Stock Report

Alembic Pharmaceuticals receives USFDA Final Approval for Doxycycline Hyclate Delayed-Release Tablets

Posted On : 2022-01-04 11:08:27( TIMEZONE : IST )

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Delayed-Release Tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Doryx Tablets, 75 mg, 100 mg, 150 mg, and 200 mg, of Mayne Pharma International Pty. Ltd. (Mayne). Doxycycline Hyclate Delayed-Release Tablets are indicated' to reduce the development of drug resistant bacteria and maintain the effectiveness of Doxycycline Hyclate DelayedRelease Tablets and other antibacterial drugs, Doxycycline Hyclate DelayedRelease Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Wher:, culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Doxycycline Hyclate Delayed-Release Tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg have an estimated' market size of US$ 10 million for twelve months ending September 2021 according to IQVIA.

Alembic has received year to date (YTD) 16 approvals (12 final approvals and 4 tentative approvals) and a cumulative total of 155 ANDA approvals (135 final approvals and 20 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 809.60 as compared to the previous close of Rs. 802.65. The total number of shares traded during the day was 47946 in over 1184 trades.

The stock hit an intraday high of Rs. 810.00 and intraday low of 801.80. The net turnover during the day was Rs. 38786659.00.