HRV Pharma, Metrochem form CDMO alliance for global API manufacturing
HRV Pharma, an active pharmaceutical ingredient (API) manufacturer, has partnered with API development and manufacturing company Metrochem API Private Limited on a multi-year contract development and manufacturing (CDMO) alliance to fast track the development of high-value NCE-1 and speciality APIs for global markets.
HRV Pharma is an India-based integrated virtual API and pharmtech company with a virtual manufacturing model that blends advanced technology with pharmaceutical expertise, according to the company. The multi-year CDMO contract with Metrochem API Private Limited was established for the development, scale-up, and GMP manufacturing of multiple high-value NCE-1 and late-stage complex APIs for regulated and semi-regulated markets.
The collaboration will merge HRV’s global market access and commercial footprint, and its digital, asset-light virtual API platform with MetroChem’s deep process chemistry, scale-up capabilities, and robust GMP infrastructure. The partnership includes a structured pipeline of five initial programs, with additional molecules planned for development under a unified framework.
“This collaboration is a natural extension of HRV’s strategy to build a next-generation, virtual API ecosystem that scales Indian innovation to global markets,” Hari Kiran Chereddi, CEO of HRV Pharma, said in a statement. “MetroChem’s chemistry depth, combined with our global regulatory and market expansion engine, creates a powerful platform for developing and commercializing high-value APIs with speed, quality and predictability.”
Through the agreement, both companies will also execute global regulatory DMF filings (U.S., EU, LATAM, MENA and APAC) with shared technical dossiers; a long-term framework covering novel CNS, metabolic and specialty therapeutic APIs; and a unified quality, compliance and audit readiness program designed for USFDA, EMA, PMDA, ANVISA and other key agencies.
“Partnering with HRV aligns with MetroChem’s vision of moving deeper into complex NCE-1 and advanced API development,” Harsha Nandepu, COO of MetroChem, said in a statement. “Together, we bring complementary strengths strong process chemistry, robust GMP operations, and HRV’s regulatory and global commercial reach. This partnership allows us to meaningfully expand our innovation footprint, monetize our R&D and deliver world-class solutions to global pharma.”
Both organizations will jointly manage CMC documentation, stability studies, validation programs, and global regulatory interactions, creating a seamless development-to-commercialization pathway, according to the announcement.