Alembic Pharma Secures USFDA Approval For Groundbreaking Bromfenac Ophthalmic Solution

On Tuesday, Alembic Pharmaceuticals, a generic drug manufacturer based in Vadodara, announced it has secured final approval from the US Food and Drug Administration (USFDA) for its generic version of Bromfenac Ophthalmic Solution. This nonsteroidal anti-inflammatory drug (NSAID) is used to treat postoperative inflammation and reduce ocular pain in patients who have undergone cataract surgery.

Alembic said in its statement, “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.”

The company has now secured a cumulative total of 207 ANDA approvals from the US health regulator, which includes 180 final approvals and 27 tentative ones. Alembic cited IQVIA data indicating that the drug has an estimated market size of $168 million for the twelve months ending March 2024. Sources close to the company revealed that the drug is expected to be manufactured at Alembic’s facilities in Gujarat.

This development follows the issuance of a Form 483 by the USFDA to the company. The form, which included two minor procedural observations, was issued after an inspection of Alembic's injectable and ophthalmic facility (F-3) in Karkhadi, Gujarat, in March of the previous year. According to the US regulator, a Form 483 is presented to a company's management at the end of an inspection when the investigator has noted conditions that may violate the Food Drug and Cosmetic (FD&C) Act and related Acts.

The company clarified that none of the observations pertained to data integrity, and management believes they can be addressed. Subsequently, the company 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, with no observations noted for its active pharmaceutical ingredients (APIs). On Tuesday, Alembic Pharmaceuticals' shares fell by 9.95 percent, closing at Rs 975 each on the Bombay Stock Exchange (BSE).