Hitting a milestone such as 30 years old as a pharmaceutical manufacturing company is a pretty big deal. Pharma – as you can imagine – has changed. A lot.
Thirty years ago saw the world’s very first “blockbuster” drug (Tagamet). At the time, bringing a drug to market took (on average) about 12 years and $200 million. Amgen and Genentech were atypical examples of the otherwise unobtrusive, under-the-radar biotech sector. Big names – long-since forgotten across various mergers and roll-ups, included: Rhone-Poulenc, Glaxo Labs, Bristol-Meyers, Warner-Lambert, Wyeth.
Thirty years is also a great time to take stock, pay homage to our heritage and continue to expand our position as a leader in process chemistry & regulatory excellence. Anniversaries like this one are fun, and it’s really exciting for us to take in how far we’ve come across those three decades.
Here’s an informal snapshot of today’s Neuland Labs:
- Neuland has a presence in over 85 countries around the world
- 80% of our revenues are derived from exports, with the U.S. and Europe being our two largest markets
Over 700 customers worldwide, ranging from early stage through leading Fortune 500 Pharma companies.
Our Core Strength:
Partnering with companies throughout the product life cycle and bringing our strong process chemistry, manufacturing, and regulatory excellence to each project.
Our Core Business:
Manufacturing of API’s and advanced intermediates. We provide end-to-end chemistry services for the pharmaceutical industry – from the synthesis of library compounds, to NCE supply, to clinical intermediate production, to commercial manufacture and supply.
Our Top Products:
- Ciprofloxacin HCl
- Ranitidine HCl
- Enalapril Maleate
- Sotalol HCl
- Ipratropium Bromidet
Our Top Therapeutic Areas:
Cardiovascular, central nervous system, anti-invectives, anti-asthmatics, anti-fungals, anti-ulcerants and anti-spasmodics
- 2 US FDA, EDQM inspected manufacturing facilities
- Seven production blocks covering 2,800 to 4,500 sq. meters of production area
- Mini-plant for new product scale-up
- Total reactor volume of up to 375,000 liters
- 40,000 sq. ft. state-of-the-art R&D facility in Hyderabad, India
Our Regulatory Track Record:
- 45 DMFs filed with the US FDA
- Over 400 DMFs filed with various health authorities in Europe, Canada, Japan, Korea and Australia.
- Facilities are inspected (and/or certified) by the FDA, TGA, EDQM, German Health Authority, ANVISA, ISO 14001, ISO 27001 and OHSAS 18001.
- In both 2013 and 2014, Neuland received the CMO Leadership Award for Regulatory Excellence.
Neuland has over 1000 employees, including approximately 200 scientists working in R & D, with 31 Ph.Ds.