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Filtering on: "topics active pharmaceutical ingredients"

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New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India By Zachary Brennan - Published 14 March 2017

The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March.

Categories: News, Asia, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Government affairs

Tags: warning letters, API manufacturers, water and pharmaceuticals

FDA Warns China API Manufacturer for Data Integrity Violations By Michael Mezher - Published 01 March 2017

The US Food and Drug Administration (FDA) in late February warned Fosun Pharmaceutical subsidiary, the formerly Chinese state-owned Chongqing Pharmaceutical Research Institute (CPRI), over data integrity issues.

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

Tags: Data Integrity

CDRH and CDER Send Warning Letters to Six Asian Companies By Zachary Brennan - Published 14 February 2017

The flurry of US Food and Drug Administration (FDA) warning letters continued on Tuesday with the release of six new warning letters for pharmaceutical and medical device companies in China, India, Taiwan and Japan.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Drugs, Government affairs, Manufacturing, Medical Devices, Quality

Tags: warning letters, China drug manufacturing, India drug manufacturing

When Can Drugmakers Cite Quality Standards From Foreign Compendia? FDA Explains By Zachary Brennan - Published 27 January 2017

An updated Manual of Policies and Procedures (MAPP) for the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) lays out when drug sponsors and applicants can propose specifications for excipients, drug substances and drug products in their applications based on quality standards in the British Pharmacopoeia (BP), the European Pharmacopoeia (EP) or the Japanese Pharmacopoeia (JP).

Categories: News, US, FDA, Active pharmaceutical ingredients, Drugs, Government affairs

Tags: quality standards pharmaceuticals

FDA Warns One Japanese, One Chinese Drugmaker By Michael Mezher - Published 18 January 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month.

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

Tags: Warning Letter, Data Integrity, Import Alert

Drug Compounding With Bulk Substances: FDA Offers Interim Policies By Zachary Brennan - Published 16 January 2017

The US Food and Drug Administration (FDA) late Friday issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency does not intend to take action against certain outsourcing facilities and compounded drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Quality

Tags: drug compounding, compounded drugs, 503A, 503B, FDA interim policy

Submitting Manufacturing Establishment Info Electronically: FDA Offers Draft Guidance By Zachary Brennan - Published 03 January 2017

Pharmaceutical manufacturers take note: The days of non-electronic submissions of establishment information are coming to an end, possibly as soon as 2019.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Compliance, Drugs, Manufacturing

Tags: pharmaceutical manufacturing, draft guidance, manufacturing information

FDA Warns Wockhardt for Destroying CGMP Documents, Other Violations By Zachary Brennan - Published 03 January 2017

The beleaguered Indian drug manufacturer Wockhardt is in trouble again with the US Food and Drug Administration (FDA), this time for destroying current good manufacturing practice (CGMP) documents, among a list of other major violations.

Categories: News, Asia, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs, Due Diligence, Manufacturing

Tags: warning letter, Wockhardt, CGMP

FDA Offers New Bioequivalence Recommendations for 31 Active Ingredients, 13 Revisions By Zachary Brennan - Published 22 December 2016

The US Food and Drug Administration (FDA) on Thursday announced the latest batch of new draft guidance for the generic drug industry on 31 product-specific bioequivalence (BE) recommendations and 13 revisions to prior recommendations.

Categories: News, US, FDA, Active pharmaceutical ingredients

Tags: BE studies, generic drug guidance from FDA, active ingredients

Japan Joins International API Manufacturing Inspection Program By Zachary Brennan - Published 15 December 2016

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced Thursday that it will join with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators to improve the efficiency and effectiveness of good manufacturing practice (GMP) inspections for sites producing active pharmaceutical ingredients (APIs).

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Active pharmaceutical ingredients, Manufacturing

Tags: ICH Q7, API manufacturing inspections

FDA Proposes New Rule on Bulk Substances Used to Compound Drugs By Zachary Brennan - Published 15 December 2016

The US Food and Drug Administration (FDA) on Thursday issued a proposed rule that looks to add six bulk drug substances to a list of such substances that can be used in compounding and to remove four other bulk drug substances that FDA evaluated and should not be included in the list.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Manufacturing, Quality

Tags: drug compounding, 503A bulks list, bulk drug substances, APIs

Companies Producing Drugs Only for INDs Exempt From FDA Registration By Zachary Brennan - Published 12 December 2016

The US Food and Drug Administration (FDA) on Monday published a correction to a recent final rule on registering foreign and domestic manufacturing establishments, clarifying that a company producing solely products for investigational new drug (IND) applications is exempt from registration.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: FDA registration for manufacturing, IND manufacturing, drug establishment manufacturing

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 Chinese Heparin Manufacturer, Reigniting Questions of Contamination By Zachary Brennan - Published 29 November 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to a China-based manufacturer of heparin—the same manufacturer warned by French regulators last March.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: heparin, warning letter, heparin manufacturers in China

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

FDA Warns Chinese Drug Manufacturer for Limiting Inspection, Systemic Data Manipulation By Zachary Brennan - Published 01 November 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Beijing Taiyang Pharmaceutical Industry Co. on 19 October after the company limited FDA’s ability to conduct an inspection and manipulated manufacturing data.

Categories: News, US, FDA, Active pharmaceutical ingredients, Drugs, Government affairs, Manufacturing, Quality

Tags: FDA warning letter, China data manipulation, API manufacturer warning

Asia Regulatory Roundup: India Looks to Meet WHO Standards for GMPs (11 October 2016) By Nick Paul Taylor - Published 11 October 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, WHO, Active pharmaceutical ingredients, Clinical, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, DCGI, India, GMPs, clinical trial applications in India

French Regulators Raise Serious Concerns With Indian API Manufacturer By Zachary Brennan - Published 10 October 2016

France’s National Agency for Medicines and Health Products Safety (ANSM) on Monday released a new statement of serious good manufacturing practice (GMP) non-compliance for India-based active pharmaceutical ingredient (API) manufacturer Nandu Chemicals Industries.

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Compliance, Crisis management, Government affairs, Manufacturing

Tags: ANSM, Indian API manufacturer, Nandu Chemicals, statement of non-compliance

WHO Seeks API Manufacturers for Prequalification Program By Zachary Brennan - Published 10 October 2016

The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and treatment of HIV/AIDS, hepatitis B and C, tuberculosis, malaria, neglected tropical diseases, influenza, diarrhea and support reproductive health.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, ICH, WHO, Active pharmaceutical ingredients, Crisis management, Due Diligence, Government affairs, Manufacturing

Tags: WHO prequalification program, API manufacturing, ICH, regulatory authorities and WHO

FDA Warns Japanese Company for Impeding Inspection By Michael Mezher - Published 06 October 2016

The US Food and Drug Administration (FDA) has warned Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA investigator from conducting an inspection of the company's facility in Takasago City, Japan, last December.

Categories: News, Asia, US, FDA, MHLW, PMDA, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs

Tags: warning letters, Nippon Fine Chemical, FDA inspections

WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable By Zachary Brennan - Published 30 September 2016

The World Health Organization (WHO), industry groups and other partners on Friday announced a new financing arrangement that will add $20 million annually in new industry fees to ensure the financial sustainability and quality of WHO’s prequalification program.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, WHO, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: WHO, prequalification of vaccines, prequalification of medicines, WHO funds

'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 Finalizes Guidance on Generic Drug Facility Self-Identification By Zachary Brennan - Published 22 September 2016

The US Food and Drug Administration (FDA) on Thursday finalized guidance on information regarding what companies need to self-identify as a producer of generic drugs and what information they must provide to FDA.

Categories: News, US, FDA, Active pharmaceutical ingredients, Generic drugs, Government affairs, Manufacturing

Tags: GDUFA, generic facility self-identification, FDA guidance

Regulatory Recon: FDA’s Califf Calls for Sarepta Trial Retraction; Alzheimer’s Drug Fails in Phase III Study (22 September 2016) By Zachary Brennan - Published 22 September 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Canada, Europe, US, EC, EMA, FDA, MHRA, NICE, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

FDA to Revise Draft Guidance on Quality Metrics Data By Zachary Brennan - Published 12 September 2016

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday offered a couple of revisions to its list of guidance documents for 2016. Most notably, a revision to the agency’s draft guidance on quality metrics is expected later this year.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Government affairs, Manufacturing, Quality

Tags: quality metrics, pharmaceutical quality, FDA quality metrics guidance, CDER draft guidance