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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, to improve off-patent drug products, and developing generic versions of controlled release drug products with high barriers to entry. Elite has four ANDA products partnered with TAGI Pharma; one ANDA has launched, two ANDAs are in the process of a manufacturing site transfer and an additional ANDA is currently under review by the FDA. Elite also manufactures Lodrane D® and receives royalties for Lodrane D®, an allergy product partnered with ECR Pharmaceuticals (“ECR”), a wholly owned subsidiary of Hi-Tech Pharmacal (“Hi-Tech”). Elite`s lead pipeline products, ELI-216, a once-daily abuse resistant oxycodone, and ELI-154, a once-daily oxycodone, are novel sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also has partnered with Mikah Pharma to develop a new product and with Hi-Tech Pharmacal to develop an intermediate for a generic product.
Jaguar Animal Health is a company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals. Our products are designed with a thorough understanding of not only species-specific health issues, but also market practices, the economics of current treatment strategies, competitive dynamics, government initiatives, such as concern for extensive antibiotic usage, and effective channels for new product introductions. In addition to Canalevia™ for dogs and Neonorm™ for preweaned dairy calves, we are developing formulations of these products across multiple animal species and market channels. Our management team has significant experience in gastrointestinal and animal health product development. This experience includes the development of crofelemer for human use, from discovery and preclinical and clinical toxicity studies, including the existing animal studies to be used for Canalevia™ regulatory approvals, through human clinical development. Our team also includes individuals who have prior animal health experience at major pharmaceutical companies, including Ciba-Geigy Corp., now Novartis International AG, SmithKline Beecham Corporation, now GlaxoSmithKline LLC, and the animal health group of Pfizer Inc., now Zoetis Inc.
IriSys Inc is a San Diego, CA-based company in the Healthcare, Pharmaceuticals, and Biotech sector.
MANUFACTURING Philosophy The TRC team understands that the actions required to be a successful pharmaceutical manufacturer are more than just completing repetitive and highly detailed tasks accurately; it is the understanding that we...
Ion Labs is a cGMP Certified & FDA registered private label and contract manufacturer of dietary supplements, OTCs, pet supplements, and skin care products.