Wockhardt becomes India's first to get regulatory nod for novel antibiotics

The Mumbai-based drugmaker prepares to launch EMROK in the domestic market

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World’s first VR educational platform for sterile manufacturing launches

UK regulator MHRA has given a nod to new online platform Virtuosi

FDA approves ANI's potassium citrate ANDA

Potassium citrate extended-release tablets have been indicated for the management of calcium-related diseases

FDA conducts NDMA testing on stomach acid medication

Multiple testing labs have now expressed concern over NDMA levels in ranitidine and nizatidine, urging the government ...

Unlocking traceability and efficiency within the supply chain

ProGlove's Axel Schmidt explains how accurate and efficient barcode scanning can be achieved to deliver traceability ...

Boehringer is first to take advantage of new Chinese regulations

Tislelizumab is the first biopharmaceutical manufactured by a multinational CDMO in China and the first commissioned ...

Vertex reaches agreement with Republic of Ireland for Trikafta

Game-changing cystic fibrosis drug has been fast-tracked and approved by the US FDA, and is under review by the EMA

IntelGenx: Oral films are drug development’s patent trick

Exploiting improvements in bioavailability, the Canadian company has developed unique oral film technology to help ...

Event review: CPhI & P-MEC India 2019

One key trend to emerge at the event was the continued goal of aligning India to Western regulatory standards to help ...

Glenmark receives Czech GMP certificate for Indian facility

Glenmark Pharmaceuticals' Baddi manufacturing unit in the India has fulfilled GMP recommendation in line with the WHO

Expediting clinical trials with a global transportation footprint and clinical packaging

Clinical trials are increasingly global and include both traditional structures and newer site-free models with direct- ...

Super early bird tickets now on sale for Manufacturing Chemist Live 2020

Manufacturing Chemist Live will provide guidelines and regulations for delegates seeking solutions to optimise ...

EU MDR compliance: Preparing the ground for a new regulatory environment

In September 2019, KPMG issued a report exploring the race to EU MDR compliance amongst medical device manufacturers. ...

Colorcon coalition puts edible barcodes on pills

A new innovation puts barcodes on pills rather than just packaging to guard against counterfeiting and ensure patients ...

Opinion: The CBD industry's "Wild West" needs FDA to be its sheriff

Neil Butterfield of Mineralife Nutraceuticals on why a set of stringent quality and purity policies are needed in the ...