Tag: GMP certificate

FDA Classified 3P Biopharmaceuticals Facilities as Acceptable for Manufacture of Target Molecule

3P Biopharmaceuticals, a contract development and manufacturing organization (CDMO) specialized in process development and GMP manufacturing of biologics, has received FDA approval after completing th...

Rentschler Fill Solutions Received Unlimited GMP Certification

Rentschler Fill Solutions GmbH has received notification from the Austrian Agency for Health and Food Safety (Agentur für Gesundheit und Ernährungssicherheit, AGES) that the pharmaceutical manufacturi...

First Biologic Company in China Approved by FDA and EMA

WuXi Biologics, a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, announced that it has received ...

EMA’s Clearance about GMP Certificate Validation after Brexit

The European Medicines Agency (EMA) has updated the agency's Brexit-related guidance documents. These documents are supporting pharmaceutical companies in preparing for the United Kingdom's (UK) withd...

Swissmedic Started to Enter GMP Compliance Information into EudraGMDP

The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance as well as on manufacturing authorisations related to Sw...

Mutual Recognition of GMP Certificates in EAEU

In Sochi, within the «Healthy Life. On the Way to Target 80+» Forum, a session under the topic «The system of universal health coverage as a key to achieving the national target» was held. How much...

157 Russian License Holders Received GMP-Certificates

In anticipation of the Russian Investment Forum, today, in Sochi, the Healthy Life Forum has been started with its key topic being the system of universal health coverage aimed at achievement of the 7...

Indian Company WHO-GMP Certified

A Kala Amb, India based pharmaceutical manufacturing unit Vidhyasha Pharmaceuticals a WHO-GMP and an ISO9001:2008 and 22000:2005 certified organization having state-of-the-art facility for the manufac...

Idifarma announced renewal of its EU-GMP certificate

Idifarma, a Spanish contract development and manufacturing organisation (CDMO), announced the installation of GEA Niro Mobile Minor equipment in a new dedicated area in its EU GMP plant.

The Iranian Drug Control Authority issued a GMP certificate to SPbRIVS

St. Petersburg Research Institute of Vaccines and Serums of the FMBA of Russia successfully passed an audit with the specialists of the Food and Drug Administration of the Islamic Republic of Iran.

Valenta Pharm received GMP conclusion from Russian Ministry of Industry and Trade

Valenta Pharm has received the conclusion of the Russian Ministry of Industry and Trade on compliance of its new Valenta Research & Production Facility with the standards and requirements of Good Manufacturing Practice.

EEC changed rules for registration of vaccines and use of GMP certificates

The Council of the Eurasian Economic Commission (EEC) has amended the rules for registration and expert examination of medicinal products for human use in the Eurasian Economic Union.

Quality system and manufacturing conditions of SANTO meet international standards

SANTO, a company, received three important certificates for compliance with the Good Manufacturing Practice (GMP) for its production sites engaged in manufacturing of solutions for injection, infusion, and solid oral medicines.

Fitoleum from Kazakhstan received its GMP certificate

An official ceremony marking the issuance of GMP certificate to Fitoletum, a pharmaceutical company from Kazakhstan, was held in the Pharmacy Committee of Kazakhstan’s Ministry of Health.

Iranian biosimilar company CinnaGen obtained GMP certification from EMA

The Iranian biosimilar company CinnaGen has achieved a notable first for the Middle East and North Africa (MENA) region.

Only 12 out of 94 pharma manufacturers in Uzbekistan have GMP certificates

The President of the Republic of Uzbekistan Shavkat Mirziyoyev chaired a meeting to review the results of ongoing activities aimed at developing the pharmaceutical industry