“Our experience in handling the launches of high-potency products and our CMO commercial offer today greatly differentiate us from the competitors,” explains Product Development Director Dr. Denis Gicquel. “Over the years, we have been able to develop a unique range of skills and tools such as preliminary risk assessment, state-of-the-art development and manufacturing facilities, while at the same time we have introduced very advanced EH&S policies.” The company portfolio encompasses hormones (progestatives, estrogens, and others), anti-hormone pharmaceutical products, selective estrogen receptor modulators (SERMs), allergens and controlled substances.
“Sometimes, we just have a mandate with a formula and only have to implement the manufacturing and logistics to include purchasing,” explains Quality and EH&S Director Dr. Emmanuel Couquelet.
“In other cases, only the active molecule is known, and we carry out the complete pharmaceutical development through to the final packaging, and this can sometimes include so-called ‘Phase IV’ studies. All our products on site are high-potent, and the industrial and regulatory strategy has been discussed with the regulatory agency AFSSAPS in France. With high-potency products, small to very small quantities have a strong therapeutic effect, and high doses can be lethal. Our drugs are used to treat cancer, and we produce steroids to provide relief during menopause as well as birth control pills. Therefore, safety is crucial and a top priority in all our business dealings. We have to ensure that every product is in full compliance and completely respects environmental constraints.”
At present, OSNY PHARMA focuses on oral dosage forms, such as pellets, tablets, capsules, powders and semi-solids. The company is well experienced in wet granulation, dry mixing and direct compression, coating and spray-drying and ensures low dose formulation, low solubility, poor bio-availability and modified-release formulation.
OSNY PHARMA services the big pharmaceutical firms as well as startup businesses. Around 50% of the revenues come from products developed or sold by customers in Europe, the rest from overseas.
At present, OSNY PHARMA is expanding into the US market. Founded in 1950, the company was then rooted in the development and production of hormonal products. With a staff of 160, the company now is a service provider.
“Currently, we are also researching potential contracts in liquids and in steriles” says Commercial Development Manager Kheireddine Larebaa. “We will continue to adapt our service portfolio to the needs of our clients. Our production layout is modular and can be adjusted to the individual customer needs fully respecting c- GMP compliance in high containment up to ‘Class 5’ regulatories.”
“We will also keep our focus on high-potent compounds and stay true to our original slogan Your partner for your highly potent projects,” adds Mr. Larebaa.
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