Alembic Pharmaceuticals Limited has achieved significant milestones in its pharmaceutical journey by receiving final approvals from the U.S. Food and Drug Administration (USFDA) for its Dasatinib tablets and Sumatriptan Injection USP. These developments mark crucial steps forward for the company in expanding its presence in the U.S. market.

Key Highlights

Dasatinib Tablets

• Approval Details: Alembic Pharmaceuticals has received USFDA final approval for Dasatinib tablets in six different dosages: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.
• Market Potential: The estimated market size for Dasatinib tablets stands at $1,017.00 million, based on IQVIA data for the twelve months ending September 2023.
• Therapeutic Equivalence: The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to Bristol-Myers Squibb Company's Sprycel Tablets, the reference listed drug (RLD).

Sumatriptan Injection USP

• Approval Details: Alembic Pharmaceuticals received USFDA final approval for Sumatriptan Injection USP in 4 MG/0.5 ML and 6 MG/0.5 ML dosages delivered through a single-dose autoinjector.
• Significance: This represents the company's first drug-device combination product.
• Market Potential: The market size for this product is $73.00 million.

Medical Applications

Dasatinib Tablets

Dasatinib tablets are indicated for the treatment of:

1. Adult patients with:
   • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
   • Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
   • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy
2. Pediatric patients 1 year of age and older with Ph+ CML in chronic phase

Alembic's ANDA Portfolio

These approvals further strengthen Alembic Pharmaceuticals' position in the generic pharmaceutical market. The company now boasts a cumulative total of 227 ANDA approvals from the USFDA, comprising 207 final approvals and 20 tentative approvals.

Company Background

Alembic Pharmaceuticals Limited, founded in 1907, is a vertically integrated research and development pharmaceutical company. With its headquarters in India, Alembic Pharmaceuticals is a publicly listed company that manufactures and markets generic pharmaceutical products globally. The company's state-of-the-art research and manufacturing facilities have received approvals from regulatory authorities of many developed countries, including the USFDA.

Market Impact

The approvals of Dasatinib tablets and Sumatriptan Injection USP are expected to bolster Alembic Pharmaceuticals' position in the U.S. pharmaceutical market. With an estimated market size of over $1 billion for Dasatinib tablets and $73 million for Sumatriptan Injection, these approvals open up significant revenue potential for the company.

As Alembic Pharmaceuticals continues to expand its product portfolio and secure regulatory approvals, it reinforces its commitment to providing high-quality, affordable generic medications to patients worldwide.

Alembic Pharmaceuticals Limited , a prominent player in the Indian pharmaceutical industry, has announced a significant corporate restructuring in its United Arab Emirates (UAE) operations. The company has converted its existing branch office into a wholly owned subsidiary, marking a strategic move to strengthen its presence in the Middle Eastern market.

Key Details of the New Subsidiary

Strategic Implications

This corporate action represents a significant step for Alembic Pharmaceuticals in solidifying its footprint in the UAE market. By converting its branch office into a wholly owned subsidiary, the company aims to:

1. Enhance operational flexibility in the region
2. Potentially expand its product offerings and services in the Middle East
3. Improve its market positioning and competitiveness in the UAE pharmaceutical sector

Transaction Details

The company has clarified that this transaction does not fall under the category of related party transactions. Additionally, it has been stated that the promoter and promoter groups of Alembic Pharmaceuticals have no interest in this newly formed entity.

Regulatory Compliance

In adherence to regulatory requirements, Alembic Pharmaceuticals has made this disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company has duly informed both the BSE Limited and the National Stock Exchange of India Ltd. about this development.

This strategic move by Alembic Pharmaceuticals underscores the company's commitment to expanding its global presence and potentially capitalizing on growth opportunities in the UAE pharmaceutical market.