Engineers Journal, December 5, 2017
With the commissioning of a 220m2 manufacturing unit dedicated to the synthesis of corticosteroids, Hovione, an independent API manufacturer, widens the range of services offered to the pharmaceutical industry.
Totally renovated in 2001 using state-of-the-art technology, the facility was the object of an FDA PAI inspection in June, for which no Form 483 was issued. The plant is suitable for the manufacture of corticosteroids and similar compounds (but not steroids with hormonal activity) under cGMP for oral, topical, inhalation and injectable administration.
With controlled personnel access as well as controlled materials flow, the unit produces INDs, NDAs and generic compounds in batches ranging from 1 to 100 kilos. Filtration, drying, milling, sieving, micronization and packing are carried out in 3 distinct class 10.000 clean rooms. Tri-clamped lines to transfer the crystallized reaction mixture into clean room conditions for filtration have been installed for speed and flexibility, allowing also for effective cleaning. Charging of solids is done in a closed circuit preventing contact of the product with the exterior through a high containment solids transfer valve. The site is further equipped with WFI and USP purified water loops.
Hovione has 40 years experience in corticosteroid chemistry. The company has expertise in over 75 different analogues and all processes are developed in-house. Hovione´s corticosteroid generic products include betamethasones, beclomethasones, clobetasol, dexamethasone and mometasone.
The new facility dedicated to corticosteroids enhances Hovione's capabilities in the development and manufacture of highly regulated multi-step APIs. Another building suitable for high potency compounds and for cytotoxics is currently under evaluation and design.
- Glass-lined: 1x 200 – 1x 400 – 1 x 1200 – 1 x 2000 – 1 x 5000
- Stainless steel: 2 x 2000 – 1 x 7500
- Monoplate filters
- Static bed dryers
- Micronization equipment
- Fluid bed dryers
- Vacuum tray dryers
- Sieving and Milling
Hovione is an international group dedicated to the synthesis of APIs and serving exclusively the Pharma industry. With FDA inspected plants in Europe and the Far East and sales offices in Hong Kong, Switzerland and New Jersey, Hovione is committed to the highest levels of service and quality. Hovione’s capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex multi-step chemistry of APIs under FDA and ICH cGMP standards.