Alembic Pharma dips by 2 per cent despite USFDA approvals
Alembic Pharma has received two approvals from the US Food & Drug Administration (USFDA) for Dorzolamide Hydrochloride Ophthalmic Solution USP, 2% and also for Fenofibrate Tablets USP, 48 mg and 145 mg. Despite this development, the stock of the company was down by 2.22 per cent.
The approved Abbreviated New Drug Application (ANDA) for Dorzolamide Hydrochloride Ophthalmic Solution USP, 2% is an equivalent to reference listed drug product (RLD) Trusopt Ophthalmic Solution, 2%, of Merck Sharp & Dohme Corp. It is a carbonic anhydrase inhibitor used for treating elevated intraocular pressure in patients who are suffering with ocular hypertension or open-angle glaucoma. According to IQVIA, the approximate market size for 12-month ending December 2018 of the drug is US$35 million.
The company also received a second ANDA approval for Fenofibrate Tablets USP, 48 mg and 145 mg is an equivalent to reference listed drug product (RLD) Tricor Tablets, 48 mg and 145 mg, of AbbVie Inc. (AbbVie). The tablets are an adjunctive therapy to diet for reducing elevated LDL and Total Cholesterol levels, triglycerides and also increasing high-density lipoprotein cholesterol (HDLC) in patients suffering from either hypercholesterolernia or mixed dyslipidemiaor severe hypertriglyceridemia. According to IQVIA, the approximate market size for 12-month ending December 2018 of this tablet is US$94 million.
Alembic Pharmaceutical is a pharma company conducting research and development along with manufacturing and marketing generic pharma products in domestic as well as foreign markets. Currently, the company has 101 ANDA approvals Alembic now has a total of 101 ANDA approvals (89 final approvals and 12 tentative approvals) from USFDA of which 89 are final approvals and 12 are tentative approvals.
On Tuesday, the stock of the company was last seen trading at Rs. 533.50 per share, down by 2.22 per cent or Rs. 11.85 per share. The 52-week high is Rs. 664 and 52-week low is Rs. 435.10 on BSE.