Saneca Pharma – European Leader in Opiates and Controlled Substances | Globalk
Saneca Pharma, founded in the 1940s in Slovakia, began its journey as a morphine manufacturer. After being part of Sanofi’s Zentiva division between 1993 and 2013, the company was re-established as an independent entity, consolidating its position as a European leader in the manufacturing of opiates. Saneca has unrivalled expertise in controlled substances, specializing in the extraction, purification, and GMP production of opioid-derived APIs for analgesic use. Its industrial capacity and advanced know-how in controlled processes make it a strategic partner within the opioid API supply chain in Europe.
With unmatched expertise in controlled substances, Saneca specializes in developing and manufacturing opioid products.
Their fully integrated services—from contracts with local farmers to advanced technologies, stringent security measures, and a robust logistics network—enable them to manage the entire opioid production process, from farm to pharmacy.
Saneca currently produces 15 opioid APIs under GMP conditions, utilizing both extracted morphine and thebaine bases as well as fully synthetic processes. Their state-of-the-art technology and security protocols support the manufacture of various finished dosage forms, including tablets, capsules, granules, and syrups.
Saneca’s comprehensive opioid manufacturing services include:
- Partnering with farmers for poppy straw cultivation and harvesting.
- Cleaning, transporting, and storing poppy straw at their facility.
- Extracting and purifying morphine and other alkaloids.
- Transforming isolated alkaloids into APIs.
- Producing finished dosage forms based on opioids.
- Delivering products to customers.
Their catalog features a range of generic active ingredients and controlled substances, distributed in over 50 countries.
Production Excellence and Process Control at Saneca Pharma
The manufacturing plant in Hlohovec, Slovakia, is certified in Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). It features a dedicated quality team with qualified personnel overseeing batch release and supports a comprehensive range of manufacturing processes and activities:
- Equipment for diverse chemical reactions, purification ,operations,drying, sieving , micronization etc.
- Production of pilot batches, pre-validation, validation and commercial batches.
- In-process controls throughout the manufacturing stages.
- Stability studies to ensure product quality.
- Comprehensive documentation, including DMFs and supporting documents for CEP.