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Theqmnweeklybulletin

Jan. 25, 2008

Vol. 2 No. 4

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U.S. Gets Access to Chinese SFDA Inspection Information

China’s State Food and Drug Administration (SFDA) will provide the FDA with access to records from inspections and a list of manufacturers who do not meet Chinese standards. Read More

Merck's Varicella Production Issues Remain, Validation Expected Soon

Merck expects to complete validation of bulk varicella production in the coming months as it continues to correct manufacturing issues that have created supply disruptions for its varicella-containing vaccines ProQuad and Zostavax. Read More

FDA Not Focusing Inspection Resources Appropriately

The FDA is wasting its time conducting multiple GMP inspections of domestic manufacturers while not applying the same surveillance standards to production facilities overseas, a recent citizen petition says. Read More

Stryker Recalling Some Orthopedic Products

Stryker Corp. said it was voluntarily recalling two hip-implant components that it makes in Ireland. Read More

Nicholas Piramal Buys Healthline's Pharma Biz

Nicholas Piramal India Limited and Healthline Private Limited (HLPL) have signed a definitive agreement for purchase of HLPL’s Pharmaceuticals business by NPIL for a consideration of [$3.79 million]. HLPL has a modern injectables manufacturing unit at Bangalore for small and large volume injectable products. Read More

New HPAPI Plant for Novasep

French firm Novasep has significantly upped its capacity with a new high potency active pharmaceutical ingredient (HPAPI) plant at its facility in Le Mans, France. Read More

Julphar Invests in Yemeni Pharmaceutical Industry

The UAE-based Gulf Pharmaceutical Industries (Julphar) plans to spend about $406 million for expansion projects in seven countries, including Yemen, over the next three years. Read More

Benda's Jiangling Plant Receives Production Approval

Benda Pharmaceutical, Inc., a China-based pharmaceutical company producing both Gendicine, [a] gene therapy medicine for the treatment of cancer and traditional Chinese and conventional medicines, announced that its Jiangling plant has received approval from the State Food and Drug Administration (“SFDA”) to reinitiate production of its primary product line. Read More

Bio-Succinic Acid to Go Commercial

With the price of crude oil going up almost every day it is no surprise that this has a knock-on effect to the price of raw materials for the pharmaceutical and chemical industries. Read More