Sun Pharma receives Warning Letter for Halol facility

Sun Pharmaceutical Industries Ltd announced that it has received a Warning Letter from the US FDA as a result of the September 2014 inspection, for its facility located at Halol, Gujarat in India.

Sun Pharma responded to the US FDA inspection observations with a robust remediation process that is
still on-going, with significant investments in automation and training to enhance its Quality Systems. Sun
Pharma has been working with external consultants to ensure its remediation activities have been
completed in an appropriate manner.

Since the inspection in September 2014, Sun Pharma has communicated regularly with the US FDA on
the progress of its remediation and on issues of product supply. It has provided periodic updates to the
US FDA on its commitments. Post the September 2014 inspection, the US FDA has withheld future
product approvals from the Halol facility. This situation may continue until all issues are resolved. Sun
Pharma expects to request a re-inspection by US FDA upon completion of its remediation commitments.
Sun Pharma and the Halol facility will continue to supply important drug products to meet its obligations
to its customers and the patients who use its drugs in the United States and around the world.

Sun Pharma will respond to this Warning Letter with a detailed plan within the stipulated time frame.

Sun Pharma in Collaboration With Weizmann Institute

Sun Pharmaceutical Industries Ltd has entered into a tripartite research and option agreement with Israel-based Weizmann Institute of Science and Spain’s Health Research Institute of Santiago de Compostela (IDIS) to develop breakthrough products for the treatment of neurological diseases like brain stroke; as well as glioblastoma, a lethal brain cancer. Scientists at Weizmann Institute have developed a recombinant enzyme currently undergoing animal studies for indications of brain stroke and glioblastoma. Further studies of this enzyme will be conducted at the Health Research Institute of Santiago de Compostela in Spain. Moreover, this enzyme may potentially be indicated for uses beyond these two brain diseases. 

As per the signed triparty agreement, Sun Pharma will have the first right to develop these additional indications. Sun Pharma will have the exclusive option to conduct further development of the enzyme after completion of the preclinical studies. The company will have commercial rights to this product globally. It will also fund all future studies to be conducted on the enzyme. The tripartite research collaboration agreement has been signed between Sun Pharma, Yeda Research & Development Company, Ltd. (the commercial arm of the Weizmann Institute of Science), and Fundacion Ramón Domínguez (on behalf of IDIS). Based on outcome of animal studies, Sun Pharma will have an option to exercise rights for further development and commercialization of the enzyme.  

SUN PHARMA COMPLETED Opiates Business Acquisition

Sun Pharmaceutical Industries Ltd begins the integration of its Opiates business in Australia following the successful completion of this acquisition from GKS. This acquisition fortifies Sun Pharma's global position with two Opiates manufacturing facilities in Port Fairy and Latrobe complementing its current API manufacturing footprint globally.

Sun Pharma now offers a rich basket of Opiates product line in addition to a large API portfolio and dosage formulations covering a broad range chronic and acute prescription drugs. The acquisition also brings a specialized team to drive business growth.

The Opiates acquisition allow Sun Pharma to:

• Significantly expands its narcotic raw material market share
• Enhance Opiate Alkaloids portfolio and depth in Global opiates market
• Strengthen its strategic position in the global opiates business