Alembic Pharma JV gets USFDA nod for Diclofenac Sodium Topical Solution

Today, Alembic Pharmaceuticals informed the bourses that its JV, Aleor Dermaceuticals (Aleor), has received a tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated New Drug Application (ANDA) Diclofenac Sodium Topical Solution USP, 2 per cent.

The approved ANDA is a nonsteroidal anti-inflammatory drug, which is used for the treatment of signs and symptoms of osteoarthritis of the knee. Diclofenac Sodium Topical Solution USP, 2 per cent w/w, has an estimated market size of US$974 million for twelve months ending December 2018 according to IQVIA.

Alembic has a cumulative total of 109 ANDA approvals (96 final approvals and 13 tentative approvals) from the USFDA. 

In the recent quarter Q2FY20, the consolidated revenue came in at Rs. 1,240.87 crores against Rs. 1,127.06 crores in the corresponding quarter last year, registering 10.1 per cent YoY increase. The EBITDA for the quarter grew by 14.3 per cent  to YoY Rs. 345.51 crores from Rs. 302.34 crores in the corresponding quarter last year, with a corresponding margin expansion of 102 bps. EBITDA margin for the quarter stood at 27.8 per cent. PAT for the quarter came in at Rs. 246.27 crores as against Rs. 200.07 crores in the corresponding quarter last year with a YoY increase of 23.1 per cent.

The revenue mix as of Q2FY20 stood at API- 16 per cent, Branded- 32 per cent and Generics- 52 per cent. International formulations business grew 10 per cent YoY to Rs. 646 crores. India formulations business for the quarter was Rs. 391 crores from Rs. 385 crores in the last year. API business grew 31 per cent to Rs. 204 crores from Rs. 155 crores in the last year. The US Generics business grew 25 per cent to Rs. 539 crores in the quarter reviewed.

Today, the stock jumped nearly 1 per cent and made an intraday high of Rs. 560.25 on the BSE.