The Israeli company has 30+ years of focus on complex chemistry and uncompromising culture of quality. It offers a variety of tailor-made solutions including: excellent process and analytical development, novel routes of synthesis, material solid state and physical properties design, regulatory expertise, FDF forward integration solutions, Paragraph IV challenge partnerships, contract development & manufacturing services. Looking for partners to help develop and market their product globally.
Founded in Israel in 1987, the company develops, manufactures and markets Active Pharmaceutical Ingredients (API) and Finished Dosage Forms (FDF) for generic and branded pharmaceutical companies in more than 50 countries.
The company offers over 30 years of focus on complex chemistry and uncompromising culture of quality with exemplary regulatory compliance track record.
The company's 350 employees in Israel work in Ramat Hovav and Bnei Brak. With the main production plant being in the Ramat Hovav Industrial Zone in the Negev Desert. The company also has subsidiaries outside Israel in India and the U.S.
As of 2012, the company holds 25 proprietary patents and has filed for many more. They have full current Good Manufacturing Practices (cGMP) production, from grams to multi-ton, and is fully compliant with the regulatory requirements of leading health authorities including U.S. Food and Drug Administration (FDA), the United Kingdom’s Medicines Control Agency, Australia’s Therapeutic Goods Administration, and Canada’s Health Protection Branch.
The company is looking for manufacturing agreement and joint venture agreements, to help penetrate new markets around the world, to develop and grow the company.
- Specific area of activity of the partner: The company is looking for manufactures to develop and market pharmaceutical products to help spread the company's products across different regulatory markets (e.g. US, EU and Japan). Through this manufacturing agreement or joint venture agreement, the company can begin to grow and expand its sales in the process.
A world-class developer and manufacturer of high-quality Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF) drugs for the branded and generic pharmaceutical industries.
Products comply with the highest regulatory requirements of USFDA, EU, PMDA, TGA, KFDA, ANVISA and other leading health authorities.
Leading R&D capabilities and regulatory expertise with 175 DMFs worldwide.
The company's manufacturing facility has a wide range of multi-purpose manufacturing capabilities from lab-scale (grams) through pilot scale (kgs) and up to multi-ton commercial quantities including complex High-Potency pharmaceuticals, Corticosteroids and Cytotoxic compounds.
The company employees possess great strength in complex chemistry, patents and in-depth regulatory expertise and use this expertise to offer tailor-made solutions to meet the individual requirements of customers.
The company is looking to partner over the development and the marketing of Active Pharmaceutical Ingredients and Finish Dosage Forms (drugs) for the different regulatory markets (e.g. US, EU and Japan)
Already on the market - 36 commercial APIs, 5 commercial FDFs currently sold to More than 300 generic and branded pharmaceutical customers in over 50 countries. The company also have a wide range of pipeline products that are currently under development.
Patent(s) applied for but not yet granted,Patents granted
Clasificado como: Manufactura Industrial \ Ciencias de la vida \ Industria
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