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Two Foreign API Manufacturers Issued Warning Letters

In June, Apotex and Tianjin Zhongan Pharmaceutical received warning letters addressing API manufacturing issues. Apotex was cited in its letter for data integrity issues at its facility in Bangalore, India, based on inspection findings in late January. The inspection findings resulted in an import alert being placed on products from the facility in April (IPQ […]

EDQM Signs Confidentiality Agreement with Taiwan FDA

In late May, EDQM signed a confidentiality agreement with the Taiwan FDA. The confidentiality agreement concerns the “certification of suitability to the monographs of the European Pharmacopoeia,” and includes communications about the quality assessment of APIs and excipients used in manufacturing as well as about GMP inspections of manufacturing sites.

China’s FDA Voices Interest in Developing an Excipient DMF System at Meeting with IPEC China; India Among Countries Reviewing Excipient Regulatory Upgrades

China is among countries giving consideration to establishing a drug master file (DMF) system for excipients, as regulators world-wide seek to rationalize and improve their approaches to excipient oversight....

India Looks to Double Drug Inspectors

In mid-May, the Indian government announced plans to double the number of drug inspectors and install quality testing facilities at ports within the next three years as part of a $500 mil. plan to increase India’s drug regulatory capacity. The increase in its oversight program follows in the wake of recent compliance actions taken by […]

Warning Letter to Sun Cites Integrity Issues at Indian Plant

FDA issued a warning letter to Sun Pharmaceuticals in early May in the wake of a November 2013 inspection that found data integrity problems at the firm’s Karkhadi, India API facility, which resulted in it being placed on FDA’s import alert list in March. Integrity concerns cited at the facility included: lack of raw data, […]

Ranbaxy Facing Criminal Charges in India

In early May, Ranbaxy faced criminal charges brought against it by the Indian state of Kerala due to subpotent amoxycillin and the labeling of an osteoporosis drug as a dietary supplement.

India to Partner with Private Firms in Re-Branding Indian Pharma

In the Economic Times of India in early May, Commerce Secretary Rajeev Kher laid out a plan for a “Brand India Pharma” campaign, designed to reinvigorate the international view of pharmaceuticals made in India.

Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention

An analysis of FDA drug GMP warning letters issued since the beginning of 2012 highlights the agency’s increasing focus on enforcement outside the US – and on laboratory practices at foreign facilities, in particular....

FDA Data Integrity Findings Continue at Indian Firms, Highlighting Challenges in Changing a Facility’s Quality Culture

FDA investigators are continuing to uncover serious data integrity issues at facilities in India, including repeat citations – highlighting the challenges regulators face in getting companies to make changes in their quality culture....

Component Testing Gains Prominence in Drug Product GMP Warning Letters as FDA Focus Intensifies on OTC Topicals and Upstream Supply Chain

Inadequate testing of incoming components is a leading problem area being cited by FDA on finished drug product GMP warning letters and is particularly prevalent in the expanding number of those addressing compliance at topical manufacturers worldwide....
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