Search Results for Apotex

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UK's MHRA: Apotex Site Does Not Comply With GMP Requirements By Zachary Brennan - Published 18 December 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) found Apotex Research Private Limited's Bangalore, India-based manufacturing site to be noncompliant.

Categories: News, Asia, Europe, MHRA, Compliance, Crisis management, Due Diligence, Manufacturing

Tags: GMP requirements, Apotex, statement of noncompliance

Biosimilar ‘Patent Dance’: Federal Circuit Rules 180-Day Notice is Mandatory By Zachary Brennan - Published 05 July 2016

The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Research and development

Tags: biosimilar patent dance, Apotex, Amgen, Federal Circuit

Sandoz Petitions Supreme Court to Rule on Biosimilars By Zachary Brennan - Published 17 February 2016

Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before bringing their product to market.

Categories: News, US, FDA, Biologics and biotechnology, Business Skills, Compliance, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Supreme Court, SCOTUS, biosimilar lawsuit, biosimilar litigation, Sandoz, Amgen, Apotex, Zarxio

GPhA’s Biosimilars Council: BPCIA Provides 12 Years Exclusivity, Not 12.5 By Zachary Brennan - Published 07 January 2016

The Generic Pharmaceutical Association’s Biosimilars Council is taking issue with a recent court decision that could effectively delay the launch of biosimilars in the US by an additional six months, according to an amicus brief.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, GPhA, Apotex, Amgen

Health Canada Overruled on Apotex Import Ban By Zachary Brennan - Published 04 November 2015

A Canadian federal court has ruled against Health Canada’s decision to restrict pharmaceutical imports from two Apotex facilities in India, though the US FDA still bans products from these facilities.

Categories: News, India, Canada, US, FDA, Health Canada, Drugs, Manufacturing, Postmarket surveillance, Product withdrawl and retirement, Quality, Regulatory intelligence, Regulatory strategy

Tags: Apotex, Health Canada, data integrity, India drug manufacturing, Rona Ambrose

Rare Multi-Facility Warning Letter Slams Manufacturer, Says Concerns Extend to All Plants By Alexander Gaffney, RF News Editor - Published 20 March 2013

Categories: Canada, FDA

Tags: Apotex, warning letter, Latest News, cGMP, process validation, CAPA

FDA Approves Eleven Generic Versions of Plavix as Drug Goes Off-patent By Alexander Gaffney - Published 18 May 2012

Categories: FDA

Tags: BMS, Patent Cliff, Plavix, Apotex, Sanofi, Latest News, pharmaceutical, approval, drug

Generic Boniva Approved, Marking Next Big Patent Expiry By Alexander Gaffney - Published 20 March 2012

Categories: FDA

Tags: Expiration, Ibandronate, Boniva, MedGuide, Apotex, Orchid Healthcare, Roche, Mylan, Generic, Latest News, Patent