LaborMed Pharma - Cardiovascular Medicines

LaborMed Pharma SA is an integrated, commercially-focused pharmaceutical company that produces a wide range of quality, affordable generic medicines. With excellent R&D capabilities, world class in-house bioequivalence facilities, low cost manufacturing and a strong distribution network, LaborMed Pharma is one of the largest independent generic companies in Romania and a top supplier of cardiovascular medicines for the domestic market.

NEW EU GMP COMPLIANT PRODUCTION AND RESEARCH FACILITY

The result of an €8 million Greenfield investment, LaborMed's new production and research facility in Bucharest is due to open in 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. Manufacturing capacity will exceed 1.5 billion tablets and capsules per year.

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

COMPUTER-ASSISTED HVAC

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

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

CONTRACT MANUFACTURING CAPABILITIES

Our contract manufacturing capabilities include oral solid dosage forms such as tablets, film coated tablet (immediate and extended release) and hard-shell capsules.

PHARMACEUTICAL CONTRACT SERVICES

• Stability testing
• Analytical methods validation
• Bioanalytical studies for bioequivalence

PRODUCT PORTFOLIO AND COMMERCIAL CAPABILITIES

LaborMed Pharma portfolio includes 80 products registered in Romania, covering seven therapeutic areas. 30 of our products are also authorized in several Eastern European countries. Portfolio enlargement is directed to the most attractive market segments and the development of value-added generics.

So far, LaborMed Pharma focused on launching products for the Romanian domestic market, which is the major source of the sales revenue. Employing a field force of 80 people and with its own integrated distribution unit the company is an important player on the fast growing Romanian pharmaceutical market.

WORLD-CLASS RESEARCH, ANALYSIS AND CONTROL LAB

LaborMed Pharma's first-to-market strategy is supported by strong R&D and regulatory capabilities. The research, analysis and control lab is certified ISO/CEI 17025:2001 and employs over 40 people. Product dossiers are being upgraded in EU CTD format, as an element of the large process of harmonization with EU directives.

Partnering opportunities

• Product in-licensing for the Romanian market
• Product out-licensing: EU registration and distribution agreements
• Product co-development