Ipca and Cadila Healthcare gear up to make drug for coronavirus

In a notification to the BSE, Ipca on Saturday said the USFDA had made an exception to the import alert to its plants for the products in question | File Photo
Hydroxychloroquine, a drug whose largest manufacturer is an Indian firm, has shot into the limelight after the US president advocated it as potential therapy for COVID-19.

Ipca is the biggest producer of the drug. Cadila Healthcare, based in Ahmedabad, too is a major player. Both are gearing up to meet the demand and have said there will be enough supplies.

On top of this, a combination hydroxychloroquine and azithro­mycin, a common antibiotic, is being considered.

Vadodara-based drug major Alembic is the domestic market leader with its brand Azithral, with an almost 30 per cent share.

Sources said the country’s apex health research body, the Indian Council of Medical Research (ICMR), had included the drug in its protocol for treating COVID-19. The ICMR, however, has not confirmed this.

Pankaj Patel, chairman of Cadila Healthcare, said the firm was producing 20 tonnes of Hydroxy­chloroquine per month, and had started ramping up production.

He said the country could make 100 tonnes of the drug per month immediately.

“We are ramping up our capacity and are geared up to supply enough for the Indian market. There would be no shortage of this drug here. Moreover, most of the raw material used is fortunately available locally,” he added.

Meanwhile, there is demand pouring in for Ipca Laboratories. The US Food and Drug Administration (USFDA) has relaxed the import alert imposed on its plants for the active pharmaceutical ingredient (API) and the finished product of hydroxychloroquine sulphate and chloroquine phosphate.

In a notification to the BSE, Ipca on Saturday said the USFDA had made an exception to the import alert to its plants for the products in question. APIs for hydroxychloroquine sulphate and chloroquine phosphate are produced at Ipca’s Ratlam unit, Madhya Pradesh, while the formulation is produced at Pithampur, Madhya Pradesh, and Piparia, Silvassa (headquarters of Dadra and Nagar Haveli).

Analysts said the company’s stock would see an upside as a result. Ipca’s plants are under the USFDA’s import alert for the past three years.

The USFDA has, however, said the exception would be re-considered if the shortage implications changed.

Several research papers and articles have said the drugs have treatment potential.

“Due to this, we are noticing an increase in emergency demand and enquiries for the chloroquine phosphate and hydroxy­chloro­quine sulphate APls and its formulations from several countries world over. Forseeing this increased demand, Ipca being amongst largest manufacturer, vertically integrated with capacities and capabilities for manufacturing of these APls and its formulations, is gearing to manufacture and supply these products meeting the stringent cGMP, quality and regulatory requirements and thus help mankind in the best possible way in these testing times,” the company said.

A senior company executive said hydroxychloroquine was used to treat rheumatoid arthritis and also as third-line therapy for diabetes.

“The drug’s safety profile is thus well established,” he added.

Ipca used to make 600 tonnes of chloroquine phosphate, an anti-malarial drug, a year, and had an 80 per cent share of the global market. However, the demand for the drug has reduced with cases relating to the particular malaria variant coming down.

“President Donald Trump has mentioned both the drugs for treating COVID-19 and we can easily ramp up manufacturing as demand scales up,” he said.

Meanwhile, Alembic has indicated there is enough material to make azithromycin till June and supplies from China have started coming.

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