News
Gland Pharma and Neuland Laboratories Have Just Signed a Long-Term Strategic CDMO Partnership — A Dedicated Sterile Suite in Visakhapatnam for Microparticle Depot APIs
By Mustafa Shariff, Editor in Chief · August 07,2026 · 2 mins read
Summary
- Gland Pharma and Neuland Laboratories Sign Long-Term CDMO Partnership for Sterile API Manufacturing — Dedicated Suite at Visakhapatnam JNPC Facility
- Gland Pharma and Neuland Laboratories announced a long-term strategic CDMO partnership on August 5, 2026, establishing a dedicated sterile manufacturing suite at Gland's Visakhapatnam JNPC facility for microparticle depot APIs, to cGMP, USFDA and EU standards.
Gland Pharma Limited and Neuland Laboratories Limited announced on August 5, 2026, a long-term strategic CDMO partnership that will create a dedicated, integrated manufacturing platform for sterile Active Pharmaceutical Ingredients — particularly those used in microparticle depot products. The announcement marks a significant expansion of the relationship between two of Hyderabad's most respected pharmaceutical manufacturers, combining Neuland's complex API development and manufacturing expertise with Gland Pharma's globally recognised sterile manufacturing capability.
Under the terms of the partnership, Gland Pharma will expand its existing sterile manufacturing infrastructure by constructing an additional dedicated suite at its JNPC (Jawaharlal Nehru Pharma City) facility in Visakhapatnam, Andhra Pradesh, specifically to support Neuland's growing demand for sterile APIs. The facility will be designed, constructed, and operated to current Good Manufacturing Practice (cGMP) standards, United States FDA requirements, and European Union pharmaceutical manufacturing regulations — reflecting the regulatory markets that both companies' global customer bases serve.
What Microparticle Depot APIs Are
Microparticle depot products — the specific API category that this partnership prioritises — represent one of the most technically demanding categories in pharmaceutical development and manufacturing. Depot formulations are designed to release their active pharmaceutical ingredient slowly and continuously over days, weeks, or months after a single injection, eliminating the need for daily dosing. The best-known examples include extended-release formulations of risperidone, naltrexone, and leuprolide — products whose clinical utility depends entirely on precise and consistent API release kinetics maintained through the integrity of the microparticle matrix.
The manufacturing of APIs intended for microparticle depot products requires the combination of complex synthetic chemistry (to produce the API itself) and sterile manufacturing capability (because the API will ultimately be processed into an injectable depot formulation that must meet the strictest sterility assurance requirements). This combination is precisely what the Gland-Neuland partnership brings together: Neuland's complex API synthesis capability and Gland's sterile manufacturing infrastructure.
Complementary Capabilities
The strategic logic of the partnership rests on the complementarity of both companies' core strengths. Neuland Laboratories has built its business as one of India's premier complex API manufacturers — with particular expertise in complex chemistry, process development, custom manufacturing, and increasingly, peptide API manufacturing. Neuland's March 2026 commercial peptide facility launch (Module 1 at its Bonthapally campus, with approximately $30 million in committed demand at opening) demonstrated the company's commitment to serving the growing global demand for complex peptide APIs.
Gland Pharma — backed by Shanghai Fosun Pharmaceutical, and managing director Srinivas Sadu — has built one of India's most respected sterile injectable manufacturing platforms, with global regulatory credentials including USFDA and EMA approval across multiple facilities. Gland's 2022 acquisition of Cenexi, a European CDMO specialising in sterile liquid and lyophilised fill-finish drug products, further deepened its European sterile manufacturing presence.
Saharsh Davuluri: The Integration Value Proposition
Saharsh Davuluri, CEO of Neuland Laboratories, articulated the commercial value proposition of the combined platform clearly: through this partnership with Gland Pharma, the companies are combining Neuland's expertise in complex APIs with Gland's proven sterile manufacturing capabilities to create a differentiated platform for global customers. Together, the companies will offer an integrated CDMO solution encompassing development, scale-up, regulatory filings, and commercial manufacturing — serving the full spectrum of global pharmaceutical innovators and generic companies that require reliable, quality-assured sterile API supply.
The Strategic Backdrop: India's CDMO Capability Deepening
The Gland-Neuland partnership is the latest addition to a rapidly deepening Indian CDMO collaboration landscape that BHC Media has tracked throughout 2026. Piramal Pharma Solutions + Ajinomoto Bio-Pharma Services for ADC manufacturing (covered August 3 edition), Laurus Labs' 67% CDMO revenue growth (July 27 edition), OneSource's 37% revenue growth from semaglutide CDMO commercialisation (July 27 edition) — together describe an Indian CDMO sector that is systematically building the integrated, multi-capability platforms that global pharmaceutical customers increasingly require. The BIOSECURE Act's customer qualification wave is creating sustained demand for exactly this kind of integrated, regulatory-ready Indian CDMO capability.
BHC Perspective
At Bengaluru Health Community, the Gland-Neuland CDMO partnership is a story about two well-established Indian pharmaceutical companies creating something together that neither can achieve independently. Integrated sterile API CDMO capability for microparticle depot products — built to USFDA and EU standards from combined Hyderabad infrastructure — is precisely the kind of specialised, high-value CDMO offering that global pharmaceutical innovators need and that the Indian CDMO sector is uniquely positioned to provide.
Frequently Asked Questions
Q: What did Gland Pharma and Neuland Laboratories announce?
A: A long-term strategic CDMO partnership (August 5, 2026) under which Gland will construct a dedicated sterile manufacturing suite at its JNPC Visakhapatnam facility for APIs used in microparticle depot products, to be built and operated to cGMP, USFDA, and EU standards. Neuland brings complex API expertise; Gland brings sterile manufacturing capability.
Q: What are microparticle depot products?
A: Injectable drug formulations that release their API slowly over days, weeks, or months after a single injection (extended-release depots). Examples include extended-release formulations of risperidone, naltrexone, and leuprolide. Manufacturing requires complex API synthesis combined with sterile manufacturing to meet strict sterility assurance requirements.
Q: How does this fit the Indian CDMO landscape?
A: Part of a deepening Indian CDMO collaboration landscape alongside Piramal-Ajinomoto (ADC), OneSource-Formycon (biosimilars), and Laurus Labs' 67% CDMO growth. India is building integrated, multi-capability CDMO platforms serving global pharmaceutical customers — benefiting from BIOSECURE Act-driven customer diversification away from Chinese CDMOs.