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State Food and Drug Administration (China)

American Oriental Bioengineering Undergoing SFDA Directed Inspection of Capsules

Apr 20 | News

American Oriental Bioengineering, Inc., today announced that four out of its five manufacturing subsidiaries are undergoing onsite short notice inspections directed by China State Food and Drug Administration ("SFDA").  

China Suspends Sale of Drugs in Unsafe Capsules

Apr 16 | News

BEIJING (AP) — China's State Food and Drug Administration has suspended the sale of 13 drugs that it says are believed to have been made with capsules that contain excessive chromium.  

Novartis Receives Chinese OK for Eye Drug Lucentis

Jan 18 | News

Novartis said today that it received Chinese regulatory approval for its eye drug Lucentis, and it is launching the diabetes treatment Galvus in China.  

WuXi PharmaTech Awarded GLP Certificate from SFDA for Suzhou Toxicology Facility

Nov 8 2010 | News

WuXi PharmaTech, a pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, today announced that it had been awarded a Certificate of Good Laboratory Practice (GLP) compliance from the State Food and Drug Administration (SFDA), China's regulatory authority for pharmaceuticals, for its toxicology facility in Suzhou.

Simcere Pharmaceutical Group Receives SFDA Approval to Manufacture and Market Palonosetron in China

Aug 12 2010 | News

Simcere Dongyuan Pharmaceutical Co., Ltd. has recently received SFDA new drug certification and registration approval to manufacture and market Palonosetron material and injections in China.

NeoStem's Suzhou Erye Pharmaceutical Subsidiary Passes Government Inspection for Two Manufacturing Lines at its New Facility

Jun 15 2010 | News

NeoStem, Inc., an international biopharmaceutical company with operations in the U.S. and China, announced that its Suzhou Erye pharmaceutical subsidiary ("Erye") passed the government inspection by the State Food and Drug Administration ("SFDA") in China to manufacture penicillin powder for injection and cephalosporin powder for injection at its new manufacturing facility which provides 50% greater manufacturing capacity than its existing plant.

Chinese Drug Regulation Official Fired Amid Probe

Jun 14 2010 | News

BEIJING (AP) — The deputy head of China's food and drug regulator is being investigated and has been dismissed from his post, a state news agency said Sunday, citing an anti-corruption agency.

Sinovac Selected by Beijing CDC to Supply Hepatitis A Vaccine Healive(R)

Jun 1 2010 | News

Sinovac Biotech Ltd., a China-based vaccine manufacturer, announced today that it has received the confirmation from the China International Tendering Company that Sinovac was selected by the Beijing Centers for Diseases Control and Prevention (Beijing CDC) to supply the Company's hepatitis A vaccine, Healive, to the Beijing Expanded Program of Immunization (EPI).  

Sinovac Submits Clinical Trial Application for Mumps Vaccine to SFDA

May 5 2010 | News

Sinovac Biotech Ltd., a China-based vaccine manufacturer, announced today that its 30%-owned joint venture, Sinovac Dalian, has submitted an application to China's State Food and Drug Administration (SFDA) to commence human clinical trials for its mumps vaccine.

Blogs

The Tale of Two Deviations

The Tale of Two Deviations

Apr 23 | The QA Pharm

It stands to reason that pharmaceutical companies in compliance trouble also have problems with their Deviation Management and Corrective and Preventive Action (CAPA) System(s).

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Apr 16 | Girish Malhotra, PE, President, EPCOT International

The answer is an unequivocal yes but we need some outsiders who can conspire with the insiders who will be the flag bearers within the companies. Outsiders can be the counsels/co-conspirators to the insiders for the coup d'etat.

Multimedia

Lung Cancer Drug Treats Rare Lymphoma Tumors

Lung Cancer Drug Treats Rare Lymphoma Tumors

May 17 | Video

A new study found Xalkori effective in treating anaplastic lymphoma among children, an encouraging development for gene-targeted therapy.

Merck - 2012 Facility of the Year Award - Facility Integration

Merck - 2012 Facility of the Year Award - Facility Integration

May 14 | Video

Brian Morrissey, Senior Project Engineer, Merck Manufacturing Division, talks to Pharmaceutical Processing's Editor In Chief Mike Auerbach during INTERPHEX 2012 about the company's Vaccine Bulk Manufacturing Facility Program of Projects. The facility has won the Facility Integration award in the 2012 Facility of the Year Award competition sponsored by ISPE, INTERPHEX and Pharmaceutical Processing magazine.

Medicine from a Vending Machine?

Medicine from a Vending Machine?

May 3 | Video

A Chinese company is pushing for acceptance of traditional Chinese medicine with a machine that can dispense herbs.

Taking Precautions to Prevent Contagion

Taking Precautions to Prevent Contagion

Apr 29 | Video

With the recent outbreak of viruses such as SARS, bird flu and swine flu, officials and travelers are being extra careful about preventing the illnesses from being transmitted.

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