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Filtering on: "topics apis"

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FDA Warns Two Drugmakers in China and India for Data Integrity Violations By Michael Mezher - Published 21 March 2017

The US Food and Drug Administration (FDA) has warned two drugmakers, USV Private Limited in Daman, India and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. in Zhangqiu City, China, over data integrity and manufacturing issues uncovered during inspections last year.

Categories: News, China, India, US, FDA, APIs, Compliance, Drugs, Manufacturing

Tags: Data Integrity

FDA Warns Megafine Over Data Integrity Violations at Second Facility By Michael Mezher - Published 07 March 2017

The US Food and Drug Administration (FDA) last month warned Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma Ltd. over data integrity and manufacturing violations at its Gujarat, India facility.

Categories: News, India, US, FDA, APIs, Drugs

Tags: Data Integrity

FDA Warns Spanish API Maker for GMP Violations By Michael Mezher - Published 06 December 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Spanish active pharmaceutical ingredient (API) maker Interquim, S.A. for several good manufacturing practices (GMP) violations uncovered during an inspection of the company's Barcelona facility last May.

Categories: News, Europe, US, FDA, Active pharmaceutical ingredients, APIs, Manufacturing

Tags: Warning Letter, Good Manufacturing Practice, GMP

FDA Warns Japanese API Maker Over Data Integrity Issues By Michael Mezher - Published 15 November 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Japanese active pharmaceutical ingredient (API) maker Sekisui Medical Co., Ltd. for a series of data integrity issues at the company's Iwate, Japan site.

Categories: News, Japan, US, FDA, Active pharmaceutical ingredients, APIs, Manufacturing

Tags: Data integrity

'The Rooms Had Never Been Cleaned': Two New FDA Warning Letters for Chinese Manufacturers By Michael Mezher - Published 27 September 2016

The US Food and Drug Administration (FDA) has sent warning letters to two Chinese active pharmaceutical ingredient (API) makers over data integrity and good manufacturing practice (GMP) violations.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, APIs, Compliance, Drugs, Manufacturing

Tags: Data integrity, warning letter

FDA Warns Pan Over Data Integrity, Sanitation Issues By Michael Mezher - Published 07 September 2016

For the second time in less than a year, the US Food and Drug Administration (FDA) has issued a warning letter to Indian active pharmaceutical ingredient (API) maker Pan Drugs over data integrity and sanitation violations at one of its facilities.

Categories: News, India, US, FDA, Active pharmaceutical ingredients, APIs, Compliance, Drugs, Manufacturing

Tags: Data Integrity, Pan Drugs, Warning Letter

FDA Warns Indian API Maker Unimark for Deviations at Two Facilities By Michael Mezher - Published 24 August 2016

The US Food and Drug Administration (FDA) has issued a warning letter to active pharmaceutical ingredient (API) maker Unimark Remedies Ltd. for poor manufacturing controls and data integrity issues at two of its facilities in India.

Categories: News, India, FDA, Active pharmaceutical ingredients, APIs, Manufacturing

Tags: Unimark Remedies, Data Integrity, Lizard

FDA Warns Two Chinese Drugmakers for Data Integrity Violations By Michael Mezher - Published 30 June 2016

The US Food and Drug Administration (FDA) has issued warning letters to two Chinese drugmakers over manufacturing and data integrity issues, including backdated tests and falsified records.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, APIs, Compliance, Drugs, Manufacturing, Quality

Tags: Data integrity, Warning letter

FDA Offers New Bioequivalence Study Guidance for 31 Generic Drug Ingredients By Zachary Brennan - Published 27 January 2016

To help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval, the US Food and Drug Administration (FDA) has published draft product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) and revised recommendations for 11 APIs.

Categories: News, US, FDA, Active pharmaceutical ingredients, APIs, Clinical, Generic drugs, Due Diligence, Regulatory strategy, Research and development

Tags: bioequivalence studies, active ingredients, ANDAs, FDA draft guidance

FDA Warns Indian API Manufacturer for Data Integrity Issues, Wild Lizard By Michael Mezher - Published 13 October 2015

The US Food and Drug Administration (FDA) on Tuesday again revealed data integrity deviations in India, this time from an inspection of Unimark Remedies' facility in Bavla, India, which produces active pharmaceutical ingredients (APIs) for at least two antibiotics – cephalosporin and carbapenem.

Categories: News, India, US, FDA, Active pharmaceutical ingredients, APIs, Drugs

Tags: Lizard, Data Integrity

Bringing Structure to Substance Information By Niels Henriksen - Published 28 August 2015

This article discusses compliance challenges  pharmaceutical companies face with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standard for structured  substance information.

Categories: Articles, Features, ISO, Active pharmaceutical ingredients, APIs, Postmarket surveillance

Tags: pharmaceuticals, pharmacovigilance, International Organization for Standardization, ISO, Identification of Medicinal Products, IDMP

China FDA 'Flying Inspections' for Drugs: How They Work By Feng Yu - Published 08 January 2015

The China Food and Drug Administration conducts special drug manufacturing inspections without advanced notice. These so-called “flying inspections” are in addition to regular GMP inspections. The article provides a summation of the key elements of CFDA’s proposed flying drug regulation, including its objective, scope, inspectors’ responsibilities and process.

Categories: Features, China, CFDA, Active pharmaceutical ingredients, APIs, Compliance, Drugs, Manufacturing

India’s CDSCO Reduces API Stability Testing Data Requirement By Louise Zornoza, RegLink News - Published 29 October 2014

India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on 22 October 2014 cutting the long term stability testing data requirement for active pharmaceutical ingredient (API) exports to the EU from 12 months to 6 months based on results from three batches. 

Categories: News, India, CDSCO, Active pharmaceutical ingredients, APIs, Drugs

Tags: Stability Testing, Accelerated Stability Data

China's Regulatory Procedure and Inspection System By Feng Yu and Siegfried Schmitt, PhD - Published 24 October 2014

Current information on the China Food and Drug Administration regulatory authorities and its inspection systems, including the role of Provincial and City FDAs.

Categories: Features, China, CFDA, Active pharmaceutical ingredients, APIs, Prescription drugs

Tags: CFDA, regulatory authorities, Provincial FDA, City FDA, inspection processes