Baxter and Apotex are not on this FDA list, so they must be subcontracting manufacturing to another company.
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE; INJECTION Prescription No AP 065329 ACS DOBFAR
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE; INJECTION Prescription No AP 065231 ORCHID HLTHCARE
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE; INJECTION Prescription No AP 065204 SANDOZ
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE; INJECTION Prescription No AP 065180 WOCKHARDT
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE; INJECTION Prescription Yes AP 050796 B BRAUN
ROCEPHIN CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE; INJECTION Prescription Yes AP 063239 HLR - This is the brand name
Posted by nannie (Member # 5250) on :
CD 57: if this link to Baxter is valid, they may have changed their subcontractor sometime after 2005
At the bottom of the package insert, it says that ceftriaxone is manufactured for Baxter by Lupin, Mumbai India, and then gives a package insert date revision of 2005
Posted by nannie (Member # 5250) on :
Weston, FL (August 2, 2005) -- Apotex Corp. today announced that Orchid Chemicals & Pharmaceuticals Ltd. based in India has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for ceftriaxone for injection, 250mg, 500mg, 1gm and 2gm vials; 1gm and 2gm piggyback vials and 10gm pharmacy bulk pack.
Apotex in the U.S. will exclusively market Orchid's ceftriaxone as part of an agreement between the two companies, in which Apotex will exclusively distribute several cephalosporin injectables developed by Orchid. Shipments of the drug are expected to commence immediately. Ceftriaxone for injection is AP-rated to Roche's Rocephin�, an injectable third generation cephalosporin antibiotic. U.S. annual sales of ceftriaxone are approximately $700 million.
Orchid, established in 1992, is a global pharmaceutical company headquartered in Chennai, India, and is among the top ten pharmaceutical companies in India based on sales. Orchid generated sales in fiscal 2004 of approximately $160 million and is a leader in the global cephalosporins market, and is also a supplier of non-cephalosporin bulk actives, formulations, and nutraceuticals with exports to more than 75 countries.
The Apotex Group manufactures high-quality generic pharmaceuticals, used by millions of patients worldwide. Its product line includes oral solids, liquids, injectables, nasal sprays, ophthalmics and inhalation solutions.
Apotex Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned manufacturer of prescription drugs.
Through its sales and marketing headquarters in Weston, Florida, operations center in Indianapolis, and research facility in Lincolnshire, Illinois, Apotex Corp. is committed to providing safe and affordable generic medicines.
Products manufactured and marketed by the Apotex Group are sold in 115 countries around the world. For more information visit apotexcorp.com.
Posted by nannie (Member # 5250) on :