PRINCETON, N.J., Dec. 1 /PRNewswire/ -- Ranbaxy Laboratories Limited (RLL) said today that if called upon by the U.S. Government or by the innovator, Roche Laboratories Inc., the Ranbaxy global organization is well prepared to provide oseltamivir phosphate capsules (generic version of Tamiflu(R)) to the U.S. healthcare system to meet the threat of the Avian flu, that has now become a global concern.
Dr. Brian Tempest, CEO and Managing Director of RLL, stated, “In terms of available capacity, within six months, we anticipate being able to produce 22 Tons per Annum (TPA) of the Active Pharmaceutical Ingredient (API) based on Ranbaxy’s API process. Within a twelve month period, we would expect to scale up our operations to produce a total of 100 TPA. The 22 TPA level translates to a total of approximately 300 million 75 mg capsules, and within a year to a total of 1.3 billion 75 mg capsules. The API would be manufactured in Ranbaxy’s FDA-compliant facilities in India, and the capsules could be manufactured at our U.S. facilities. It is estimated that within the first six months approximately 20 million patients could receive a course of treatment, and within the first year in excess of 100 million patients could be managed for the Avian flu.”
“The starting material (shikimic acid) is critical to the entire process, and all efforts will be made to secure the required quantities from a variety of independent sources. Ranbaxy will make all efforts to work with the U.S. FDA to secure approvals to manufacture the API as well as capsules within Ranbaxy facilities in order to reach the projected goals as may be indicated by the U.S. Government. We are prepared and are committed to meet the needs of the U.S. healthcare system, and are willing and able to partner with other organizations, including the innovator, to effectively meet this public health challenge that threatens the U.S.,” Dr. Tempest concluded.
Roche Laboratories Inc., the innovator, has in fact been in talks with Ranbaxy in recent weeks to explore various avenues for partnership between the two companies in order to meet the immediate and critical requirements of oseltamivir phosphate.
Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary “platform technologies”, resulting in a number of products under development. The Company is serving its customers in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 46 countries and manufacturing operations in 7 countries.
* Tamiflu(R) is a registered trademark of Roche Laboratories Inc.
Ranbaxy Laboratories Limited
CONTACT: Charles M. Caprariello, Vice President, Corporate Communications,Ranbaxy Inc., +1-609-720-5615; Edwige Buteau, +1-212-994-7517, or AnujBaveja, +1-212-994-7552, both of RF Binder Partners Inc.
Web site: http://www.ranbaxy.com/
