Frequently Asked Questions About Nodict (Naltrexone Hydrochloride) for Alcohol Treatment

• DCGI (India) - Drug Controller General of India; regulatory body for Nodict manufacture and Sun Pharma operations
• U.S. FDA - Naltrexone approved 1984 (oral); Sun Pharma operates FDA-inspected facilities
• European Medicines Agency (EMA) - Naltrexone widely approved across EU member states
• WHO Essential Medicines List - Includes naltrexone for substance use disorder treatment
• UK MHRA, Health Canada, Australia TGA - All recognise naltrexone and Sun Pharma quality standards
• Sun Pharma manufacturing - WHO-GMP certified; US-FDA, EU-EMA, UK-MHRA inspected facilities globally

• APA Practice Guideline for AUD - American Psychiatric Association practice standards
• NIAAA pharmacotherapy guidance - U.S. National Institute on Alcohol Abuse and Alcoholism
• SAMHSA Treatment Improvement Protocols - U.S. federal addiction treatment standards
• ASAM National Practice Guideline - American Society of Addiction Medicine
• WHO substance use treatment framework - Global treatment standards
• European Federation of Addiction Societies - EU-wide guidelines
• Indian Psychiatric Society addiction guidelines - Indian clinical practice standards

• NIAAA COMBINE Study (2006) - Landmark trial confirming naltrexone efficacy in AUD
• Cochrane systematic reviews - Multiple meta-analyses of naltrexone for AUD and OUD
• Sinclair Method evidence base - Targeted naltrexone for drinking reduction
• VIVITROL development trials - Extended-release injection efficacy data
• UpToDate, DynaMed - Clinical decision support databases
• LactMed lactation safety database - Pregnancy and breastfeeding safety information
• FDA FAERS and EMA EudraVigilance - Post-marketing safety surveillance

Sun Pharma bioequivalence studies establish therapeutic equivalence of Nodict with reference naltrexone products.

Former NIAAA Division Director and one of the leading public-health voices on AUD treatment in the United States. Long career in clinical and translational research on AUD pharmacotherapy including naltrexone. Founded Alltyr Clinic providing modern evidence-based AUD treatment.

Professor of Psychiatry and Director of Treatment Research at the Center for Studies of Addiction at Penn. Decades of NIH-funded clinical research on naltrexone and combination pharmacotherapy for AUD. Author of more than 200 peer-reviewed publications.

Professor and former Director of the Department of Addictive Behavior and Addiction Medicine. Leading European AUD pharmacotherapy researcher. Principal investigator on multiple major trials of AUD medications including naltrexone and nalmefene.

Professor of Psychiatry and Behavioral Sciences; Director of the Center for Substance Abuse Treatment and Research at Johns Hopkins. Internationally recognised researcher on opioid pharmacology including naltrexone, buprenorphine, and methadone. Frequent FDA and NIDA advisor.

Professor of Psychiatry at Columbia and addiction psychiatry researcher with major contributions to pharmacotherapy for substance use disorders. Past President of the American Academy of Addiction Psychiatry. Active researcher on naltrexone and combination treatments.