LaborMed Pharma - Cardiovascular and Generic Medicines

LaborMed Pharma is an integrated, commercially-focused Romanian pharmaceutical company that produces a wide range of quality, affordable generic medicines. We boast of excellent R&D capabilities, world-class in-house bioequivalence facilities, low-cost manufacturing capabilities and a strong distribution network.

LaborMed Pharma owns two manufacturing facilities for oral solid forms with a total yearly capacity of 400 million tablets and capsules. The equipment in our production flow allows for the preparation of tablets and capsules in two methods - wet granulation and direct compressible mixing and our products can be packaged in aluminium / aluminium or PVC / aluminium blisters.

TECHNOLOGICAL, ANALYTICAL AND PHARMACOLOGICAL RESEARCH

LaborMed Pharma considers its own research and development activity to be a strategic process. In order to create current generic medicines, with characteristics similar to those of reference products, the company undertakes in-depth studies of a technological, analytical and pharmacological nature. The objectives pursued include:

• The improvement of the existing pharmaceutical formulas on the basis of current manufacturing observations
• The development and validation of analytical methods, in keeping with the latest version of internationally-circulated pharmacopoeias for the quality and quantity assessment of raw materials, intermediate and finished products
• Stability studies of the finished products
• Pre-formula studies following the determination of pharmacotechnical parameters of the active substances and excipients
• Drafting new pharmaceutical formulas and schemes of the technological processes, and assuring the transfer of technology at laboratory level, pilot station and industrial production respectively
• Bio-equivalence studies for establishing the therapeutic equivalence of LaborMed's products in with reference products
• Monitoring of products manufactured in the period of post-authorisation in point of adverse reactions and safety in use

SUPERIOR ANALYSIS TECHNIQUES

The physical, chemical and microbiological control laboratory plays an important role in attaining these objectives. Our highly competent expert team and the last-hour equipment allow the utilisation of top-of-the-line analysis techniques, such as:

• High-Performance Liquid Chromatography (HPLC)
• Gas-Chromatography (GC)
• Liquid Chromatography and Mass Spectrometry (LCMS)
• Infra-red spectrophotometry with Fourier transformation (FR/IR) as well as ultraviolet-visible (UV-VIS)
• Dissolution
• Particle counting and volumetric air sampling (for the monitoring of clean areas)

NEW EU GMP-COMPLIANT PRODUCTION AND RESEARCH FACILITY

An €8 million greenfield investment resulted in a new production and research facility, located in Bucharest, Romania. This facility is due to open during the first quarter of 2007. Designed and built in compliance with the EU GMP, the new plant boasts state-of-the-art technologies and the highest quality standards. The manufacturing capacity will exceed 1.5 billion tablets and capsules per year.

In the new facility, the contamination risks are minimal, following the cautionary measures taken for each of the four potentially contaminating factors: fresh air, compressed air, pure water and the surface of the production equipments. The quality of the inner environment has been ensured by the highest quality system available, the computer-assisted HVAC.

STERILE CONTRACT MANUFACTURING FACILITIES

A class 1-2-1 compressor supplies the compressed air and all equipments requiring this type of air are provided with sterile filters. The pure water is monitored following strict norms. Equipment is made of stainless steel type AISI 316L, a neutral sort in contact with the active substances. The qualified utilities (HVAC, pure water and compressed air), as well as the unqualified utilities (technological water, tap water, sanitary water), are provided with control and monitoring units.

All units related with the manufacturing process (production, storage, analytic lab, microbiologic lab, the energetic block and the administrative area) are networked, which ensures detailed monitoring of every stage of the process.