Zydus Cadila has received final approval from the USFDA to market Liothyronine Sodium Tablets USP, 5 mcg, 25 mcg, and 50 mcg (US RLD: Cytomel Tablets).

Liothyronine is a man-made form of thyroid hormone which is used to treat anunderactive thyroid (hypothyroidism). It replaces or provides more thyroid hormone, which isnormally made by the thyroid gland. The drug will be manufactured at the group's formulationmanufacturing facility at the SEZ, Ahmedabad.

The group now has 312 approvals and has so far filed over 390 ANDAs since the commencement ofthe filing process in FY 2003-04.

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Cadila Healthcare Ltd gained for a third straight session today. The stock is quoting at Rs 493.15, up 1.65% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is up around 0.63% on the day, quoting at 14437.1. The Sensex is at 49119.8, up 0.69%. Cadila Healthcare Ltd has risen around 4.96% in last one month.

Meanwhile, Nifty Pharma index of which Cadila Healthcare Ltd is a constituent, has risen around 7.32% in last one month and is currently quoting at 13271.55, up 0.75% on the day. The volume in the stock stood at 34.95 lakh shares today, compared to the daily average of 34.96 lakh shares in last one month.

The benchmark January futures contract for the stock is quoting at Rs 496.2, up 1.9% on the day. Cadila Healthcare Ltd is up 92.22% in last one year as compared to a 17.09% spurt in NIFTY and a 65.52% spurt in the Nifty Pharma index.

The PE of the stock is 27.32 based on TTM earnings ending September 20.

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Zydus Cadila announced that it will be starting PhaseIII clinical trials of it plasmid DNA vaccine to prevent COVID-19, ZyCoV-D after having received permissions from the DCGI.

The company will now be initiating Phase III clinical trial in around 30,000 volunteers. ZyCoV-D wasfound to be safe, well tolerated and immunogenic in the Phase I/II clinical trials.

The Phase II study of the vaccine ZyCoV-D had been conducted in over 1000 healthy adult volunteers aspart of the adaptive Phase I/II dose escalation, multi-centric, randomized, double-blind placebo controlledstudy. The vaccine was found to be safe and elicit a strong immunogenic response. The trial has reviewedby an independent Data Safety Monitoring Board (DSMB) and reports were submitted to Central DrugsStandard Control Organisation (CDSCO) regularly for the update on safety outcome.

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Zydus Cadila, an innovation-driven global pharmaceutical company today announced that the Drug Controller General of India (DCGI) has approved its New Drug Application (NDA) for Saroglitazar Mg for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD) in India. The prevalence ofNAFLD in India is estimated to be nearly 25-30% of the general population. This approval for NAFLD alongwith either of the comorbidities (Obesity, Type 2 Diabetes Mellitus, Dyslipidemia or Metabolic Syndrome) provides the physicians with a viable treatment option. With a once daily, 4mg dose regimen, Saroglitazar Mg will enable better compliance, reduces the pill burden and offers the patient more convenience.

Saroglitazar Mg was launched in India in September 2013, for the treatment of diabetic dyslipidemiaand hypertriglyceridemia in patients with type-2 diabetes not controlled by statins alone. In Januarythis year, Saroglitazar Mg received an approval for the treatment of Type 2 Diabetes Mellitus. InMarch 2020, Saroglitazar Mg had received approval for the treatment of NASH.

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