Key Highlights:
- Gland Pharma and Neuland Laboratories entered a long-term strategic CDMO partnership to strengthen sterile API manufacturing, with Gland establishing a dedicated sterile manufacturing suite at its JNPC facility in Visakhapatnam.
- The collaboration combines Neuland’s expertise in complex API development with Gland’s sterile manufacturing and regulatory capabilities to deliver integrated development, scale-up, regulatory support, and commercial manufacturing for sterile APIs used in microparticle depot products.
- The new facility, built to cGMP, US FDA, and EU standards, is expected to add around 1,400 kg of annual sterile API capacity, enhancing global supply resilience and meeting rising demand for complex injectable therapies
Implications:
The new cGMP/US FDA/EU-compliant suite at Gland’s Visakhapatnam JNPC site, adding ~1,400 kg/year of sterile API capacity, should help both companies capture more of the high-value sterile API CDMO market and improve supply resilience for global customers. Long term, this can strengthen their positioning in complex injectables, support scale-up of late-stage programs, and provide a more integrated development-to-commercial offering that is attractive to sponsors needing reliable, regulated sterile manufacturing in India.
Source: ExpressPharma
