Final dosage
form research and
development

At Olpha, we study and conduct various solid oral dosage form development (tablets, capsules, powder dosages). We develop the finished dosage forms at newly constructed and modern research laboratories with access to all state-of-the-art instruments and facilities for the development of finished dosage forms and analytical support. In the drug research and development process, we employ the modern design of experiments (DoE) approach.

The laboratory of finished dosage forms features also a pilot section, where we perform scaling works of the developed technologies and where we can manufacture small finished product series, including final packaging. We strictly observe all principles of Good Manufacturing Practice.

Analytical laboratory

Equipment-based
research

HPLC-UV, HPLC-MS/MS, GC-FID, GC-MS, GC-HS-FID, TLC
Titration (aqueous, non-aqueous, Karl Fischer, argentometry, precipitation)
UV, IR, Optical rotation
Laser light diffraction

Method-based
research

Identification
Assay
Residual solvents
Related substances, genotoxic impurities and nitrosamines (from ppb level)
Dissolution of FDF

Task-based
research

Method development, validation, verification, transfer
Organic synthesis laboratory

Task-based
research

Development of chemical processes for obtaining new AFVs
Conducting pre-exploratory laboratory research
Scaling up chemical processes from 10 mL to 6 L
Determination of process calorimetric parameters
Transfer of AFV synthesis processes to production
Synthesis of AFV impurity standard substances
Inspection of regulated raw materials from new suppliers
Determination of critical quality attributes
Defining critical process parameters
Separation and identification of impurities
Investigation and evaluation of impurity transfer
Assessment of the presence of mutagenic, genotoxic and nitrosamine impurities
Production

Executing a wide
spectrum of production

Formulation development and optimisation (for tablets, capsules, sachets)

Production of scalable series, i.e. from pilot series to validation series.

Execution of drug and excipient compatibility studies

Transfer of the developed technology to production

Let's work together
to bring healthier life
within reach

Olpha is open to pharmaceutical co-development, contract manufacturing and out-licensing

Cooperate with Olpha

Media

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Business

For distributors and business partners

Social Initiatives

For social causes and potential projects

Careers

For open positions and career opportunties

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