Alembic Pharmaceuticals Strengthens Strategic Collaboration With DifGen To Expand Its Complex Generics Portfolio In The US

Alembic Pharmaceuticals Limited ("Alembic") today announced the expansion of its strategic collaboration with DifGen Pharmaceuticals ("DifGen").

Building on their existing relationship, including the joint venture in Canada, the expanded collaboration combines DifGen’s development and US manufacturing capabilities with Alembic’s established US commercial platform. DifGen will lead development, regulatory, manufacturing and supply activities, while Alembic will manufacture select products and commercialise the portfolio in the US.

Key highlights of the collaboration:

• Broad, differentiated complex generics portfolio: portfolio of 20+ differentiated products across injectable, transdermal, ophthalmic, oral and other complex dosage forms addressing an aggregate reference market of ~US$5B.
• Higher value opportunities and faster market access: portfolio includes open FTF opportunities, potential Day 1 launches and products with limited expected competition.
• Near term revenue visibility with potential to scale: initial launches are expected from FY28, providing near-term revenue visibility and a platform for progressively increasing contribution to the US business as the broader portfolio is commercialised over the next few years.
• US manufacturing optionality: reserves capacity for Alembic at DifGen’s US facilities, with a framework to progressively build US manufacturing capacity for select dosage forms.

Commenting on the collaboration, Mr. Pranav Amin, Managing Director, Alembic Pharmaceuticals Limited, said, “This collaboration further strengthens our complex generics franchise in the US. The portfolio expands Alembic’s exposure to differentiated opportunities, particularly in transdermal systems, complex injectables and other specialised dosage forms. Importantly, the collaboration provides near-term commercial opportunities and access to US manufacturing capabilities. We believe this is a capital efficient way to deepen our pipeline, strengthen the quality, and sustainability of Alembic’s US business growth and create long-term value for our stakeholders.”

About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the US FDA. Alembic is one of the leaders in branded generics in India. For more information, visit www.alembicpharmaceuticals.com.