Neuland Laboratories is a leading global API contract development and manufacturing organization (CDMO). It supports biotechnology and pharmaceutical companies in the design, development and manufacturing of complex active pharmaceutical ingredients (APIs). It develops small molecules and peptides for clinical trials and beyond, with the capacity to scale-up through every stage of the product lifecycle to commercial manufacturing.

The company is headquartered in Hyderabad, India and operates as a pure-play API manufacturing service provider. Neuland offers a wide range of customised chemistry solutions designed to meet the evolving requirements of the global pharmaceutical industry. Over the past years, the company has evolved significantly through its work on new chemical entities (NCEs) with numerous venture-backed biotech firms as well as recent engagements with Big Pharma.

The company has established itself as a trusted API-preferred partner with significant expertise in complex chemistry. Neuland provides a comprehensive suite of services, including custom synthesis and the supply of advanced intermediates and APIs across multiple stages of clinical development. It also offers Chemistry, Manufacturing, and Controls (CMC) support for New Drug Application (NDA) filings and manufacturing support throughout the commercial product lifecycle, from product launch and lifecycle management to eventual genericisation.

Business area of the company

The company is engaged in manufacturing and selling of bulk drugs and caters to both domestic and international markets.

Business verticals

• Generic drug substances (GDS): Manufacturing of generic, non-exclusive complex APIs.
• Custom manufacturing solutions (CMS): Contract development and manufacturing of NCE APIs and advanced intermediates for innovators.

Milestones

• 1984: Incorporated
• 1986: First API sale of Salbutamol Sulphate/ Albuterol Sulphate
• 1994: Neuland goes public
• 1997: First USFDA audit
• 2004: US operations commenced
• 2007: Subsidiary established in Japan
• 2008: R&D centre established, EDQM audit of Unit-I
• 2009: First NCE approval from PMDA, Japan
• 2013: Strategic alignment towards niche APIs and Custom Manufacturing Solutions
• 2016: R&D facility approved by USFDA
• 2017: Among the first three API facilities in India audited by CFDA (Unit I)
• 2017: EDQM audit of Unit I
• 2018: Acquisition of advanced intermediates and API facility
• 2019: Increased CMS project inflow from Japan
• 2019: Emphasis on supply chain de-risking
• 2020: USFDA audit of Unit II
• 2021: Unit III commercialised with 320 kL reaction volume
• 2023: Revenue crossed Rs 1,000 crore
• 2023: USFDA audit of Unit III
• 2023: EDQM audit of Unit I
• 2024: USFDA audit of Unit I
• 2025: USFDA audit of Unit II
• 2025: Groundbreaking of a new peptide facility