E-PHARMA Trento Italy
E-PHARMA is an Italian Contract Development and Manufacturing Organization (CDMO), highly specialized in SOLID ORAL DELIVERY FORMS
Comprehensive single-source provider from drug product development through commercial manufacture.
High level of outsourcing from dossier technical evaluation to private label manufacturing.
We independently develop new pharmaceutical products on the basis of our technology platforms, delivery forms and know-how.
We out-license our registration dossiers, fully developed in house, for the partners to register and apply for a Marketing Authorisation in their country/-ies with their own trademark.
Technologies
Effervescent formulations are solid immediate release forms that need to be dissolved in water at the time of administration.
Sublingual technology refers to the pharmacological route of administration by which drugs diffuse into the blood through tissues under the tongue.
Designed to disintegrate rapidly on contact with saliva and enable oral administration without water or chewing.
Soluble formulations are solide immediate release forms that need to be dissolved in water with rapid stirring at the time of administration.
Pharmaceutical Forms
- EFFERVESCENT TABLETS
- GRANULES FOR SUSPENSION
- EFFERVESCENT GRANULES
- SOLUBLE GRANULES
- ORALLY DISINTEGRATING GRANULES
- CHEWABLE TABLETS
- ORALLY DISINTEGRATING TABLETS
- SUBLINGUAL TABLETS
- SUBLINGUAL GRANULES
Immediate Packaging
Certifications
EU GMP
Certificate issued by the Italian Medicines Agency (AIFA)
Italian Health Authorities
Authorized by the Italian Health Authorities to produce pharmaceuticals and food supplements
Italian Health Authorities
Authorized by the Italian Health Authorities to use narcotic drugs or psychotropic substances and licence for drug precursors
FSI «SID&GP»
Authorized by the Ministry of Industry and Trade of the Russian Federation on GMP compliance
FDA registered
FDA registered for the US market of food supplements and for medical devices
TGA
TGA registered for the Australian market of food supplements
UNITED ARAB EMIRATES
United Arab Emirates registered for the market of food supplements
ISO 45001
ISO 45001 System certification on Health & Safety at workplace
FSSC 22000
FSSC 22000 Food Safety System Certification
HALAL
HALAL Certificate on production lines
KOSHER
KOSHER Certificate (product based)
Patents
Granulate for the formulation of orodispersible tablets
European Patent EP 2238974, exp. 2029 US
Patent granted US9861581, exp. 2030
New strengthened blister pack
European Patent EP 2353573, exp. 2030
US Patent granted US9850051, exp. 2035
Canada Patent granted CA2730464, exp. 2031
Anti-abuse pharmaceutical composition
Patent (Italy)102016000122469, exp. 2036
European Patent EP329939, exp. 2037 US
Patent granted US2018/0154002, published