Cadila Healthcare Gets USFDA Approval

Cadila Healthcare on November 21 said Zydus Cadila has received final approvals from the US health regulator for Isosorbide Dinitrate Tablets and Desonide Cream.

Shares of the company were on a shaky track on BSE. The stock traded in the red in the early trade, climbed 2 percent after some time and turned flat again.

Around 11:35 hours IST, shares of the company traded 0.40 percent up at Rs 250.05 on BSE.

“Zydus Cadila has received the final approval from the USFDA to market lsosorbide Dinitrate Tablets USP (US RLD — Isordil Tablet) in the strengths of 5 mg, 10 mg, 20 mg, 30 mg and 40 mg. The group also received the final approval for Desonide Cream (US RLD — Desonide Cream), 0.05 percent,” Cadila Healthcare said in a regulatory filing.

Isosorbide Dinitrate Tablets are used to prevent attacks of chest pain (angina). lt dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump. It will be manufactured at the group’s formulations manufacturing facility at Baddi, the regulatory filing said.

Desonide Cream is a mild corticosteroid, used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash) to reduce swelling, itching and redness that can occur in these types of conditions. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad, said the regulatory filing.

Cadila Healthcare claimed the group now has 278 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003—04.

Zydus Cadila is a global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

Cadila Healthcare is one of the few Indian drugmakers that boasts of having a presence across the spectrum of the pharmaceutical value chain, starting from bulk drugs to formulations, vaccines to biosimilars, and speciality drugs to consumer health.

However, despite these capabilities, it is one of the stocks that has been underperforming in 2019. Shares of the Ahmedabad-based drugmaker dropped 30 percent on the BSE in 2019 compared to a 5.4 percent decline in S&P BSE Healthcare index in the same period.

The first six months of FY20 hadn’t been any great for the company. The EBITDA margins dropped to around 18 percent in H1FY20 compared to 23 percent in the same period of the previous year. The net profit fell 54 percent YoY to Rs 397.7 crore in H1FY20.-Money Control