TWi Pharmaceuticals' Manufacturing Site for the Generic Version of Lidoderm(R) (Lidocane 5% patch) Passes US FDA cGMP Audit and Pre-Approval Inspection
TAIPEI, Taiwan, May 29, 2013 /PRNewswire/ -- TWi Pharmaceuticals, Inc., today announced that Teh Seng Pharmaceutical Mfg. Co. (Teh Seng), the manufacturing partner for its generic version of Lidoderm® (5% lidocaine patch) located in Taiwan, has completed the cGMP audit and pre-approval inspection (PAI) by US Food and Drug Administration (FDA) and been granted "acceptable" status under the FDA's regulatory guidelines. "We are pleased to know Teh Seng has received the 'acceptable' status upon the completion of cGMP audit and PAI by US FDA," said Calvin C. Chen, President of TWi Pharmaceuticals. "TWi has worked closely with our manufacturing partner on meeting FDA's regulatory requirement for our lidocaine patch product. Getting the 'acceptable' status not only shows TWi and its manufacturing partner's continuing commitment to the high standard production quality, but also brings TWi one step closer to getting the ANDA approval and launching this important product in the US."
Lidocaine patch is currently marketed under trade name Lidoderm® by Endo Pharmaceuticals Inc. in the US and has been approved for relieving post-herpetic neuralgia. According to IMS Health data, in 2012, the total sales figure of Lideoderm® in the US is over US$ 1.2 billion.
About TWi Pharmaceuticals, Inc.
TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high barrier generic prescription products ranging from oral controlled release dosage form to novel drug delivery systems including the utilization of nanoparticles, transdermal, and polymeric oral delivery systems. Leveraging its internal research and development capabilities, together with operational flexibility, process development, manufacturing and regulatory expertise, TWi Pharmaceuticals concentrates on products and technologies that present significant barriers to entry or offer Paragraph IV first-to-file or first-to-market opportunities in the United States. For more information of TWi Pharmaceuticals, please visit www.twipharma.com.
About Teh Seng Pharmaceutical Mfg. Co., Ltd.
Teh Seng Pharmaceutical is among the global leaders of topical patch manufacturing. Located in Tainan, Taiwan, the company has developed and manufactured over sixty patch products for various medical and cosmetic applications. The products are distributed in several countries across Asia, Europe and in the United States. For more information of Teh Seng Pharmaceutical, please visit www.tehseng.com
Michael L. Huang
Head of Investor Relations
SOURCE TWi Pharmaceuticals, Inc.