Zydus Cadila gets final approval from USFDA for Teriflunomide tablets

It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad, the company said in the filing.

Dec 03, 2018 02:12 IST India Infoline News Service

Cadila Healthcare
Zydus Cadila has received the final approval from the USFDA to market Teriflunomide Tablets (US RLD- AUBAGIO), 7 mg and 14 mg.

It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad, the company said in the filing.


The group now has 237 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04, the company added.

Teriflunomide is used to treat relapsing forms of multiple sclerosis (MS). It is not a cure for MS but is thought to work by decreasing certain immune system cells (lymphocytes) which can attack the nerves in brain and spinal cord. This helps decrease the number of flare-ups (relapses) and may help slow down physical problems caused by MS.

Cadila Healthcare is Ahmedabad based global pharmaceutical company with strong presence in formulations and APIs. In FYQ2FY19, its domestic business contributed 29% of revenue, while US business contributed 45%, the rest 25% was contributed by other businesses. In the domestic market, Cadila has strong portfolio in the cardiovascular, gastrointestinal, gynaecology and respiratory segments.

Cadila has strong ANDA pipeline (185 approved, 135 pending) and expects about 40 product launches in FY18. The FY19E launches of gAsacol, and gToprol XL are not likely to offset the lost market share in gLialda/gTamiflu due to competition. Cadila’s US business is likely to see 8-10% pricing pressure in FY19E, impacting FY19E margins by ~270bps. We expect Cadila to report revenue CAGR of 2% over FY18-20E, while PAT is expected to contract due to the high base/competition in FY18. The stock currently trades at 21.6x FY20E EPS.

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