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U.S. FDA Approved ANDAs

To address the demand by patients in China for high-quality, affordable pharmaceuticals, CASI has acquired a portfolio of FDA-approved and FDA-pending ANDAs for generic products.

From this portfolio, CASI will prioritize a select subset of products to transfer to lower-cost manufacturing facilities in China and intend to submit CBE-30 supplement or Prior Approval Supplement (PAS) for these applicable ANDAs. CASI’s primary focus for these generic products is to accelerate their availability to patients in the greater China region.

Transferring the manufacturing to China will also allow CASI to avail itself to the evolving Chinese FDA (NMPA) 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 U.S. ANDA assets to strategic partners.

A list of the acquired ANDA products is provided below:

For the treatment of chronic hepatitis B virus infections

Product Approved
Entecavir tablets X
Tenofovir disoproxil fumarate (TDF) tablets 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
Heparin sodium for injection X
Methimazole tablets X
Nabumetone tablets X
Ondansetron HCL tablets X
Repaglinide tablets X
Tizanidine 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. NASDAQ-listed biopharmaceutical 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 have 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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