Tag: GMP

FEFU to Launch Russia’s First University-Based GMP Site for Biologics

Far Eastern Federal University (FEFU) has announced plans to establish a comprehensive infrastructure for the development and commercialization of biotech products.

Russia Updates Pharma Licensing: New Timelines and Remote Inspections

The Russian Government has approved a new resolution updating the procedure for licensing pharmaceutical manufacturing. The document, prepared by...

GMP-inspections of veterinary manufacturers in the second half of 2021

The review provides information related to the inspection of manufacturers of medicinal products for veterinary use for compliance with the requirements of the Good Manufacturing Practice (GMP).

Petrovax presents its products in Europe

Russian pharmaceutical company Petrovax is expanding its export portfolio and considering new markets for its pharmaceuticals and vaccines. At...

Areplivir developed by Promomed for the treatment of coronavirus infection received marketing authorization in Uzbekistan

Areplivir, included in the guidelines of the Ministry of Health of Russia for the treatment of COVID-19, received marketing...

WHO revises guidance on GMPs for investigational products and R&D facilities

WHO said the objective of the update is to align the guidance with “current expectations and trends in good manufacturing practices”.

GMP-Inspections of foreign veterinary manufacturers in the first half of 2021

This review contains the latest information related to inspection of manufacturers of veterinary medicinal products manufactured outside the Russian...

EAEU GMP Certificate issued to Pharmasyntez

The Pharmasyntez Group of Companies also was one of the first in Russia to be granted a Marketing Authorization under the EAEU rules.

NANOLEK will invest 5 billion rubles in the full production cycle

Nanolek, a biopharmaceutical company, announces a plan to invest 5 billion rubles over 3 years in its full-cycle vaccine production facility in the Kirov region and an R&D Center for Biotech Medicines in Moscow.

Yposkesi launches construction of its second commercial bioproduction site

Yposkesi, a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapies, announces the launch of...

East-Pharm to Choose Kaluga SEZ

East-Pharm is a modern Russian high-tech pharmaceutical company specializing in the production of infusion solutions in accordance with GMP.

Cambrex Introduces New Kilogram-Scale GMP Manufacturing Capabilities at Tallinn, Estonia Facility

The site in Tallinn provides custom organic synthesis and contract research, analytical and development services, working on process development and scale-up synthesis to kilogram quantities.