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This Disclosure Program is to provide a channel for those who wish to disclose to the CDRO any issues or questions associated with policies, conduct, practices, or procedures believed to be a potential violation of the U.S. Federal Food, Drug, and Cosmetic Act related to Legacy Ranbaxy Facilities. Legacy Ranbaxy Facilities include the following:
  1. Ohm Laboratories, 14 Terminal Road, New Brunswick, NJ.
  2. Ohm Laboratories, 1385 Livingston Ave. North Brunswick, NJ.
  3. Sun Pharmaceutical Industries Limited, Plot No. A-41, Industrial Area, SAS Nagar, Phase VIIIA, Mohali, Punjab, India.
  4. Sun Pharmaceutical Industries Limited, Research & Development Centre, and Clinical Pharmacology & Pharmacokinetics, Sarhaul, Sector 18 Udyog Vihar Industrial Area, Gurugram, Haryana, India.
  5. Sun Pharmaceutical Industries Limited, Ghirongi Industrial Area, Malanpur, Madhya Pradesh, India
  6. Sun Pharmaceutical Industries Limited, Clinical Pharmacology Unit, Hamdard Nagar, New Delhi, India.
  7. Terapia S.A, Clinical Pharmacology & Pharmacokinetics Department, 124 Fabricii Street, 400632 Cluj-Napoca Romania.

1. Is the issue/are the issues related to violations of ‘Good Manufacturing Practices’ at Legacy Ranbaxy manufacturing site engaged in manufacturing the Active Pharmaceutical drug(API) or Drug Products for US markets or US submissions? Yes No
2. Is the issue/are the issues related to untrue statement and/or pattern or practice of data irregularities at any Legacy Ranbaxy manufacturing site or clinical labs for US markets or US submissions? Yes No
3. Is the issue/are the issues being reported highlighting any adulteration of API or Drug Product manufactured at a Legacy Ranbaxy Facility currently manufacturing the products for the US Market or US submissions? Yes No
4. Does the issue(s) being reported concern the ‘Stability Program’ of any API or Drug Product manufactured at a Legacy Ranbaxy Facility for the US market or US submissions? Yes No
5. Is the issues/are the issues related to ‘Bioequivalence Studies’ conducted at a Legacy Ranbaxy facility for products intended to be marketed for the U.S. market or for U.S. submissions? Yes No
6. Do you have data to support the Disclosure? Yes No
7. Is this an employee ‘Code of Conduct’ issue? Yes No
8. Is this disclosure related to personal grievances or other HR issues? Yes No