TWi- insights into complex technologies and difficult-to-manufacture generics

TWi has already successfully file several ANDAs with US FDA and has 15-20 on going oral and nonoral projects in its current R&D pipeline. To ensure TWi's future success, TWi has adopted the following product research and development strategies:

Oral Formulation
Continuing Development of Control Release Oral High Barrier Generics for US

  • Since becoming Anchen, Inc.'s Taiwan R&D subsidiary in 2006, TWi had successfully developed and transferred over 20 control release oral High Barrier Generics to Anchen, Inc.
  • With experience and know-how in developing the High Barrier Generics of high technical barriers while being Anchen, Inc.'s subsidiary, TWi has file several its own ANDAs for oral control release products with US FDA since spinning off from Anchen, Inc. in 2010.
  • In the future, TWi will continue to develop control release oral High Barrier Generics. To better compete against other world-class High Barrier Generics pharmas, TWi will take advantage of its expertise and past experience in managing bioequivalent studies to shorten the product development time in order to obtain FTF and FTM opportunities.

Nonoral Formulation
Developing Parental and Transdermal Platforms to Expand Product Bandwidth

  • TWi adopts a two-stage development strategy for parenteral products. Initially, TWi will develop the formulation internally and collaborate with contract manufacturer for pilot and/or commercial production. When TWi has reached an economic scale in its parental products, TWi will build its own pilot and commercial sterile production facilities for further solidify its competitive advantages.
  • TWi has collaborated with other Taiwan-based pharmaceutical company to co-develop transdermal products for US. By forming alliance with pharmaceutical companies with different formulation expertise, TWi can ensure its competitive advantage in alternative formulation development over other high barrier generic pharmas.

Approved ANDA

Generic Name Brand Name Indication Type
Cyclobenzaprine ER Capsule Amrix® Muscle Relaxant P IV
Donepezil 23mg tablet Aricept® 23mg Alzheimer's Disease P I
Guanfacine ER Tablet Intuniv® ADHD P IV
Megestrol Acetate 125mg/ml Megace® ES Anorexia, Cachexia, or significant unexplained weight loss for AIDS patients P IV FTF
Nifedipine ER tablet Procardia® XL Vasospatic Agina, Hypertension P II

ANDA Filed

Generic Name Brand Name Indication Type
Cyclosporine ophthalmic emulsion Restasis®  Chronic Dry Eye P IV
Dexlansoprazole DR capsule Dexilant® Erosive Esophagitis, GERD P IV
Diltiazem ER capsule Cardizem® CD Vasospatic Agina, Hypertension P II
Lidocaine 5% patch Lidoderm® Post-herpetic Neuralgia P IV
Oxcarbazepine ER tablet Oxtellar XR® Epilepsy P IV
Testosterone Gel, 1.62% Androgel® 1.62% Hypogonadism   P IV
Testosterone Transdermal Solution, 30 mg/1.5 mL Axiron® Hypogonadism P IV
TWi-011 Not Disclosed Hypertension P II
TWi-015 Not Disclosed Depressive Disorder P III
TWi-016 Not Disclosed Multiple Sclerosis P IV
Zolpidem tartrate sublingual tablet Intermezzo® Insonmia P IV

 

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