27.12.2012

Pharmaceutical company OOO "NPF "Materia Medica Holding" has obtained GMP certificates from Slovakia and Ukraine

In October 2012, manufacturing unit of OOO "NPF "Materia Medica Holding" located in Chelyabinsk successfully completed the audit of State Administrations of Ukraine and Slovakia.

The result of two EU GMP audits by State Administration of Ukraine on Medicinal Products (SAUMP)) and State Institute for Drug Control (SIDC)) was the issue of two GMP certificates to the company.

The event was commented by Marketing and Development Director of OOO "NPF "Materia Medica Holding" Yakov Efimovich Zilberman:

GMP certificate issue by Ukraine and Slovakia Administrations enables us to expand our activities outside of Russia.

Presently, the main strategic export market for us is Ukraine where the company subsidiary has been opened. In the middle of 2012 obligatory GMP certification was implemented in Ukraine. From January 1, 2013 these requirements shall also apply to foreign drug suppliers.

This means that the access to the market shall be limited without certificate of quality issued by State Administration of Ukraine on Medicinal Products verifying that the company complies with GMP standards. Therefore, the issue of certificate of compliance for us is a chance to reinforce our status in this country.

Verification of compliance with GMP manufacturing by State Institute for Drug Control of Slovakia, a EU country, offers new opportunities for the company drug export to European Union member states.

Reference

OOO "NPF "Materia Medica Holding" is one of the largest Russian pharmaceutical companies.

Medical representative offices of the company are found in all Russian regions, ex-CIS countries (Ukraine, Belarus, Uzbekistan, Kazakhstan, Moldova) and Middle East countries (Cambodia, Vietnam).

Short-term plans of OOO "NPF "Materia Medica Holding" include launching sales representative offices in South-Eastern Asia, Latin America, Middle East.

The products by OOO "NPF "Materia Medica Holding" have been authorized in all CIS countries. Almost 90% of all RF drugstores purchase and market the company products; supplies are made directly or via specialized Russian exporters.

OOO "NPF "Materia Medica Holding" rates third among the national pharmaceutical drug manufacturers and exporters. About 20% products are exported. The company sells about 40 million packs annually within the RF, ex-CIS countries and South-Eastern Asia.

OOO "NPF "Materia Medica Holding" has been actively promoting authorization of its products in international markets. A number of drugs have been successfully authorized and their marketing in South-Eastern countries – Vietnam and Cambodia – has been launched.

OOO "NPF "Materia Medica Holding" has registered more than 40 patents in Russia and abroad, including 5 in the USA.

The company develops and launches at least one original drug on an annual basis. The Company has been actively cooperating with the leading Russian and foreign scientific institutes and companies with purpose of performing new studies and obtaining clinical data.

In 2011 OOO "NPF "Materia Medica Holding" became the leading Russian company in terms of the number of clinical studies, number of subjects enrolled and study sites involved (according to “Synergy Research Group” report).