Pharmafile Logo
Pharmafocus logo
Advanced Search

GMP

Showing 15 posts of 51 posts found.

Boehringer image

Boehringer says it is rolling out ‘fully disposable’ biomanufacturing

September 18, 2012
Manufacturing and Production Boehringer, CMO, GMP, SUSs

Boehringer Ingelheim says it has developed a production platform for biopharmaceuticals that makes full use disposable technologies both upstream and …

News

Brazil delays excipient GMP deadline

September 6, 2012
Manufacturing and Production ANVISA, Brazil, GMP

Brazil’s national medicines regulatory agency ANVISA has delayed proposed new rules on good manufacturing practice (GMP) for pharmaceutical excipients after …

News

GMP certification bodes well for Alexza’s lead product

August 28, 2012
Manufacturing and Production Alexza, FDA, GMP, schizophrenia

US drugmaker Alexza Pharmaceuticals’ manufacturing facility for lead product Adasuve has been given a green light from the Spanish medicine …

News
Ercros image

Spanish API supplier Ercros warned by FDA

July 17, 2012
Manufacturing and Production Ercros, FDA, GMP

Spanish chemical supplier Ercros SA has been sent a warning letter from the FDA after an inspection picked up a …

News

China sets out quality rules for pharma excipients

July 3, 2012
Manufacturing and Production China, GMP, IPEC, manufacturing

China’s State Food & Drug Administration has published a draft regulation laying out a number of new measures for boosting …

News

Novartis will restart production at Lincoln plant in May

May 1, 2012
Manufacturing and Production FDA, GMP, Lincoln, Nebraska, Novartis, manufacturing

Novartis chief executive Joe Jimenez has said that production at the firm’s troubled consumer health plant in Lincoln, Nebraska, will …

News

Excipient certification scheme launches

February 13, 2012
Manufacturing and Production EXCiPACT, GDP, GMP, manufacturing

A consortium of industry associations has launched a certification scheme for pharmaceutical excipients to make it easier for drugmakers to …

News

GMP issues affect Mircera, Xenical production at Roche plant

January 31, 2012
Manufacturing and Production GMP, Mircera, Roche, Tamiflu, Xenical

Supply of two Roche products has been disrupted after an active pharmaceutical ingredient (API) production facility in the US was …

News

European falsified meds directive: implications for manufacturers

June 7, 2011
Manufacturing and Production APIs, GDP, GMP, excipients, pharma manufacturing

The Council of the European Union gave its backing to the new Directive on Falsified Medicines on May 27, setting …

News

FDA issues guidance on preventing antibiotic cross-contamination

April 19, 2011
Manufacturing and Production FDA, GMP, pharma manufacturing

The FDA has published a new guidance document to help drugmakers prevent cross-contamination of pharmaceuticals with non-penicillin beta-lactam antibiotics. The …

News

China’s new GMP rules will lead to industry consolidation

April 4, 2011
Manufacturing and Production China, GMP

China’s new rules on Good Manufacturing Practice is likely to drive consolidation among the country’s 5,000-plus pharmaceutical companies, according to …

News

FDA issues guidance on glass contamination

March 29, 2011
Manufacturing and Production FDA, GMP, glass contamination

The FDA has issued an advisory to pharmaceutical manufacturers on the topic of contamination with thin glass fragments – or …

News

Helsinn expands high-potency plant with cytotoxics suite

March 8, 2011
Manufacturing and Production APIs, CMOs, GMP, Helsinn, Helsinn Advanced Synthesis, Swiss pharma contract manufacturing, contract manufacturing, high-potency APIs

Helsinn is on track to complete construction of a new manufacturing plant for cytotoxic active pharmaceutical ingredients in Biasca, Switzerland, …

News

BMS and Sanofi recall 64 million Avalide tablets

January 18, 2011
Manufacturing and Production Avalide, Avapro, Bristol-Myers Squibb, GMP, Good Manufacturing Practice, Sanofi-Aventis, hypertension, irbesartan

Bristol-Myers Squibb and Sanofi-Aventis have started another massive recall of their antihypertensive product Avalide because a manufacturing defect could affect …

News

Rising Angel plans manufacturing expansion

November 16, 2010
Manufacturing and Production Andrew Carver, Angel Biotechnology, GMP, Good Manufacturing Practice, Pentlands Science Park, Susan McKee, contract manufacturing

Scottish contract manufacturing company Angel Biotechnology plans to increase its capacity by taking over a mothballed production facility after signing …

News
The Gateway to Local Adoption Series

Latest content

Just – Evotec given Gates Foundation grant to increase global biotherapeutics access

January 8, 2026

Johnson & Johnson submits robotic surgical system for De Novo classification

January 8, 2026

EA Pharma announces phase 3 trial for new schizophrenia treatment in Japan

January 7, 2026

Eleva appoints Erich Rajkovic as Chief Business Officer

January 7, 2026

MedPharm announces US FDA inspection of North Carolina manufacturing facility

January 6, 2026