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FDA creates new division to speed up generic approval times

As the FDA’s Office of Generic Drugs (OGD) struggles to keep up with its growing backlog of abbreviated new drug approvals (ANDAs), the office is creating a new chemistry division that it hopes will allow speedier generic drug approvals.

Generic substitution of cyclosporin sometimes undesired

The bio-equivalence criteria of the Dutch Medicines Evaluation Board (CBG-MEB) offer insufficient guarantee for a safe substitution of generic medicines in transplantation medicine, argue Internist-Nephrologist/Clinical Pharmacologist Teun van Gelder of the Erasmus MC and Professor of Surgery Robert Porte of the University of Groningen –both members of the board of the Nederlandse Transplantatie Vereniging (NTV) – in Pharmaceutisch Weekblad of 29 January 2010.

India claims to be world leader in generics exports

The Indian government has said that India ranks top in the world in exporting generic medicines, with a worth of 50,000 billion rupees a year. The country is now exporting to more than 200 nations worldwide, and exports totalled around US$8 billion in 2008-9, the majority going to the US and Europe, according to ‘Union Minister of State for Chemicals and Fertilisers Srikanta Jena’. ‘The industry’s achievements could create more than 500,000 high-value jobs in India and provide the nation with low-cost treatments for life-threatening conditions such as malaria and tuberculosis’, he added.

EGA wants better Centralised Procedure and Decentralised Procedure for generics authorisation

The European Generic medicines Association (EGA) presented ‘Vision 2015’, which aims to create a globally competitive generic industry, increase patient access to affordable quality medicines and ensure sustainable health care in Europe, e.g. by improving the EU's centralised procedure (CP) and decentralised procedure (DCP) for authorising medicines.

Should Indian generic firms partner with Big Pharma?

After years of warding off generics, large pharmaceutical companies are embracing generic drug manufacturers and vying for a share of the off-patent drugs business. Indian generic companies, once considered business pariahs, are the focus of plenty of action, Anju Ghangurde reports in Scrip News of 9 December 2009.

Big Pharma’s generics entry and generic drug prices

After years of warding off generics, large pharmaceutical companies are embracing generic drug manufacturers and vying for a share of the off-patent drugs business. Indian generic companies, once considered business pariahs, are the focus of plenty of action, Anju Ghangurde reports in Scrip News of 9 December 2009.

Big Pharma’s strategic detour into generics

After years of warding off generics, large pharmaceutical companies are embracing generic drug manufacturers and vying for a share of the off-patent drugs business. Indian generic companies, once considered business pariahs, are the focus of plenty of action, Anju Ghangurde reports in Scrip News of 9 December 2009.

Big Pharma finally warms to generic pariahs

After years of warding off generics, large pharmaceutical companies are embracing generic drug manufacturers and vying for a share of the off-patent drugs business. Indian generic companies, once considered business pariahs, are the focus of plenty of action, Anju Ghangurde reports in Scrip News of 9 December 2009.

Very few API plants in China allowed to supply the EU

Member of the European Parliament (MEP) Amalia Sartori has questioned the European Commission (EC)’s estimate that 20,000 active pharmaceutical ingredient (API) producers supply the EU, which was used to justify not having mandatory inspections.

Confusion about number of European API plants in China

A member of the European Parliament (MEP) has questioned the European Commission (EC)’s estimate that 20,000 active pharmaceutical ingredient (API) producers supply the European Union (EU), which was used to justify not having mandatory inspections, and the CEO of Hovione added that the numbers have been “dramatically misunderstood”.

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