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EU Member States suspend generics approvals due to problems at CRO

The European Medicines Agency (EMA) announced on 5 December 2014 that some Member States have decided to suspend the marketing authorizations of medicines that have been authorized on the basis of studies conducted at India-based contract research organization (CRO) GVK Biosciences (GVK Bio) Hyderabad site.

Investigation into huge price increases for generics in the US

Two US Congressmen have sent letters to 14 drug manufacturers, including several major Indian firms, requesting information about the escalating prices they have been charging for generics.

Canada partially lifts import ban on Indian manufacturing sites

In an attempt to avert drug shortages, Canada’s drug regulatory agency, Health Canada, has partially lifted an import ban on products from three Indian manufacturing facilities that were banned from importing generics into the country due to quality violations.

FDA names and shames firms for failing to pay generics fees

No less than 28 generics makers are currently on the US Food and Drug Administration’s (FDA) GDUFA (Generic Drug User Fee Amendments) Facility Arrears List for failing to pay generics fees for 2013 and 2014.

Canada bans imports from three API facilities in India

Just days after Canada’s regulatory agency was reported to be in talks with the US Food and Drug Administration (FDA) about Canadian generics maker Apotex, Health Canada has announced that it is to ban imports from two of Apotex’s facilities and from one site belonging to IPCA Laboratories in India.

Thirty years of generics in the US

On 24 September 2014, the US Food and Drug Administration (FDA) celebrated 30 years of generics in the US.

Generics taskforce for Australia

Australia’s Generic Medicines Industry Association (GMiA), which represents companies that manufacture, supply and export generics, has called on the country’s Minister for Industry to convene a Medicine Manufacturing Taskforce.

Generics applications under review by EMA – August 2014

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein, and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

Generic hepatitis drug to be made available to 80 countries

Originator pharma company Gilead Sciences (Gilead) is reportedly close to reaching a deal with generics makers to bring low cost versions of its hepatitis C drug Sovaldi (sofosbuvir) to about 80 developing countries including India, Indonesia, and Pakistan, as well as Egypt, Mongolia, South Africa, and Vietnam.

Lawyers look at new price hike for old drug

Two generic drug companies are being investigated by the Connecticut Attorney General’s office following reports of alarming price hikes for the heart medicine digoxin. Possible price fixing by Impax Laboratories (Impax) and Lannet, which manufacture digoxin, is being investigated.

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