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
Dexlansoprazole DR Capsule	BENTYL®	For the treatment of functional bowel/irritable bowel syndrome	P I
Dicyclomine HCl Capsules	Dexilant®	Erosive Esophagitis, GERD	P IV
Diltiazem ER Capsule	Cardizem® CD	Vasospatic Agina, Hypertension	P II
Diltiazem ER Capsules	Cardizem SR®	Indicated for the treatment of 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
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
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-029	Not Disclosed	Indicated to treat the symptoms of elevated IOP in patient with glaucoma.	P II
TWi-031	Not Disclosed	Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults.	P III
TWi-032	Not Disclosed	Epilepsy	P I