HYDERABAD: HRV Global Life Sciences has entered a multi-year contract development and manufacturing partnership with MetroChem API Pvt. Ltd. to advance the development and production of high-value NCE-1 and complex APIs for regulated and semi-regulated markets.
According to the announcement, the agreement establishes a framework for exclusive and semi-exclusive development, scale-up and GMP manufacturing of multiple late-stage APIs. The collaboration combines HRV Pharma’s global commercial network and digital, asset-light platform with MetroChem’s process chemistry expertise, scale-up abilities and manufacturing infrastructure.
Under the partnership, the companies will jointly undertake development and scale-up activities for several strategic APIs, including NCE-1 candidates. The scope also includes end-to-end GMP production, validation and supply, along with shared regulatory filings across regions such as the United States, Europe, Latin America, the Middle East and Asia-Pacific. The framework covers programs in CNS, metabolic and specialty therapeutic areas, supported by a unified quality and compliance system intended to meet standards of agencies including the USFDA, EMA, PMDA and ANVISA.
“This collaboration is a natural extension of HRV’s strategy to build a next-generation Virtual API ecosystem,” said Hari Kiran Chereddi, CEO of HRV Pharma. He noted that the combined capabilities are intended to support efficient development and commercialization of high-value APIs.
Harsha Nandepu, COO of MetroChem, said the alliance aligns with the company’s plans to expand in complex NCE-1 and advanced API development, citing complementary strengths in chemistry, GMP operations and regulatory reach.
The agreement begins with a pipeline of five programs, with additional molecules expected to follow. Both organizations will jointly manage CMC documentation, stability studies, validation efforts and regulatory interactions to create a streamlined path from development to commercialization.
