28191113107112 F. No. CT/83/12-DCG (I) Directorate General of Health Services Office of Drues Controller General (Indial (New Drug Divisionl FDA Bhawan New Delhi Dated: 3l_i. -f { To M/s. Klinera Corporation India, 40 1, Hill View Indl. Estate, Amrut Nagar, L.B.S. Marg, Ghatkopar (W), Mumbai-4OO 086. Subiect: Clinical trial with Ranolazine 500 mg film coated tablets (Protocol No: GS-US-259- 0 147 dated 19-Mar-20 1 2)-regarding. CT No: CT/Drugs/ 75612012 Reference: Your letter no nil dated 1I l07 I 12. Sir, Permission is hereby granted to you under the provisions of Rule 122 DA of Drugs and Cosmetics Rules to conduct Phase III clinibal trial with the said drug at the sites and under the supervision of the investigators as mentioned below and as per the protocol forwarded to this Directorate. 1. Dr. Badgandi Mohan Manipal Hospital, Airport Road, Bangalore' 2. Dr. Mala Darmalingam Endocrinolog' & Diabetes Research Centre, Bangalore, Malleshwaram, Karnataka. 3. Dr. Abhay Mutha, Diabetes Care and Research Centre, Pune. 4. Dr. Ramanathan Balamurgan, Kovai Diabetes Speciality Centre & Hospital, Ramnagar, Coimbatore. 5. Dr. Chittaranjan S Yajnik, KEM Hospital, Rastha Peth, Pune. 6. Dr. Kiran Pal Singh, Fortis Hospital, Mohali, Fortis City Center, Punjab. 7. Dr. Sivagnanam Nallaperumal, Swamy Diabetes Centre, R.K. Mutt Road, Mandaveli, Chennai. 8. Dr. K. M. Prasanna, The Bangalore Diabetes Hospital, 16lM, Thimmainah Road, Vasanthnagar, Bangalore. g. Dr. Sanjeev Ratnakar Phatak, DHL Research Centre, 2nd Floor, Ahmedabad. 10. Dr. Darshan Banker, Banker's Heart Institute, Vadodara. 11. Dr" Bansi Saboo, Dia Care- A Complete Diabetes Care Center, 1 & 2, Gandhi Park, Near Nehrunagar Cross Roadsn Ambawadi, Ahmedabad. 12.Dr. Rakesh Kumar Sahay, Osmania General Hospital, Afzalgunj, Hyderabad' 13. Dr" S. Srikanta, Jnana Sanjeevani Medical Center, J.P. Nagar Bangalore" 14. Dr. Ardhanareeshwaran Sharda, Endocrinolory Diabetes Centre, 640, 1st stage Indiranagar Karnataka, Bangalore-560078. 15. Dr, eshGh Saxena, Diabetes and Heart Centre, Main Sunder Nagar Road, Ludhiana 16. Dr. Padmalatha Devi, Diabetomics India, Banjara Hills, Hyderabad. 17.Dr. Hansraj Alva, Vinaya Hospital and Research Centre, Karangalpady, Mangalore, 18. Dr. Sanjay Reddy, Bangalore Diabetes Hospital, Bangalore, Karnataka. 19. Dr. Subhankar Choudhury, IPGME & It and SSKM Hospital, Kolkatta. 20. Dr. Jayashri Shembatkar, Getwell Hospital and Research Institute, Nagpur- 440012. 2l.Dr. Sunil Ambulkar, Institue of Clinical Endocrinolory (I.C.E) and Diabetes Care ' Unit (D.C.U), NagPur. 22.Dr. Tushar Bandgar, Seth G.S. Medical college and KEM Hospital, Mumbai Department of Endocrinolory, Mumbai. \ i i l I