Grindeks JSC - Product Development and Global Contract Manufacturing of APIs and Final Dosage Forms

JSC Grindeks is the leading pharmaceutical company in the Baltics, specializing in research, development, manufacturing and sales of original products, generics and active pharmaceutical ingredients (APIs). Grindeks is able to offer a fully integrated set of services – from the pharmaceutical development stage to the final distribution of products and provide you with long term and customized contract manufacturing solutions.

Contracted research APIs

Grindeks has all the necessary resources for ensuring contracted research of APIs. R&D resources are involved in the development of new APIs according to cGMP and specific requirements of customers. Significant resources have been invested to introduce and establish modern standards in the quality assurance system, innovative laboratory equipment and production facilities.

Grindeks can offer complicated, multi-stage synthesis (5-10 stages) of APIs at reasonable prices, particularly for niche pharmaceutical products in gram to multi-kilogram quantities:

• Synthesis of GMP drug intermediates and APIs
• Peptides in small quantities
• Specific technologies: freeze drying, electro dialysis, Griniard reactions, catalytic hydrogenation, etc.
• Complete analytical support - HPLC (including UV, MS, LSD, refractometrical detection); NMR; DSC; PXRD; IR; UV; CHN analysis; atom absorption etc. including validation of methods in GMP or GLP-certified laboratories
• Development and optimization
• Process scale-up and optimization in pilot plant
• Custom manufacturing under cGMP including method validation and cleaning validation
• Stability studies under ICH guidelines
• Development of active substance master files (ASMFs) in CTD

API manufacturing

The Grindeks API manufacturing unit produces bulk pharmaceutical substances and pharmaceutical intermediates as well as performing production scale-up.

The core technologies cover the following types of reactions:

• Substitution
• Elimination
• Addition
• Regrouping
• Specialized reactions

Typical processes for the routine production are:

• Heating / cooling (from -30° C to +250°C)
• Autoclave processes (up to 40 tam)
• Rectification; extraction
• Crystallization; sedimentation / filtration
• Distillation in vacuum
• Saturation with gases
• Freeze-drying

Manufacturing scale:

• Stainless-steel and glass lined jacketed reactors from 250° to 1,600l
• Autoclave 160l
• Centrifuges (max load 250kg)
• Rectification columns
• Vacuum and pressure filters
• Shelf and conical dryers
• Evaporation equipment (10/hr to 50l/hr)
• Freeze-drying equipment

Separate production lines and cleaning validation are used to prevent cross-contamination.

Contract manufacturing of final dosage forms

Grindeks has made considerable investments in modernization of its plant for manufacturing of final dosage forms. We are able to offer high quality contract manufacturing services that are carried out in compliance with good manufacturing practice standard and an overall quality management system, which cover the whole cycle of manufacturing.

Continuous improvements and enlargement of the production capacities allow us to provide a full service of contract manufacturing – purchasing of raw materials, quality control, analysis, validation, manufacturing, packaging and logistics. Our plant, fitted with the latest technology ensures the manufacturing of high quality products – tablets, capsules and syrups.

Quality control, analyses and validation

The manufacturing is organized in compliance with the standards of a Good Manufacturing Practice certificate and coordinated with standard operating procedures. Grindeks’ plants have been inspected on several occasions both by co-operation partners and by pharmaceutical inspectorates from all over the world who have subsequently recognized their compliance to international quality standards.