Alembic Pharma Expands DifGen Partnership to Tap USD 5 Billion US Complex Generics Market
New Delhi: Alembic Pharmaceuticals Limited has expanded its strategic collaboration with DifGen Pharmaceuticals to strengthen its presence in the US complex generics market, with a portfolio of more than 20 differentiated products targeting an aggregate reference market of approximately USD 5 billion.
Under the expanded collaboration, DifGen will leverage its drug development, regulatory, US manufacturing and supply capabilities, while Alembic will contribute its established US commercial platform. Alembic will also manufacture select products under the arrangement.
The expanded partnership builds on the companies' existing relationship, which includes a joint venture in Canada.
The proposed portfolio spans multiple complex dosage forms, including injectables, transdermal systems, ophthalmic products, oral formulations and other specialised drug delivery formats.
According to the companies, the portfolio includes first-to-file (FTF) opportunities, potential Day 1 launches and products expected to face limited competition, offering opportunities for higher-value growth and faster market access in the US.
Initial product launches are expected to begin in FY28. The collaboration is expected to provide revenue visibility in the near term, with the potential to progressively increase its contribution to Alembic's US business as additional products are commercialised over the coming years.
The agreement also provides Alembic with reserved manufacturing capacity at DifGen's US facilities, along with a framework to gradually build US manufacturing capabilities for select dosage forms.
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Commenting on the expanded collaboration, Pranav Amin, Managing Director of Alembic Pharmaceuticals Limited, said the partnership would further strengthen the company's complex generics franchise in the US.
He noted that the expanded portfolio would increase Alembic's exposure to differentiated opportunities, particularly in transdermal systems, complex injectables and other specialised dosage forms.
Amin added that the collaboration would provide access to near-term commercial opportunities and US manufacturing capabilities, while offering a capital-efficient approach to expanding the company's pipeline and supporting sustainable growth in its US business.
Alembic Pharmaceuticals Limited is an India-based, vertically integrated pharmaceutical company with a presence in research, development, manufacturing and marketing of generic medicines worldwide.
Established in 1907 and headquartered in India, the publicly listed company operates research and manufacturing facilities approved by regulatory authorities in several developed markets, including the US Food and Drug Administration (USFDA).
