Friday 24 July, 2009

Generic Pharma Press Releases

Rivastigmine 1.5, 3, 4.5 and 6 mg capsules & 2 mg/ml solution: Generic player Synthon announced (in a press release Here ) that Synthon has successfully completed multiple decentralized procedures (DCP) for Rivastigmine. Regulatory clearance has been obtained for Synthon's product in nearly all European countries. Registration has been obtained for multiple dosage forms including capsules (1.5, 3, 4.5 and 6 mg) and an oral solution (2 mg/ml). Synthon' s Rivastigmine capsules and oral solution are a fully generic and bioequivalent version of the brand product Exelon®.

Ranbaxy’s manufacturing facility got cGMP compliance nod from MHLW- JAPAN Indian Pharma giant Ranbaxy Laboratories Limited (Ranbaxy) announced (in a press release Here ) that the Ministry of Health and Labour Welfare (MHLW-Japan), have issued a Good Manufacturing Practice (GMP) certificate for its non-sterile manufacturing site located at Dewas (India).

Ran-Simvastatin (Simvastatin) 5 mg, 10 mg, 20 mg, 40 mg and 80 mg tablets: Indian Pharma giant Ranbaxy Pharmaceuticals Canada Inc. (RPCI) has received approval in Canada to manufacture and market Ran-Simvastatin 5 mg, 10 mg, 20 mg, 40 mg and 80 mg tablets (Simvastatin) from Health Canada, Therapeutic Products Directorate (TPD). (Press release from Ranbaxy Here )

Haloperidol Tablets USP, 10 mg and 20 mg: The USFDA approval to Mylan ANDA for Haloperidol Tablets USP, 10 mg and 20 mg (as reported by Mylan in press release Here)

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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