Preferred and Reliable API Supplier in the pharmaceutical industry
Neuland is a dedicated 100% API provider
that guarantees not to compete within finished products
Manufacturing Capabilities
3 USFDA Approved cGMP Manufacturing facilities with a total reactor volume of 907,000 liters.
Quality as a focus
Successfully inspected by USFDA (15 times, 2 PAIs), EMA, PMDA, Rx-360, TGA, KFDA, ANVISA, WHO.
Filing Support
Supported 3 NDA filings and 8 IND filings by supplying APIs and CMC documentation.
Tech Transfer
Agile tech transfer at all stages of drug lifecycle or for scale-up.
Regulatory Filings
Filed 916+ DMFs worldwide, with 62 DMFs with USFDA.
Global Clients
Export to more than 80 countries, with 80+ active clients.
Manufacturing Facilities Overview
UNIT-1Bonthapally, |
UNIT-2Pashamylaram, |
UNIT-3Gaddapotharam, |
|
|---|---|---|---|
| Year of Establishment | 1986 | 1994 | 2017 |
| Blocks | Block - 1, 2, 3, 4, H, KL & S | 34 Block-1, 2, 3, FC, NMSM, Mini plant6 | Block - 1, 2, 4, 5 |
| Hydrogenation Reaction Volume | 7.4KL | 6KL | Facility creation under process |
| Solvent Recovery System | 100KL/D | 20KL/D | 50KL/D |
| Cryogenic Reaction Volume | 25KL | 15KL | 15KL |
| Regulatory | USFDA, EDQM, CFDA, PMDA, et. al | USFDA, EDQM, PMDA, ANVISA et. al | Desktop Inspection by USFDA in 2020; ANVISA (Brazil) 2022 |
Regulatory Support
Neuland has a stellar history of successful regulatory inspections by leading regulatory authorities worldwide.
All our manufacturing sites and the R&D center are routinely inspected by global regulatory authorities to ensure our facilities, processes and products meet the strict cGMP standards.
R&D Capabilities Built
FBRM
Particle size check for polymorph achievement
Peptide lab
9800 sq. ft. new lab with additional 7 hoods for 25 chemists
Poly Block Reactors
For solubility/ crystallisation study, carrying out multiple reactions
Laboratory Reactors
Enhanced ability to perform reactions in a wide range of -90 to 200℃
Hazardous & Wet Laboratory
Dedicated area for hazardous chemical management and wet lab expansion
ID Laboratory, Unit-III
To address product quality issues, impurities synthesis, cost reduction
PID Laboratory, B-S, Unit-I
Expansion with 3 fume hoods along with space for 2 more laboratories.
Heating & Cooling Systems
For DoE studies and projects
About Neuland Laboratories
Established in 1984, Neuland Laboratories is an end-to-end solutions provider for the pharmaceutical industry’s chemistry needs as a leading manufacturer of active pharmaceutical ingredients (APIs). Supported by three world-class US FDA and EU GMP compliant manufacturing facilities and complex chemistry capabilities, Neuland has become a trusted partner for innovators as well as generics.
Our Custom Manufacturing Solutions span the full range of the pharmaceutical industry’s chemistry requirements, from pre-IND through commercial manufacturing.
We offer both small-scale clinical trial quantities and full commercial-scale supply with minimal tech transfer timelines. Our R&D facility is approved by the Department of Scientific and Industrial Research and inspected by the USFDA without any observations. The facility houses development labs, analytical labs, a kilo lab for scale-up and dedicated lab for peptides.
The company is headquartered in Hyderabad, India and the manufacturing and research facilities are situated near Hyderabad. Neuland is reliable manufacturing and development partner to customers in over 80 countries across US, Europe, Japan, APAC, India, MENA and LATAM.