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 non-oral projects in its R&D pipeline. To ensure TWi's future success, TWi has adopted the following research and development strategies:

Oral
Continuing Development of Control Release Oral Niche Generics

  • Since being Anchen, Inc.'s Taiwan R&D subsidiary in 2006, TWi had successfully developed and transferred over 20 control release oral Niche Generics to Anchen, Inc.
  • With experience and know-how in developing the Niche 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.
  • Going forward, TWi will continue to develop control release oral Niche Generics. To better compete against other world-class Specialty Generics companies, 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.

Semi-solid
Developing Transdermal and other semi-solid Platforms to Expand Product Bandwidth

  • TWi currently has 2 transdermal ANDA filings under US FDA's review and provides all the support to the clinical trial and manufacturing capacity for TWi Bio's orphan drug (AC-203). TWi also continues to look for M&A opportunities to further strengthen the portfolio.

Ophthalmic
Acquiring facility to shorten learning curve

  • In addition to internal efforts in developing ophthalmic products, TWi intends to expand the portfolio in a more effective and efficient way with secured capacity and capability by acquiring the existing facilities with experienced talents of Synpac-Kingdom in 2017

Other Complex
Working through partnership to accumulate the R&D capabilities

  • TWi also plans to engage in other complex dosage forms, such as injection and inhalation. By leveraging external resources from other leading companies in Taiwan or overseas, TWi is able to accelerate in-house R&D capabilities by strategic partnership to solidify its competitive advantages.

Approved ANDA

Generic Name Brand Name Indication Type
Bupropion HCl ER Tablet Wellbutrin XL® Depressive Disorder P IV
Cyclobenzaprine ER Capsule Amrix® Muscle Relaxant P IV
Diltiazem ER Capsule Cardizem® CD Vasospatic Agina, Hypertension P II
Dimethyl Fumarate DR Capsule Tecfidera® Multiple Sclerosis P IV
Donepezil 23mg Tablet Aricept® 23mg Alzheimer's Disease P I
Fenofibric Acid DR Capsule Trilipix® Reduce Triacylglycerol P IV
Fluphenazine HCl tablet Prolixin® Management of manifestations of psychotic disorders P I
Guanfacine ER Tablet Intuniv® ADHD P IV
Guanfacine Tablets TENEX Management of hypertension P I
Megestrol Acetate 125mg/ml Megace® ES Anorexia, Cachexia, or Significant Unexplained Weight Loss for AIDS Patients P IV FTF
Metformin Hydrochloride Extended-Release Tablets Fortamet Type II Diabetes, NIDDM P IV
Mycophenolic Acid DR Tablets Myfortic Prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids. P II
Nifedipine ER Tablet Procardia® XL Vasospatic Agina, Hypertension P II
Oxcarbazepine ER Tablet * Oxtellar XR® Epilepsy P IV
Propafenone Hydrochloride Extended-Release Capsules Rythmol SR Ventricular Tachycardia P II
Sevelamer Carbonate Tablets Renvela® Control of serum phosphorus in patients with chronic kidney disease on dialysis PII/III/IV
Terbutaline Sulfate Tablets Brethine Bronchospasm for >12-year-old P II
Testosterone Gel, 1.62% Androgel® 1.62% Hypogonadism   P IV
Testosterone Transdermal Solution, 30 mg/1.5 mL Axiron® Hypogonadism P IV

*Received US FDA Tentative Approval

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
TWi-023 Not Disclosed Treatment of inflammation and pain associated with ocular surgery. P II
TWi-024 Not Disclosed Control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. P IV
TWi-027 Not Disclosed for the treatment of functional bowel/irritable bowel syndrome. P I
TWi-028 Not Disclosed for the treatment of functional bowel/irritable bowel syndrome. P I
TWi-029 Not Disclosed Indicated to treat the symptoms of elevated IOP in patient with glaucoma. P II

 

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