Neuland Expands Commercial Peptide Manufacturing With 6,370-Litre Facility at Bonthapally

Hyderabad-based Neuland Laboratories is expanding its commercial peptide manufacturing capabilities with a dedicated facility at Bonthapally in Telangana, adding 6,370 litres of combined solid-phase and liquid-phase peptide synthesis reactor capacity in its first module.

The new facility is designed to support pharmaceutical and biotechnology companies as peptide programmes move from development and clinical manufacturing into larger commercial volumes. Neuland says the site has been developed as a modular manufacturing complex, allowing capacity to be expanded as customer requirements increase.

6,370 Litres of Peptide Reactor Capacity

The first module combines solid-phase peptide synthesis, or SPPS, and liquid-phase peptide synthesis, or LPPS, giving Neuland the ability to handle different types and lengths of peptide molecules using the manufacturing route best suited to each product.

The company’s SPPS capability includes reactors of up to 500 litres, with the facility designed to accommodate future expansion to 2,000-litre synthesisers. Its LPPS infrastructure includes reactors ranging from 250 litres to 3,000 litres, with provision for additional 5,000-litre glass-lined reactors as demand grows.

Neuland says the infrastructure is intended to support programmes from smaller clinical batches through to commercial-scale production without requiring customers to shift manufacturing platforms as their products advance.

Dedicated Greenfield Peptide Manufacturing Site

The peptide facility has been developed at Bonthapally, near Hyderabad, on a five-acre site.

According to Neuland, the greenfield plant has been designed around four modular manufacturing units and uses Distributed Control System-based automation. The company says this allows production to be scaled from tens of kilograms to more than 100 kilograms annually depending on the molecule and process involved.

The facility also supports more than 40 amino-acid coupling steps and incorporates downstream operations such as precipitation, crystallisation, spray drying and lyophilisation.

This integrated setup is intended to allow peptide synthesis, purification and final processing to be performed within the same manufacturing environment.

Solid-Phase and Liquid-Phase Manufacturing Under One Roof

Peptides can require substantially different manufacturing approaches depending on their length and molecular complexity.

Neuland uses SPPS primarily for peptides containing roughly five to 60 amino acids, while LPPS is particularly suited to shorter peptides that need to be manufactured at larger scale.

For more complex molecules, the company also uses hybrid approaches combining solid-phase and liquid-phase techniques, including segment condensation and ligation. Neuland says its capabilities cover linear peptides, cyclic peptides, PEGylated and lipidated molecules, azido peptides and peptide fragments.

Bringing these capabilities together within a dedicated commercial facility gives the company greater flexibility when transferring molecules from development laboratories into manufacturing.

Peptide Manufacturing Demand Continues to Rise

Neuland’s investment comes as peptide-based medicines are becoming an increasingly important part of the global pharmaceutical pipeline.

The company says demand is being driven by the expansion of peptide therapeutics across areas such as metabolic diseases, oncology and other specialised treatments. GLP-1 therapies in particular have placed additional pressure on global peptide manufacturing capacity.

For pharmaceutical companies, peptide manufacturing presents a particular challenge because large-scale synthesis requires tightly controlled chemistry, purification and analytical systems. This has increased demand for specialised contract development and manufacturing organisations capable of taking peptide programmes from early development through commercial supply.

Neuland has more than 15 years of peptide development experience and says its capabilities cover molecules ranging from five to 120 amino acids using SPPS, LPPS and hybrid synthesis routes.

Commercial-Scale Purification and Drying Systems

The Bonthapally facility includes equipment intended specifically for large-scale peptide purification.

Neuland lists multiple preparative chromatography systems, including 45-centimetre and 60-centimetre DAC columns, with provision for further expansion. It has also installed commercial-scale lyophilisation systems and filtration equipment required for the purification and drying of peptide APIs.

Analytical capabilities at the site include UPLC, HPLC, GC-MS and high-resolution mass spectrometry, as well as techniques used to study peptide structure and purity.

These systems are important because peptide APIs can generate complex impurity profiles during synthesis. Identifying and controlling those impurities is a central requirement before a product can be manufactured consistently at commercial scale.

Facility Designed for Global Regulatory Requirements

Neuland says the peptide manufacturing operation has been designed around global current Good Manufacturing Practice requirements, including standards expected by the US Food and Drug Administration, European Medicines Agency and Japan’s PMDA.

The facility incorporates segregated manufacturing suites, automated data systems and 21 CFR Part 11-compliant data-integrity controls.

Neuland already operates three US FDA-approved API manufacturing facilities with a combined API reactor capacity of approximately 1.174 million litres. The dedicated peptide plant adds a specialised manufacturing platform alongside that conventional API infrastructure.

Three Additional Modules Planned

The first 6,370-litre module is only the initial stage of the Bonthapally peptide expansion.

Neuland says three additional modules are planned as customer demand grows. The site has therefore been designed with space for substantially larger SPPS and LPPS reactors in later phases.

The company has also said that Module 1 had already secured approximately $30 million in firm commitments, indicating that part of the new capacity had customer programmes associated with it even before the wider expansion was completed.

Building India’s Position in Complex Pharmaceutical Manufacturing

The significance of the Bonthapally expansion lies in the type of manufacturing capability being created.

Peptide APIs occupy a more specialised segment of pharmaceutical manufacturing than conventional small-molecule bulk drugs. They require complex synthesis routes, sophisticated purification and strong analytical control, particularly when products move into commercial production.

By adding dedicated commercial-scale SPPS and LPPS capacity, Neuland is positioning itself to compete for a larger share of this specialised global contract-manufacturing market.

The new facility also adds to India’s broader movement from high-volume generic API production towards more complex pharmaceutical manufacturing, where process development, analytical capability and regulatory compliance carry greater value.

For Neuland, the 6,370-litre first module establishes a dedicated commercial base for peptide APIs while leaving room for substantially larger capacity as the market develops.

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