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Company Overview

Neuland Laboratories Limited was established in 1984 and today is a publicly listed company headquartered in Hyderabad, India. Neuland is a leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry’s chemistry needs.

We provide solutions across 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. Our strength is our expertise in manufacturing of APIs and advanced intermediates from our US FDA approved facilities. Our core competency lies in the application of strong process chemistry to manufacturing in a regulatory compliant environment, which is supported by a strong, well-qualified team of more than 1400 employees.

For over three decades, Neuland has been at the forefront of facilitating and accelerating drug development and cGMP manufacturing of APIs. The Company’s technical and scientific teams provide comprehensive solutions and services to the global pharmaceutical industry.

 Neuland Company-Overview

Key Points

  • Quality, EHS and compliance is at the heart of Neuland and across our facilities, with a track record of regulatory approvals (15 successful US FDA inspections)
  • Focusing on our API capabilities and providing services such as cost-effective synthesis, IP protection and regulatory expertise we strive to meet all of our customers’ API needs
  • Helping customers across the full spectrum of the product lifecycle, from preclinical all the way to generic, with over 75 APIs scaled up
  • A dedicated state-of-the-art 3,400m2 R&D centre, located near Hyderabad, with around 300 scientists
  • Two world-class manufacturing plants with 7 production blocks in Unit 1 and 6 production blocks in Unit 2, covering 2,800 to 4,500m2 of production area, and a mini-plant for scaling up of new products
  • Total reactor volume of around 860+ KL and capable of handling a broad range of reactions and wide choice of process parameters
  • USFDA, EDQM, EMA, PMDA, TGA, BfArM, AFSSAPS, ANVISA, COFEPRIS, KFDA, ISO 14001, ISO 27001 and OHSAS 18001 certified
  • Over 903+ DMFs worldwide and with a presence in over 85 countries
  • Quality, EHS and compliance is at the heart of Neuland and across our facilities, with a track record of regulatory approvals (15 successful US FDA inspections)
  • Reliability underpinned by transparency provided by ‘Neuland GuarD’, our unique project management system
  • Listed on the Bombay Stock Exchange (BSE) and National Stock Exchange (NSE)

Our Markets

Neuland has a presence in over 80 countries with more than 75% of our revenues accounted for by exports. The US and Europe are our key markets, accounting for 70% of total exports.

The Company has now filed 60 DMFs with the USFDA, over 490 DMFs in Europe, and many more with the various health authorities in Canada, Japan, Korea and Australia.

Regulatory Filings Feb 2022