Alembic Pharma Share Price Rises Nearly 3% On USFDA Approval For Doxycycline

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Alembic Pharmaceuticals\’ share price rose nearly 3 percent intraday to Rs 832.45 on January 4 after the company received the final approval from the US Food & Drug Administration (FDA) for doxycycline hyclate delayed-release tablets.

\”Alembic Pharmaceuticals 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 company said in a press release.

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. Doxycycline  should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria, the release said.

Doxycycline hyclate delayed-release tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg have an estimated market size of USD 10 million for twelve months ending September 2021.

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Alembic has, so far, received 16 approvals—12 final and four tentative —and a total of 155 ANDA approvals—135 final and 20 tentative—from USFDA.

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At 13.18 pm, Alembic Pharmaceuticals was quoting at Rs 829.20, up Rs 19.60, or 2.42 percent, on the BSE. The share touched a 52-week high of Rs 1,119 and on January 13, 2021 and a 52-week low of Rs 720.80 on August 23, 2021. It is trading 25.9 percent below its 52-week high and 15.04 percent above its 52-week low.

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