Alembic Pharmaceuticals has executed a Shareholders' Agreement to invest in a newly incorporated Canadian Corporation, securing a 45% equity stake to establish a platform for the development and commercialization of pharmaceutical products in the Canadian market. The agreement was signed on June 6, 2026, with Difgen Holdings LLC and Mr. Sukhad Juneja to invest in the shares of 17989377 Canada Inc. Post-investment, the Canadian Corporation will become an associate of Alembic Pharmaceuticals.

Joint Venture Structure

The joint venture involves Alembic Pharmaceuticals and Difgen Holdings LLC each holding a 45% shareholding, while others will hold the remaining 10%. The board of directors of the Canadian Corporation will comprise nominee directors of the shareholders along with an independent director. The agreement provides for customary shareholder rights, including participation in key decision matters.

Shareholding Pattern

Regulatory Compliance

The disclosure was made to the stock exchanges pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The filing confirmed that the parties to the joint venture are not related to the promoter, promoter group, or group companies of Alembic Pharmaceuticals in any manner. Furthermore, the investment does not fall within the purview of a Related Party Transaction for the company. The document also confirmed that there is no potential conflict of interest arising out of this agreement, and the specific details regarding the issue price and class of shares were noted as not applicable in the regulatory filing. Manisha Saraf, Company Secretary of Alembic Pharmaceuticals, submitted the intimation to BSE Limited and the National Stock Exchange of India Ltd.

Alembic Pharmaceuticals has received final approval from the United States Food and Drug Administration (USFDA) for Haloperidol Tablets across various dosages. This regulatory clearance represents a notable addition to the company's US generics portfolio and opens access to an established pharmaceutical segment in the American market.

Regulatory Approval Details

The USFDA's final approval covers Haloperidol Tablets in multiple dosage strengths. The following table summarizes the key details of this approval:

Market Opportunity

The projected market size for Haloperidol Tablets in the United States is estimated at $27 million by FY26. This approval positions Alembic Pharmaceuticals to participate in this market segment, further strengthening its presence in the US generics landscape.

Haloperidol is an established antipsychotic medication widely used in the treatment of various psychiatric conditions, making it a recognized product category within the US pharmaceutical market. The final USFDA approval enables Alembic Pharmaceuticals to commercialize the product in the United States across the approved dosage forms.