SAN DIEGO, CA / ACCESS Newswire / September 25, 2025 / Bora Biologics, a leading contract development and manufacturing organization (CDMO) specializing in biologics, proudly announces its partnership with InvaGen Pharmaceuticals Inc., a wholly owned subsidiary of Cipla Limited, for the manufacture of NYPOZI™ (biosimilar to Neupogen®) at its FDA-registered facility in San Diego, California.
This collaboration signifies a major advancement in the biopharmaceutical sector, as NYPOZI™ is set to become the first FDA-approved biosimilar developed by a Taiwanese biopharma company to launch in the U.S. market. Bora Biologics will leverage its U.S. commercial manufacturing capabilities to support the production of this innovative therapy.
Bora Biologics' San Diego facility is equipped with advanced technology and rigorous GMP processes, enabling the efficient manufacture of high-quality biologics. This partnership underscores Bora Biologics' commitment to meeting the growing demands of the biopharmaceutical industry while ensuring the highest standards of quality and compliance.
"We are thrilled to be InvaGen's manufacturing partner for NYPOZI™ in the United States," said Stephen Lam, CEO of Bora Biologics. "Our FDA-registered facility is designed to meet the stringent requirements of biologics manufacturing, and we are dedicated to supporting this product's journey to market making more affordable medicine available to patients."
Marc Falkin, CEO, Cipla North America commented, "Our foray into the U.S. biosimilars signals a key milestone for Cipla. We are pleased to work with Bora Biologics to manufacture NYPOZI™ (biosimilar to Neupogen®) and improve access to high-quality affordable treatment. This further aligns with our purpose of ‘Caring for Life' by making advanced therapies available to those in need, ultimately enhancing patient outcomes in the US."
This collaboration represents a significant milestone in Bora Biologics' mission to provide comprehensive manufacturing solutions and contribute to the advancement of life-saving therapies within its expanding GMP facility with two new 2000L bioreactors for biologics manufacturing opening in Q1 2026.
About Bora Biologics
Bora Biologics is a global CDMO offering agile, comprehensive end-to-end solutions for biopharma companies worldwide. With a proven track record of over 100 successful cGMP manufacturing batches, Bora Biologics leverages its state-of-the-art, FDA-registered facility in the U.S. and deep expertise in biologics development and manufacturing-including its own FDA-licensed and Health Canada approved product-to enhance time and cost efficiencies while ensuring effective pathways to market for its clients. Bora Biologics combines innovative early-phase development and late-stage manufacturing capabilities with the expertise and reputation of Bora Pharmaceuticals for flexible and scalable fill/finish services, including stability testing and final packaging of clinical and commercial products. Bora Biologics is a dba of Tanvex BioPharma USA, Inc.
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SOURCE: Bora Biologics
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