IPCA, Zydus Cadila major API and formulation makers in India

Over 100 formulators in India, but mainly depend on China for active ingredient

Zydus to increase capacity from 4 MT to 30 MT by next month.

US FDA lifts ban on IPCA labs facilities to source the drug

Intas, McW Healthcare, Macleods, Cipla, Lupin, Abbott India, Unichem, Laurus Labs among makers

US President Donald Trump on Saturday called up Prime Minister Narendra Modi for supply of anti-malaria drug hydroxychloroquine to fight coronavirus infection in American patients. But the reality is that the majority of Indian formulation makers currently are dependent on China for the active pharmaceutical ingredient (API) to make the drug. Over a hundred Indian companies are making or have the capability to produce finished drugs for malaria, but the APIs have to come from China, say sources.

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They said apart from Ipca Laboratories and Zydus Cadila which are the major manufacturers of APIs in India for this drug, other main manufacturers of anti-malarial drugs include companies like Intas Pharmaceuticals, McW Healthcare of Indore, Macleods Pharmaceuticals, Cipla and Lupin from Mumbai. Other API suppliers include Abbott India, Unichem Remedies, Laurus Labs, Vijayasri Organics etc.

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They said while Zydus and Ipca supplies a portion of their API production to these formulators besides for their own production of anti-malarial formulations, about 80-90 per cent of the requirement of hydroxychloroquine are imported from China. "If the API was available for Indian manufacturers at Rs 80,000 per kilogram before the crisis, now it is not available for even Rs 1,50,000 per kilogram and China has virtually stopped supplies," said a joint managing director of a leading Indian drug company, preferring not to be quoted in the story.

"I am not in a position to comment as I am flooded with calls from top government officials and industry from India and abroad. We are assessing the capabilities and supply positions," said Ajit Kumar Jain, Joint Managing Director, IPCA.

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A Zydus Cadila spokesperson said the company is currently the leading supplier to the US market of hydroxychloroquine and has already ramped up its production capacity by about five times to 20 million tonnes (MT) from about 4 MT. Plans are to ramp up production to 30 MT within a month.

The annual report of IPCA for 2018-19 says its API and intermediate sales for the year were Rs 885 crore, of which 77 per cent were exports. If IPCA's total sales in the year were Rs 3,136 crore, anti-malarial drugs as a therapy segment contributed 18 per cent.

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Ipca has also informed the Indian Stock Exchanges that the US FDA (Food and Drug Administration) has allowed the import of hydroxychloroquine sulphate and chloroquine phosphate. Its API manufacturing plant at Ratlam in Madhya Pradesh and two formulation facilities in Pithampur in Madhya Pradesh and Silvassa were under import alert from the US FDA resulting in a ban for over three years. Reportedly, Trump had directed the FDA to "eliminate outdated rules and bureaucracy" to help speed up the pace of testing drugs that could help treat the symptoms of COVID-19.

Chloroquine was discovered in 1934 by Hans Andersag and his team at the Bayer laboratories, but was not used for over a decade as researchers feared that it was too toxic for human use. In 2017, the World Health Organization (WHO) estimated that there were 219 million cases of malaria worldwide, causing 435 thousand deaths, or 1,190 per day, mostly young children.

According to some studies, chloroquine has strong antiviral effects on the coronavirus infection and is currently experimented by many countries in coronavirus treatment and trials are going on to prove its efficacy.

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INDIA CORONAVIRUS TRACKER: BusinessToday.In brings you a daily tracker as coronavirus cases continue to spread. Here is the state-wise data on total cases, fatalities and recoveries in one comprehensive graphic.