CASI Pharmeceuticals

U.S. FDA Approved ANDAs

To address the demand in China for high-quality, affordable generic pharmaceuticals, CASI has acquired from Sandoz (a Novartis company) 25 U.S. FDA approved ANDA generic products and 4 pending ANDA submissions, and acquired from Laurus Labs Limited., Tenofovir disoproxil fumarate (TDF) indicated for the treatment of hepatitis B virus (HBV). A list of the acquired ANDA products provided below.

CASI will prioritize a select subset of products from the portfolio and begin work immediately on transferring these products to lower cost manufacturing facilities in China and contemplates submitting CBE-30 supplement or Prior Approval Supplement (PAS) to the approved/pending ANDAs as soon as possible. CASI’s primary commercial focus for these generic products is the China market. Transferring the manufacturing to China will also allow CASI to take advantage of the evolving Chinese FDA (CFDA) rules expected to streamline and accelerate the approval process for these high-quality generic products. CASI intends to develop and market on its own priority products from the portfolio and may partner the remaining US ANDA assets to strategic partners. U.S. ANDAs.

Many of the acquired U.S. ANDA products are approved for indications that represent large potential commercial markets in China such as entecavir for hepatitis B, the anti-hypertension products bisoprolol and hydrochlorothiazide-telmisartan combination, repaglinide for type 2 diabetes, desvenlafaxine for depression and the short-acting muscle relaxant tizanidine.

For the treatment of Hepatitis B Virus (HBV)

Product Approved
Entecavir tablets X
Tenofovir disoproxil fumarate (TDF) X

Product Approved
Benazepril tablets X
Bisoprolol fumarate tablets X
Burprenorphine HCL Sublingual tablets X
Cefprozil tablets X
Cilostazol tablets – 50mg X
Cilostazol tablets – 100mg X
Desvenlafaxine ER tablets X
Diclofenac potassium 50mg tablets X
Diclofenac sodium DR 25mg, 50mg tablets X
Diclofenac sodium DR 75mg tablets X
Econazole nitrate cream X
Epinastine HCl Ophthalmic Solution X
Heparin sodium for injection X
Lisinopril tablets and Lisinopril BPP tablets X
Methimazole tablets X
Midodrine tablets X
Nabumetone tablets X
Naratriptan tablets X
Ondansetron HCL tablets X
Repaglinide tablets X
Ribavirin capsules X
Spironolactone tablets X
Tizanidine tablets X
Triamterene and hydrochlorothiazide combination tablets X

Product Pending
Aripiprazole tablets X
Bepotastine Ophthalmic Solution X
Bromfenac Ophthalmic Solution X
Telmisartan and hydrochlorothiazide tablets X

About Us

CASI is a U.S. based pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, U.S., and throughout the world. We are a NASDAQ-listed company, with offices in Rockville, Maryland, and a wholly owned subsidiary in Beijing, China through which substantially all of our operations are conducted.

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