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Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products, improving off-patent drug products, and developing generic versions of controlled release drug products with high barriers to entry. With four ANDA products partnered with Tagi Pharma, Elite is making strides in the pharmaceutical industry. Elite also manufactures Lodrane D® and receives royalties for this allergy product partnered with ECR Pharmaceuticals, a wholly owned subsidiary of Hi-Tech Pharmacal. Their lead pipeline products, Eli-216 and Eli-154, are novel sustained-release oral formulations of opioids for chronic pain treatment.
Elite Pharmaceuticals announced FDA approval for its generic Methotrexate Sodium 2.5 mg tablets. This approval relates to an Abbreviated New Drug Application (ANDA) and adds to Elite's portfolio of niche generic products. The generic Methotrexate, classified as an antimetabolite, will be marketed under Elite Laboratories. According to IQVIA, the generic market for Methotrexate had annual sales of $64.3 million for the twelve months ending March 2024. Elite Pharmaceuticals focuses on developing, manufacturing, and distributing immediate-release and controlled-release solid oral dose products, operating from a cGMP and DEA registered facility in Northvale, NJ.
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