Alembic Pharmaceuticals Limited , a leading Indian pharmaceutical company, has achieved a significant milestone in its U.S. market expansion. The company announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Paroxetine Extended-Release Tablets in 25 mg and 37.5 mg strengths.

Key Highlights

• The approved Abbreviated New Drug Application (ANDA) is for Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg.
• These tablets are therapeutically equivalent to Apotex Inc.'s Paxil CR Extended-Release Tablets.
• The approval marks Alembic's 226th ANDA approval from the USFDA, including 205 final approvals and 21 tentative approvals.

Therapeutic Applications

The newly approved Paroxetine Extended-Release Tablets are indicated for the treatment of several mental health conditions:

• Major depressive disorder (MDD)
• Panic disorder (PD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD)

Company Profile

Alembic Pharmaceuticals Limited, established in 1907, is a vertically integrated research and development pharmaceutical company. The company has a strong presence in the Indian market and is expanding its global footprint, particularly in the United States.

Market Impact

This approval strengthens Alembic's position in the U.S. generic pharmaceuticals market. The company's growing portfolio of USFDA-approved products demonstrates its commitment to expanding its presence in key international markets.

Alembic Pharmaceuticals' shares are listed on the National Stock Exchange of India (NSE: APLLTD) and the Bombay Stock Exchange (BSE: 533573).

The approval of Paroxetine Extended-Release Tablets adds to Alembic's diverse product portfolio and may contribute to the company's revenue growth in the coming quarters. As always, patients should consult with their healthcare providers regarding the use of any new medication.

Alembic Pharmaceuticals Limited (APL) has announced a significant development in its regulatory compliance efforts. The company has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its API-I and API-II facilities located in Panelav.

Inspection Details

The US FDA conducted an inspection of APL's Panelav facilities from May 26 to May 31. This thorough examination of the company's Active Pharmaceutical Ingredient (API) manufacturing units is a crucial step in ensuring compliance with US regulatory standards.

Official Notification

APL officially informed the Bombay Stock Exchange (BSE) and the National Stock Exchange of India (NSE) about receiving the EIR on September 13. The company's prompt disclosure aligns with its commitment to transparency and regulatory compliance.

Significance of the EIR

Receiving an Establishment Inspection Report from the US FDA is a notable milestone for pharmaceutical companies. It typically indicates that the FDA has completed its inspection and found the facilities to be in an acceptable state of compliance with current good manufacturing practice (cGMP) regulations.

Impact on Alembic Pharmaceuticals

The successful completion of this inspection and receipt of the EIR could potentially strengthen Alembic Pharmaceuticals' position in the global pharmaceutical market, particularly in the United States. It may enhance the company's credibility and could be viewed positively by stakeholders and potential partners.

Company's Response

Manisha Saraf, Company Secretary of Alembic Pharmaceuticals Limited, signed the official communication to the stock exchanges, underlining the importance of this development for the company.

This latest regulatory milestone comes as part of Alembic Pharmaceuticals' ongoing efforts to maintain high standards of quality and compliance in its manufacturing processes, particularly for its API facilities which play a crucial role in the pharmaceutical supply chain.