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FDA ‘Exception’ For Ipca’s Chloroquine/HCQ Amid Supply Plans From Others

 
• By Anju Ghangurde

Import alert hit-Ipca gets a temporary reprieve from US FDA for supplies of hydroxychloroquine sulphate and chloroquine phosphate, the antimalarials in the spotlight as potential treatments for COVID-19. But with many firms committing to supplies/donations, analysts appear to be tempering enthusiasm for large windfall gains for the Indian firm.

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Temporary FDA Reprieve For IPA's Chloroquine, HCQ • Source: Shutterstock

Indian firm Ipca Laboratories Ltd., whose formulations manufacturing sites in Silvassa and the Special Economic Zone in Indore and an active pharmaceutical ingredients (APIs) unit in Ratlam had been placed under import alert by the US Food and Drug Administration, has received a temporary breather from the agency for hydroxychloroquine sulphate and chloroquine phosphate, the antimalarials being evaluated as potential treatments for coronavirus. (Also see "Ipca On Tailspin After Three-Plant FDA Ban" - Scrip, 16 June, 2017.)

Ipca informed Indian stock markets that the FDA had indicated it had “made exception” to the enforcement action for the...

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Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
• By Anju Ghangurde

Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

More from Asia

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges

Welireg Among Japan Recommendations; Economic Policy Raises Hopes Of Higher Prices

 
• By Lisa Takagi

Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.

Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.