Neuland Track Record of cGMP Excellence Complemented by 2013 CMO Leadership Award for Regulatory Excellence
Published: Oct 16, 2013
HYDERABAD, India, Oct. 16, 2013 /PRNewswire/ -- Neuland Laboratories Ltd., (NSE:NEULANDLAB; BOM:524558) a pharmaceutical manufacturer providing active pharmaceutical ingredients (APIs), complex intermediates and contract manufacturing services to customers located in 85 countries, today announced it has been awarded a 2013 CMO Leadership Award from Life Science Leader magazine in the Regulatory category, which complements the company's long track record of current Good Manufacturing Practices (cGMP) excellence.
In accepting the 2013 award, Neuland's Chief Executive Officer, Mr. Sucheth R. Davuluri, noted, "Creating a quality-conscious organization has been a goal from our founding days, and we are proud that in our almost 30 years as an API and contract pharmaceutical manufacturer, we have compiled a consistent track record of cGMP excellence. We are honored that our strengths in regulatory reporting and processing have been recognized with a CMO Leadership Award from our customers and other industry leaders, as we strive to extend this record of comprehensive regulatory excellence."
Neuland provides products and services to customers in 85 countries, focusing on the US, Europe and Japan. It is inspected and certified by the most rigorous regulatory agencies in the world. Consistent with its record of cGMP excellence, Neuland's last two FDA inspections had no Form 483 citations issued. Form 483 is used by FDA investigators to record observations of non-compliance with the FDA's cGMP standards. In 2010 alone, the FDA issued almost 10,000 Form 483 warnings.
Mr. Davuluri continued, "We intend to continue the high level of vigilance and oversight in every aspect of our operations that has enabled us to maintain this consistent record of quality and reliability, and we want to acknowledge the exceptional team at Neuland who made this award possible, with their ongoing daily commitment to quality in everything that we do."
The CMO Leadership Awards are based on responses of more than 10,000 pharmaceutical and biopharmaceutical executives to a survey conducted by Nice Insight and sponsored by Life Science Leader magazine. The award recognizes those contract manufacturing organizations that are the most highly rated by industry respondents. The survey covered more than 100 CMOs.
Neuland Labs will be recognized as an award winner in the annual CMO Leadership Awards supplement that will be published by Life Science Leader in October, 2013. The 2013 CMO Leadership Awards will be formally presented at a ceremony in New York City on March 12, 2014.
To learn more about how Neuland can support your contract manufacturing, peptide manufacturing and API production needs, visit Booth # 30B32 at the 2013 CPhI Worldwide Conference being held October 22-24, 2013 in Frankfurt, Germany.
Neuland Laboratories is listed on India's National Stock Exchange under the symbol NEULANDLAB and on the Bombay Stock Exchange under code 524558 and the symbol Neuland.EO.
About Neuland Labs
For over 25 years, Neuland Labs has been at the forefront of manufacturing APIs through its cGMP manufacturing facilities, working with customers in 85 countries. Neuland Labs has developed more than 300 processes and 60 APIs, and it has filed more than 45 US drug master files (DMFs), 14 EU CEPs and a total of more than 400 DMFs worldwide. Its manufacturing facilities are inspected and approved by the US FDA and other leading regulatory agencies. Its record of quality manufacturing and reliability is highlighted by cGMP certifications that include the FDA, TGA, EDQM, German Health Authority, ISO 14001, ISO 27001 and OHSAS 18001. For more information, visit www.NeulandLabs.com.
Neuland Laboratories Ltd.
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SOURCE Neuland Laboratories Ltd.
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