medical device company developing a non-invasive, robotically assisted, platform therapy that uses ... today:   ... Jim ... Tom Tefft ... Veteran medical device executive Josh Stopek , PhD, who has led R&D and business ...
Breaking Medicine Technology: