Neuland Labs has been supporting innovator Pharma and Biotech companies in custom small molecule API development and manufacturing for over two decades. Three USFDA and cGMP compliant manufacturing facilities, state-of-the-art R&D center, experience in complex chemical processes help handle a range of chemistry services from pre-IND through commercial manufacturing. We offer both smallscale clinical trial quantities and full commercial-scale supply with minimal tech transfer timelines.
We provide custom NCE API development and
manufacturing services from lab to commercial supply
Manufacture of Deuterated molecules, Cyanation, Hydrogenation, Bromination, Chiral molecules manufacture
Cryogenic reactions, Cholic acid and Chenodeoxycholic acid, Enzymatic reactions, Synthetic portion of fermented molecules, Micronization (D90 <5 micron) Development
15 Years of experience in solid and liquid phase synthesis of Peptides under cGMP
Up to 35 AA scaled-up to tens of KG (24 steps of chemistry) for innovator companies (US / EU / Japan)
3 USFDA Approved cGMP Manufacturing facilities with a total reactor volume of 907,000 liters.
Successfully inspected by USFDA (15 times, 2 PA, EMA, PNDA, Rx 360, TGA, KFDA, ANVISA, WHO.
Supported 3 NDA filings and 8 IND filings by supplying APIs and CMC documentation.
Agile tech trader at all stages of drug lifecycle or for scale-up.
Filed 916+ DMFs worldwide, with 62 DMs with US FDA.
Export to more than 80 countries, with 80 active clients.
Particle size check for
polymorph achievement
9800sq.ft. new lab with
additional 7 hoods for 25
chemists
For solubility / crystallisation
study, carrying out multiple
reactions
Enhanced ability to perform
reactions in a wide range of -90 to
200oC
Dedicated area for hazardous chemical management and wet lab expansion
To address product quality issues, impurities synthesis, cost reduction
Expansion with 3 fume hoods along with space for 2 more laboratories.
For DoE studies and projects
Particle size check for
polymorph achievement
9800sq.ft. new lab with
additional 7 hoods for 25
chemists
For solubility / crystallisation
study, carrying out multiple
reactions
Enhanced ability to perform
reactions in a wide range of -90 to
200oC
Dedicated area for hazardous chemical management and wet lab expansion
To address product quality issues, impurities synthesis, cost reduction
Expansion with 3 fume hoods along with space for 2 more laboratories.
For DoE studies and projects
Neuland Labs has been supporting innovator Pharma and Biotech companies in custom small molecule API development and manufacturing for over two decades
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A US based clinical-stage Biotech company specializing in CNS treatments partnered with Neuland for the development of a NCE API.
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Neuland works to understand our manufacturing process improvements. The team appears to carefully consider alternatives and implement optimizations.
Excellent at troubleshooting and working through process issues
Very communicative and responsive, shows high flexibility to changes during R&D phase.