Established in 1984, Neuland Laboratories Limited is a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry’s chemistry needs. Supported by our world-class manufacturing facilities and complex chemistry capabilities, we have become a trusted generic and new chemical entity (NCE) API manufacturing partner and supplier to some of the biggest names in global pharmaceutical industry. Our solutions span the full range of the pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life-cycle, as well as commercial launch. The Company is headquartered in Hyderabad, India while our manufacturing and research facilities are situated near Hyderabad. Business development offices have been set up in the US and Japan to strengthen our global collaborations.
We have three world-class API manufacturing facilities capable of handling complex and hazardous reactions. The manufacturing facilities comply with all regulatory guidelines and requirements of current Good Manufacturing Practices (cGMP) and have been successfully inspected/approved by international health and regulatory agencies. Our facilities (Unit I and II) have successfully cleared 15 US FDA audits, a testimony to the reliability of our systems and processes. For the recently commissioned Unit-III, we are working with the US FDA to expedite the inspection and the approval for commercial manufacturing of APIs.
We have a dedicated state-of-the-art R&D facility which has been approved by the Department of Scientific and Industrial Research (DSIR) and inspected by the US FDA in February 2016 without any observations. The facility houses development laboratories, analytical laboratories, a dedicated kilo laboratory for scale-up and a dedicated laboratory for peptides. Our R&D facility has proven its capabilities in carrying out a wide range of reactions, including bringing complex molecules with efficient processes to market; developing non-infringing processes; developing cost-effective routes; reducing impurities levels by better process understanding; and reducing effluent generation.
European Medical Agency (EMA)
B farm (German Health)
Russia (The Ministry of Health of the Russian Federation)
ISO 9001, ISO 14001, ISO 45001 and ISO 27001
We have two main business verticals: Generic Drug Substances (GDS) and Custom Manufacturing Solutions (CMS). While we primarily have these two businesses, the expertise within them extends to both small molecules as well as peptides.
Stable balance sheet with low debt
Presence in over 85 countries
Customer support across the product lifecycle
Long-standing relationships with leading generic and innovator companies
Proven track record of regulatory adherence across geographies
Quality products with high technological complexities
Three cGMP compliant manufacturing facilities
Manufacturing APIs for over 35 years
High-end complex chemistry capabilities
US FDA inspected R&D centre
years of experience
APIs scaled up across 10 therapeutic categories
Drug Master Files (DMFs) worldwide
active US DMFs
API manufacturing capacity
of revenue from exports
R&D employees approximately 300
Note: % refers to FY 2021 sales by end market