Doppel has two state-of-the-art manufacturing facilities at Cortemaggiore and Rozzano in Italy.
The closely integrated and synergistic capabilities and capacity at both sites guarantie business continuity and on-time-in-full (OTIF) service delivery.
The plant covers an area of 44.000 m2 and has personnel with extensive experience in developing, manufacturing and packaging of semi-solid and liquids, highly potent solid dosage forms and soft gelatin capsules.
Semi-solid and liquid forms (pharmaceutical and medical devices) are manufactured in majority, particularly:
Doppel Cortemaggiore has been inspected and approved by AIFA, Korea KFDA, ANVISA and Ministry of Health of Kenya Republic and is certified to manufacture both investigational and commercial medicinal products.
The site is also certified
ISO 14001 and OHSAS 18001 environmental and safety management system
ISO 13485 for medical devices
ISO 9001, ISO 22001 and IFS only for food department
The plant covers an area of 25.000 m2 and has staff with extensive experience in developing, manufacturing and packaging of non-sterile liquids, solid dosage forms and injectable products. Solid dosage forms include:
– Granules manufactured using conventional technologies such as wet granulation obtained by high shear mixing combined with fluid bed drying; or by dry granulation with a high throughput roller compactor machine. Granules can then be filled in sachets, hard gelatin capsules, tank caps or be compressed into tablets
– Uncoated and film coated tablets formulated as immediate or sustained release dosage forms made of single or multiple layers with one or more drugs in one dosage form. Coated tablets are produced using either water-based or organic-based film coating suspensions. Uncoated and coated mini and micro-tablets are also produced and the obtained bulk product can be filled into hard gelatin capsules.
– Sterile products as ampoules are manufactured either by aseptic processing or terminal sterilization.
– Probiotics are also produced in a fully segregated area.
The R&D division, with its pilot facilities approved by AIFA, is hosted at the site offering formulation and analytical methods development and manufacturing of clinical trial batches, as well as consultancy in regulatory affairs throughout the registration process to filing and also post-marketing variations.
Doppel Rozzano has been inspected and approved by AIFA, China FDA and Ministry of Health of Kenya Republic; and is certified to manufacture both investigational and commercial medicinal products. The site is also certified according to the environmental and safety management systems ISO 14001 and OHSAS 18001.