FDA approves 59 products to 37 new Cos to produce Azithromycin

The state earlier had 615 companies which are manufacturing azithromycin

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FDA approves 59 products to 37 new Cos to produce Azithromycin

The Gujarat Food and Drug Control Administration (FDCA) has given approval to 59 product licenses to 37 manufacturers to produce azithromycin which is given to COVID-19 patients as a standard treatment protocol.

As per the clinical management protocol, hydroxychloroquine (HCQ) in combination with azithromycin is to be considered as an off-label indication only in patients with severe COVID-19 under close medical supervision, according to Union health ministry.

615 companies manufacturing azithromycin

“The state earlier had 615 companies which are manufacturing azithromycin. Besides this, the state drug regulator today has a total of 141 hydroxychloroquine manufacturers from the earlier 29 HCQ manufacturers before March 21, 2020. Most of these HCQ manufacturers which produce in both 200 and 400 milligram (mg) dosage form are mostly export oriented,” informed Gujarat FDCA Commissioner Dr HG Koshia.

Gujarat was the first state in the country to do a stockpiling of 53 lakh HCQ tablets as a precautionary measure to COVID-19, he further added. The state had procured another one crore tablets to cater to the COVID-19 patients and healthcare workers. HCQ which is now a Schedule H1 drug is required for prophylactic use for healthcare workers and for people exposed to COVID-19 positive cases besides its wide therapeutic use.

Also read: Pfizer and BNTECH start dosing patients

Prices of APIs

The prices of active pharmaceutical ingredients (APIs) of azithromycin and HCQ have increased two to ten times due to sharp rise in their demand to fight against COVID-19 pandemic. The prices of azithromycin have jumped to Rs. 16,000 per kg from Rs. 9,000 per kg earlier. The API is imported from China. Taking a cue from Indian traders, the Chinese exporters have also increased the prices of azithromycin to US$ 150 a kg from US$ 90 per kg earlier. On the other hand, the prices of HCQ API have gone up ten times to Rs. 70,000 a kg from Rs. 7,000 per kg earlier.

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