API – Manufacturing services

Agile approach… through dynamic operations

Saneca Pharma has over 70 years’ experience in manufacturing active pharmaceutical ingredients (API’s) .

Whether you access our standalone API manufacturing service or require API in conjunction with our finished dosage form  manufacturing capabilities, Saneca Pharma is a CDMO partner that can add value to your project.

Our expert team currently manufactures over 30 different APIs on-site, distributing to over 50 countries around the world. You can access products from our own generic opiate  API manufacturing  portfolio or use our custom API manufacturing services.

Due to its range of facilities and technologies, our site is highly suited to the production of complex, multi-step products. We also have the high- level security required to manufacture controlled drugs,  in particular Saneca Pharma´s range of opiate APIs.

All of our facilities comply with European Good Manufacturing Practice (cGMP).  The Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Food and Drug Safety (MFDS) have inspected our sites and given their seal of approval, so Saneca Pharma can meet your supply needs in Japan and Korea, too.

Our expertise
Saneca Pharma´s  experienced team of synthetic and analytical chemists are committed to delivering focused solutions to your API manufacturing challenges, complemented by our highly experienced regulatory professionals and supply chain experts to ensure all aspects of your API project are handled with expert care.

Our API manufacturing services incorporate a wide range of processes including:

  • equipment for different chemical reactions, purification, isolation, drying, sieving, milling and micronisation
  • manufacturing  pilot, pre-validation, validation and commercial batches
  • in process control and technological supervision through all phases of manufacturing
  • cleaning, verification and validation
  • stability testing
  • REACH agenda
  • preparing DMF and CEP support documentation

To find out more about our API manufacturing services, just phone us at
+421 33 736 2813 or e-mail api@saneca.com.

 

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