Alembic Pharma receives USFDA nod for Bromfenac Ophthalmic Solution

Vadodara-based generic drugmaker Alembic Pharmaceuticals on Tuesday announced that it has received final approval from the US Food and Drug Administration (USFDA) for its generic Bromfenac Ophthalmic Solution.

The drug is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

“The approved Abbreviated New Drug Application (ANDA) is deemed therapeutically equivalent to the reference listed drug (RLD), Prolensa Ophthalmic Solution, 0.07 per cent, of Bausch and Lomb,” Alembic said in its statement.

The company now has a cumulative total of 207 ANDA approvals (180 final and 27 tentative approvals) from the US health regulator.

The drug has an estimated market size of $168 million for the twelve months ended March 2024, Alembic said citing IQVIA data.

The drug is expected to be manufactured in Alembic’s manufacturing facilities in Gujarat, according to sources close to the company.

The development comes after the USFDA had issued a Form 483 to the company, with two minor procedural observations following inspection of its injectable and ophthalmic facility (F-3) located at Karkhadi in Gujarat in March last year.

According to the US regulator, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The company had then clarified that none of the observations made were related to data integrity, with the management believing that they are addressable.

Afterwards, it also announced the successful completion of a good manufacturing practice (GMP) audit by the Brazilian Health Regulatory Agency (ANVISA) at its API-III facility in Gujarat without any observations for its active pharmaceutical ingredients (APIs).

On Tuesday, shares of Alembic Pharmaceuticals were down by 9.95 per cent, ending the day's trade at Rs 975 apiece on the Bombay Stock Exchange (BSE).