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Lupin Warned by FDA for Deficiencies at Two Facilities By Michael Mezher - Published 15 November 2017

The US Food and Drug Administration (FDA) earlier this month warned Indian drugmaker Lupin Limited for good manufacturing practice (GMP) deficiencies at its facilities in Goa and Indore, India.

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

Tags: Warning Letter, GMP, Lupin, Goa, Indore

How Price Caps in India are Forcing US Device Companies to Sell Stents and Implants at a Loss By Zachary Brennan - Published 18 October 2017

Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales.

Categories: News, India, US, MHLW, Government affairs, In vitro diagnostics, Medical Devices, Reimbursement

Tags: stents, knee implants, India price ceilings, medical devices in india

Asia Regulatory Roundup: TGA Shares Guidance, Tool to Help Companies Navigate GMP Clearance Process (26 September 2017) By Nick Paul Taylor - Published 26 September 2017

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

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Compliance, Drugs, Manufacturing, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup, Pakistan

FDA Warns Indian Contract Manufacturer Hetero Labs By Zachary Brennan - Published 29 August 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to India-based contract manufacturer Hetero Labs’ manufacturing site on the outskirts of Hyderabad for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

Categories: News, India, FDA, Drugs, Due Diligence, Manufacturing

Tags: Hetero Labs, FDA warning letters

Asia Regulatory Roundup: India Seeks Feedback on Medical Device Safety and Performance Principles (25 July 2017) By Nick Paul Taylor - Published 25 July 2017

India has released draft guidance on the safety and performance of medical devices. The text gives companies flexibility in how they meet the design and manufacturing requirements officials see as essential to the safe, effective functioning of medical devices.

Categories: News, India, Oceania, CDSCO, TGA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

Asia Regulatory Roundup: Pfizer, Sanofi Raise Concerns on TGA Complementary Medicine Proposal (18 July 2017) By Nick Paul Taylor - Published 18 July 2017

Pfizer and Sanofi have told the Therapeutic Goods Administration (TGA) its planned changes to the rules governing complementary medicines will increase regulatory burdens. The two big pharma companies were among the organizations to raise concerns proposed changes to TGA assessment pathways and other reforms will increase burdens while decreasing flexibility.

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

US FDA Sees Major Spike in BA/BE Studies in India By Zachary Brennan - Published 19 June 2017

In 2002, the US Food and Drug Administration (FDA) did not conduct any bioavailability (BA) or bioequivalence (BE) study inspections in India for generic drug applications. A little more than a decade later, and nearly half of all FDA's BA/BE study inspections are conducted on the subcontinent.

Categories: News, India, US, CDSCO, FDA, Clinical, Crisis management, Generic drugs, Government affairs

Tags: BA and BE studies, bioequivalence, generic drugs from India

Asia Regulatory Roundup: CFDA Ordered More Inspections of Foreign Manufacturers in 2016, But Visited Fewer Sites (6 June 2017) By Nick Paul Taylor - Published 06 June 2017

The China Food and Drug Administration (CFDA) has released a breakdown of the good manufacturing practice (GMP) inspections it performed last year. The report shows another year of growth in the number of inspections of overseas manufacturers ordered by CFDA, yet the agency only performed a fraction of these planned visits.

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance

Tags: Regulatory Roundup, Asia Regulatory Roundup

WHO: Prequalified Drugs Made at Mylan's Nashik Site do not Raise Quality Concerns By Michael Mezher - Published 02 June 2017

The World Health Organization Prequalification Team (WHO-PQT) said this week that it is no longer concerned about the quality of prequalified products made at Mylan Pharmaceuticals' Nashik, India site after the US Food and Drug Administration (FDA) warned the site over quality system issues in April.

Categories: News, India, FDA, WHO, Drugs

Tags: WHO Prequalification, Mylan, Nashik

FDA Warns Indian Firm for Impeding Inspection By Michael Mezher - Published 09 May 2017

The US Food and Drug Administration (FDA) in April warned Indian pharmaceutical manufacturing company Vikshara Trading & Investments Ltd for attempting to avoid an inspection by pretending its employees were on strike and for poor conditions inside its facility.

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

Tags: Inspection, Warning Letter

New FDA Warning Letter, Form 483 for Two Indian Companies By Michael Mezher - Published 02 May 2017

The US Food and Drug Administration (FDA) in April warned Indian active pharmaceutical ingredient (API) maker Sal Pharma and handed an inspection report with six observations to major generic drugmaker Aurobindo Pharma.

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

Tags: Warning Letter, Form 483

FDA Issues Form 483 for Lupin's Goa Facility By Michael Mezher - Published 28 April 2017

The US Food and Drug Administration (FDA) has issued an inspection report to major Indian generic drugmaker Lupin Limited following an inspection of its Goa, India facility earlier this month.

Categories: News, India, US, FDA, Generic drugs, Manufacturing

Tags: Form 483, Lupin

FDA Warns Mylan Over Quality System Failures By Zachary Brennan - Published 11 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 3 April to Mylan Pharmaceuticals for its Nashik, India-based manufacturing site, which FDA said does not have a functioning quality system.

Categories: News, India, US, FDA, Drugs, Government affairs, Manufacturing

Tags: Mylan, ARVs, LMIC, HIV, Mylan India

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

Asia Regulatory Roundup: China Unveils Reforms to Simplify Supply Chains, Lower Drug Costs (18 January 2017) By Nick Paul Taylor - Published 18 January 2017

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

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

Asia Regulatory Roundup: CFDA Offers Device Monitoring Guidance (1 November 2016) By Nick Paul Taylor - Published 01 November 2016

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

Categories: News, China, India, CDSCO, CFDA, MHLW, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices

Tags: Asia Regulatory Roundup, adverse event monitoring, device standards, radioactive drugs

CDSCO Advances Draft Medical Device Rules, Outlines Fees By Michael Mezher - Published 26 September 2016

India's Central Drugs Standard Control Organization (CDSCO) on Monday released an updated version of its draft rules for medical devices, including fees payable by industry, after consultations with stakeholders.

Categories: News, India, CDSCO, Medical Devices

Tags: Fees, Draft Medical Device Rules 2016

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

Medical Food & Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities By Manfred Ruthsatz, PhD, Timothy Morck, PhD - Published 01 September 2016

This article addresses current worldwide regulatory challenges and practical opportunities for medical food/Food for Special Medical Purpose (FSMP) to improve the role of nutrition in support of optimal care for patients. It presents the regulatory framework governing this specific category in the US, EU and other parts of the world.

Categories: News, Africa, China, India, Japan, Canada, Europe, Middle East, Oceania, US, FDA, Nutritional and dietary supplements

Tags: Medical Food, Food for Special Medical Purposes

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

India Looks to Further Ease Process of Running Clinical Trials By Zachary Brennan - Published 02 August 2016

India’s Central Drugs Standards Control Organization (CDSCO) on Tuesday looked to relax two clinical trial requirements that could make it easier to run trials there.

Categories: News, India, CDSCO, Clinical, Research and development

Tags: clinical trials in India, clinical investigators

Asia Regulatory Roundup: India Releases Lengthy Draft Legislation on Medical Devices (28 June 2016) By Nick Paul Taylor - Published 28 June 2016

India has released draft legislation about medical devices. The text defines different types of medical devices, categorizes them by risk and establishes a registration process for all except the products that pose the least threat to users.

Categories: News, China, India, CDSCO, CFDA, MHLW, PMDA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Roundup, Asia Regulatory Roundup

EMA Recommends Suspending Alkem Drug Over Flawed Studies By Michael Mezher - Published 24 June 2016

The European Medicines Agency (EMA) on Friday recommended suspending the marketing authorization of a drug made by Indian generic manufacturer Alkem Laboratories over data integrity issues at the company's bioequivalence facility in Taloja, India.

Categories: News, India, Europe, EMA, MHRA, Clinical, Generic drugs, Submission and registration

Tags: Alkem, riluzone, Good Clinical Practice, GCP

Two Indian Contract Pharma, API Manufacturers Refuse FDA Inspections By Zachary Brennan - Published 16 June 2016

The US Food and Drug Administration (FDA) this week added contract manufacturer Cheryl Laboratories’ Navi Mumbai-based manufacturing facility and active pharmaceutical ingredient (API) and intermediate manufacturer Phalanx Labs’ Visakhapatnam-based site to its list of foreign firms that are banned from shipping product to the US because they refused FDA inspections.

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

Tags: API manufacturing, FDA manufacturing inspections