ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Memantine Hydrochloride Extended-Release Capsules 7 mg, 14 mg, 21 mg and 28 mg. The current annual U.S. market for this product is approximately $127 million, according to IQVIA.

For the first quarter 2020, ANI reports:

Q4 2019 ANI Pharmaceuticals Inc Earnings Call

ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Omega-3-Acid Ethyl Esters Capsules USP, 1 gram. The current annual U.S. market for this product is approximately $110 million, according to IQVIA/IMS Health.

Q1 2020 ANI Pharmaceuticals Inc Earnings Call

ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Polyethylene Glycol 3350, 17g/Packet (PEG-3350). The current annual market for this over the counter (OTC) product is approximately $21 million, according to IQVIA. This launch represents ANI's fourth new drug introduction in 2020.

Image source: The Motley Fool. ANI Pharmaceuticals Inc (NASDAQ: ANIP)Q1 2020 Earnings CallMay 8, 2020, 8:30 p.m. ETContents: Prepared Remarks Questions and Answers Call Participants Prepared Remarks: OperatorGood morning, everyone, and welcome to ANI's First Quarter 2020 Earnings Call.

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To the annoyance of some shareholders, ANI Pharmaceuticals (NASDAQ:ANIP) shares are down a considerable 38% in the...

ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP), an emerging leader in the specialty pharmaceutical industry, today announced that it has submitted a prior approval supplement (PAS) to the Endocrinology Division at the FDA for re-commercialization of Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (80 U/mL). The current annual market for Cortrophin® Gel is approximately $950 million and has only one competitor. Cortrophin® Gel was originally approved by the FDA in 1954 and last used in patients in the 1980s. Cortrophin® Gel has over 54 indications on its previously approved label, including but not limited to acute exacerbations of multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and ulcerative colitis.

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ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that the U.S. Food & Drug Administration ("FDA") has accepted its supplemental new drug application ("sNDA") for Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (80 U/mL). The FDA set a PDUFA goal date of July 23, 2020.

ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announced today that the Company plans to release its first quarter 2020 financial results on Thursday, May 7, 2020, before the opening of the U.S. financial markets. The earnings press release will be accessible through the Investor Relations section of the Company's website, www.anipharmaceuticals.com.

It's been a mediocre week for ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) shareholders, with the stock dropping 11% to...

Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks.

ANI (ANIP) delivered earnings and revenue surprises of 16.85% and 0.76%, respectively, for the quarter ended March 2020. Do the numbers hold clues to what lies ahead for the stock?

ANI (ANIP) delivered earnings and revenue surprises of -8.47% and -6.32%, respectively, for the quarter ended December 2019. Do the numbers hold clues to what lies ahead for the stock?

ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that Arthur S. Przybyl will depart as President and Chief Executive Officer on May 10, 2020. The Board of Directors has retained a nationally recognized executive search firm to lead the search for a new President and Chief Executive Officer.

Shareholders in ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) had a terrible week, as shares crashed 22% to US$48.01 in the...

ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Cortrophin® Gel. Upon its preliminary review, the FDA determined that certain portions of the Chemistry, Manufacturing and Controls section in the sNDA were not sufficiently complete to permit a substantive review. ANI will seek immediate guidance, which potentially includes requesting a Type A meeting with the FDA, to clarify and respond to the issues identified in the RTF letter.