Lupin Ltd and Natco Pharma announced on Thursday to jointly commercialise generic equivalent of Glaxo's Tykerb (Lapatinib ditosylate) tablets. Natco had filed an abbreviated new drug application (ANDA) seeking US FDA's approval for marketing generic equivalent of Tykerb 250 mg tablets.
Natco and Lupin believe that they are first-to-file an ANDA containing a paragraph IV certification for Lapatinib. Tykerb had sales of $ 113.6 million as of March (IMS).
Most of the conditions were already complied with, and the same is being communicated to APPCB immediately. However, the company is having six more manufacturing facilities in addition to the above said unit and all are operating without any impediments. The company is taking all possible steps to revoke the orders shortly.
REpower Systems SE , in which Suzlon Energy Ltd holds nearly 95 per cent shareholding, and Alerion CleanPower SpA, an Italy-based renewable energy company, have signed a contract for a 44-MW wind energy project in Italy. REpower is responsible for supplying and commissioning the turbines and the Italy-based subsidiary of REpower would start construction in fall 2011.
Referring to media reports regarding attachment of properties, by the Directorate of Enforcement, of various entities named in the charge sheet filed by CBI, Unitech Ltd has clarified that it has not been named in the aforesaid charge sheet filed by the CBI and the on-going matter pertains to Unitech Wireless (Tamil Nadu) Pvt Ltd (Uninor), which is a separate legal entity engaged in the telecom business. The company reiterated that Unitech Ltd would continue to focus on its real estate business in normal course.