Aurobindo Pharma gains as its arm receives USFDA’s approval for Diclofenac Sodium Topical Solution USP

Aurobindo Pharma is currently trading at Rs. 423.00, up by 4.35 points or 1.04% from its previous closing of Rs. 418.65 on the BSE.

aurobindo pharma gets usfdas nod for guaifenesin extended release tablets
Aurobindo Pharma

The scrip opened at Rs. 419.10 and has touched a high and low of Rs. 424.15 and Rs. 415.35 respectively. So far 34505 shares were traded on the counter.

The BSE group ‘A’ stock of face value Rs. 1 has touched a 52 week high of Rs. 730.00 on 25-Mar-2022 and a 52 week low of Rs. 397.30 on 03-Feb-2023.

Last one week high and low of the scrip stood at Rs. 424.15 and Rs. 397.30 respectively. The current market cap of the company is Rs. 24624.07 crore.

The promoters holding in the company stood at 51.83%, while Institutions and Non-Institutions held 37.21% and 10.96% respectively.

Aurobindo Pharma’s step down subsidiary — Aurolife Pharma LLC has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Diclofenac Sodium Topical Solution USP, 2% w/w, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Pennsaid Topical Solution, 2% w/w of Horizon Therapeutics Ireland DAC (Horizon). The product is expected to be launched in Q1FY24.

The approved product has an estimated market size of around $487 million for the twelve months ending December 2022, according to IQVIA.

This is the first ANDA to be approved out of the Aurolife Unit-II, North Carolina, USA, used for manufacturing topical products. Aurobindo now has a total of 430 ANDA approvals (404 Final approvals and 26 tentative approvals) from USFDA.

Diclofenac Sodium Topical Solution USP, 2% w/w is Indicated for the treatment of the pain of osteoarthritis of the knee(s).

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

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