Saneca Pharmaceuticals
Pharmaceutical contract manufacturing company
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API Production

API Product List (click here)
Narcotic Products Capabilities:
  • Morphine based narcotic API’s
  • Thebaine based narcotic API’s
  • Synthetic based narcotic API’s
  • Backwardly integrated poppy straw
  • 10 narcotic API’s backed by CEP’s
  • Ability to handle control drugs through supply chain
  • Fully integrated supply chain can take your product from farm to pharmacy
  • Global supply
API R&D
  • Optimising of a selected synthetic route
  • Analytical method development
  • Evaluating scale-up and safety
  • Producing pilot batches
  • Preparing validations including cleaning validations
  • Producing pre-validation and validation batches
  • Continuous improvement of technologies and processes
  • Stability testing at all stages
  • Risk analysis, REACH agenda
  • Synthesising and characterising impurities
  • Compilation of registration documentation CEP, DMF
API Production Capabilities
  • Multi purpose commercial production facilities
  • Pilot plant & cGMP Kilolab
  • Total reactor capacity of 190m³
  • Broad range of production technologies and chemical expertise
  • 141 glass-lined and stainless steel vessels ranging from 60 to 6.000 liters
  • Batch size: approx. 0,5 to 700 kg/batch
  • Milling and micronization equipment
  • QC testing
  • Controlled substance license
  • Human API and Veterinary API EU GMP
API Production Technologies
  • Catalytic processes
  • Separation solid-liquid
  • Separation liquid-liquid
  • Absorption
  • Adsorption
  • Distillation, rectification
  • Crystallization
  • Drying
  • Particle size modification
  • Recycling of solvents
  • Extraction and Isolation from natural MT raw material
R&D Warehousing and Distribution
Saneca Pharmaceuticals
© Saneca Pharmaceuticals 2021

Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec

Slovakia

e-mail: info @ saneca.com

Infoline: +421 33 736 1111

FDF info: +421 33 736 2216

API info: +421 33 736 2813

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