NEULAND LABS REPORTS ANOTHER SUCCESSFUL FDA AUDIT AND WINS 2015 CMO LEADERSHIP AWARD

NEULAND LABS REPORTS ANOTHER SUCCESSFUL FDA AUDIT AND WINS 2015 CMO LEADERSHIP AWARD

 —Recent FDA Audit is Neuland's Ninth Successful FDA Review; Matched by Record of Positive Regulatory Performance in Europe and Japan—

— 2015 CMO Leadership Award for Quality is Based on Independent Survey of Customers and Industry Experts—

Hyderabad, India – January 26, 2015 – Neuland Laboratories Ltd., (NSE:NEULANDLAB;  BSE-Scrip Code:524558), a pharmaceutical manufacturer providing active pharmaceutical ingredients (APIs), complex intermediates and custom manufacturing solutions services to customers located in 85 countries, today announced it has been awarded a 2015 CMO Leadership Award from Life Science Leader magazine in the Quality category. Neuland also announced that one of its two main manufacturing units successfully completed an audit by the U.S. Food and Drug Administration (FDA), replicating the success of the prior audit of this unit conducted in 2010. Neuland's other manufacturing unit completed a similarly problem-free FDA audit in 2012.

Neuland's Chief Executive Officer, Mr. Sucheth R. Davuluri, noted, "In our 30 years of operations, achieving the highest standards of quality and regulatory excellence have been core values for Neuland. We were proud to have been one of the first contract manufacturing companies in India to be inspected by the FDA in 1997, and today more than 90% of our business is in highly regulated markets in the U.S., Europe and Japan. Since we view quality and regulatory performance as deeply intertwined, it is fitting that we now have won CMO leadership awards in both categories. The entire Neuland organization is committed to ensuring that our worldwide reputation for quality and regulatory excellence is further strengthened and extended as we continue to grow in the coming years."

Neuland provides products and services to customers in 85 countries, focusing on the U.S., Europe and Japan. It is inspected and certified by the most rigorous regulatory agencies in the world.

The CMO Leadership Awards are based on responses of 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 most highly rated by industry respondents. Neuland will be included in the annual CMO Leadership Awards supplement that will be published in March 2015. The 2015 CMO Leadership Awards will be formally presented at a ceremony at the W Hotel in New York City on March 18, 2015.

About Neuland Labs                                                                                                                                    For 30 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 48 U.S. drug master files (DMFs) and a total of more than 400 DMFs in the European Union (EU) and other countries. Its manufacturing facilities are inspected and approved by the U.S. FDA and other leading regulatory agencies. Its record of quality manufacturing and reliability is highlighted by cGMP certifications that include the U.S. FDA, TGA (Australia), EDQM (EU), German Health Authority, Anvisa (Brazil), EMA (EU), Cofepris (Mexico), KFDA (Korea), PMDA (Japan), ISO 9001, ISO14001, OHSAS18001 and ISO 27001. For more information, visit www.NeulandLabs.com.

 

 

Suggested Articles

Drugmakers have voluntarily recalled their generic Zantac from the U.S. market after the FDA raised concerns, but it has not been without a cost.

Just weeks after selling the sterile manufacturing assets of its Kyowa operation in Japan, it has unloaded the rest of its Kyowa drugmaking operation.

India’s Aurobindo, which has yet to close its $1 billion deal to buy 300 Sandoz products in the U.S., continues to rack up FDA issues.