Active Ingredients
Saneca
Saneca Pharma is a company that was founded in the 1940s in Slovakia which started their journey as a morphine manufacturer. In 1993, they became part of the Zentiva division, a European Sanofi generic brand until 2013 when they went back to being an independent company.
Saneca has unparalleled experience in controlled substances, particularly in the development and manufacturing of opioid products. They offer completely integrated services: contracts with local farmers, a range of technologies, security controls and a logistical network that allows Saneca Pharma to take the opioid challenges from the farm to the pharmacy.
APIs
Currently, they make 15 API opioid products under GMP conditions and they are produced from a base of morphine and thebaine extracts and are completely synthetic. They have top level technology and security to offer an opioid manufacturing service in a wide variety of finished dosage forms from tablets and capsules to powders and syrups.
THEIR OPIOIDE MANUFACTURING SERVICES INCLUDE:
Cooperation with farmers to obtain poppy straw.
Poppy straw cleaning treatments after harvest in association with the farmers.
Transport and store of poppy straw in the Saneca Pharma plant.
Morphine extraction and other alkaloids and purification.
Alkaloids isolated from chemical transformation (from poppy straw) for the development and manufacturing of API
Production of finished pharmaceutical opioid forms
Product delivery to clients
ACTIVE INGREDIENTS
The manufacturing factory is located in Hlohovec (Slovakia) and is certified in GMPs and GDPs. It is formed by a skilled team of four people who are responsible for the batch releases and includes a wide spectrum of processes and manufacturing activities.
- Teams for different chemical reactions, purification operations, curing, sifting, micronization, etc.
- Manufacturing of pilot batches, prevalidation, validation and commercial batches.
- Process control during manufacturing.
- Stability studies.
- Documentation: DMP, CEP support documents.
