Teh Seng’s generic Lidoderm manufacturing facility in Taiwan successfully completes FDA cGMP audit

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.

Source:

TWi Pharmaceuticals, Inc.

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