Zhejiang Chiral Medicine Chemicals Co.,Ltd.
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API Introduction

 

Founded in 1998, Zhejiang Chiral Medicine Chemicals Co., Ltd (CMC) is located at Zhejiang Nanyang Economic Development Zone and occupies an area of 15,000m2.The company, specializing in generic APIs and pharmaceutical intermediates, has been accredited as a high-tech enterprise by Zhejiang Province.

QA, QC and R&D departments were set up along with the company in 1999, and are staffed with highly trained professionals, including some M.S and Ph.D. scientists. With powerful developing and manufacturing capabilities,CMC strives to meet the requirements of our customers with the highest quality products with innovative technologies. We are particularly specialized in synthesizing chiral pharmaceutical products, which is also the main direction of the company. During the past few years recent years, CMC developed a series of products and manufactured them following the GMP procedure, including Methyldopa , Gabapentin , Etodolac .

At present, there are about 200 employees in the company, with 20% of them being R&D staff. The company has achieved excellence in analysis, research and development. It is our aim to expand our product lines with the highest quality to customers around the globe.

In 2008, CMC have registered successfully in Canada for Gabapentin and Etodolac. In 2009, CMC obtained Gabapentin GMP certificate from SFDA and TGA certificate from Australia government. In 2010, CMC got new CEP certificate for Carbidopa from EDQM and approved by EDQM inspection. In January 2011, CMC got new CEP certificate for methyldopa and Etodolac from EDQM. In August of 2011, US FDA inspected us for Gabapentin and approved us,CMC received the acceptance letter and EIR report. In July of 2012, Germany Hamburg Authority inspected us and approved us, we got Gabapentin Germany EU GMP. During Jan.25-29th,2013, US FDA inspected our site, we got FDA approval for all the products (Gabapentin, Carbidopa, Etodolac, Methyldopa). In 2013, We got Etodolac GMP certificate from SFDA. In 2016, we got Carbidopa GMP certificate from SFDA. US FDA inspected our site again on Aug.9-11 2016, and we got FDA approval for all the products (Gabapentin, Carbidopa, Etodolac, Methyldopa). On Mar.28,2017, we received FDA close letter.

 

 

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