News & Highlights
Doppel Pharma CDMO and its commitment towards Rare Diseases and Orphan Drugs
Doppel perspective on Orphan drugs According to the US Food and Drug Administration (FDA), an orphan drug is defined as one "intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 people in the US" (which equates to approximately 6 cases per 10,000 of its population), "or meets cost recovery provisions of the act". [...]
Doppel Pharma CDMO delivers first commercial batches of generic temperature stable Nitisinone capsules to the USA
Milan, July 4th 2022 Doppel Pharma CDMO is pleased to announce that on June 24th, it has delivered to Dipharma the first commercial batches of generic temperature stable Nitisinone capsules to be commercialized in the USA. Nitisinone is used to treat adult and pediatric patients with a confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restrictions. Since its use as the [...]
Doppel Pharma CDMO delivered the first validation & Commercial batches of Ravidasvir
On March 8th Doppel Pharma CDMO delivered the first validation & Commercial batches of Ravidasvir, to be commercialized in Malaysia for the treatment of Hepatitis C. Hepatitis C is a viral infection that causes liver inflammation, sometimes leading to serious liver damage including cancer. Ravidasvir is an oral NS5A inhibitor discovered, owned and patented by Presidio Pharmaceuticals, USA. It was licensed to Egyptian drug manufacturer [...]
Meet Doppel-Dietopack in Berlin on March 30-31 at Pharma Contract Manufacturing.
Rocco Paracchini, CCO at Doppel-Dietopack, will walk you through our Technological and industrial capabilities as applicable to NCE, OTC, GX and nutraceutical (for humans and pets)
Welcome Sotax CE7
We are very proud to welcome Sotax CE7 Smart flow-through dissolution testing system a.k.a #USP IV apparatus or EP Flow-through cell in our labs! Doppel Farmaceutici R&D Unit consolidates his capability in drug release testing and in-vitro/in-vivo correlation (IVIVC) studies of poorly soluble, modified/extended release and low dose products. Complete flexibility on media volumes and repeatable positioning of virtually all dosage forms such as softgel capsules, semi-solids, [...]
Doppel Farmaceutici annuncia l’acquisizione di Dietopack.
E’ con orgoglio ed immenso piacere che Doppel Farmaceutici annuncia l’acquisizione del 90% di Dietopack, azienda emiliana tra le principali in Italia che sviluppa, produce e confeziona integratori, alimenti a fini medici e dispositivi medici per conto terzi. Con un fatturato di circa 10 milioni di euro e 60 dipendenti in totale, l'azienda di Medolla (MO) presidia l’intero ciclo della catena del valore: dallo [...]