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ANI Pharmaceuticals, Inc.

http://www.anipharmaceuticals.com/

Latest From ANI Pharmaceuticals, Inc.

Aerie Misses Quick Path To Dry Eye Approval, But Is Still Moving Forward

AR-15512 missed the primary endpoints in a Phase IIb dry eye disease study that could have served as a pivotal trial, but Aerie’s drug hit enough signs and symptoms of the disease to justify a Phase III.

Clinical Trials Drug Approval Standards

FDA Accepts ANI’s Refiled Cortophin Gel

ANI Pharmaceuticals has announced that the refiled sNDA for its Cortrophin Gel has been accepted by the FDA with a target action date of 29 October 2021. The company said that it was continuing to strengthen its rare disease business leadership team and overall organization to drive the Cortrophin Gel launch preparation.

United States FDA

FDA Begins cGMP Reinspection Of Teligent’s Key Facility

Teligent is relying upon the FDA approval of its manufacturing capacity at Buena, New Jersey to reintroduce its products in the market and “significantly expand” its production capabilities within the sterile injectables segment. 

Generic Drugs Sales & Earnings

ANI Prepares For Cortrophin Launch

US-based ANI Pharmaceuticals is looking to strengthen its leadership team and strategize a commercial approach for the launch of Cortrophin Gel, as it anticipates FDA approval by 29 October 2021. ANI reported a 2.4% increase in its generics business.

Approvals FDA
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Company Information

  • Industry
  • Contract Research, Toxicology Testing-CRO
  • Services
  • Pharmaceuticals
    • Generic Drugs
  • Other Names / Subsidiaries
    • BioSante Pharmaceuticals, Inc.
    • Cell Genesys, Inc.
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