Sun Pharmaceutical Industries Limited
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- India
- Registered address
- Halol-Baroda Highway, Halol, Gujarat 389350, India (IND)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3002809586 · DUNS 725959238
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 43 drugs, 3 already in shortage. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2025-06-13
- OAIDrug Quality Assurance2022-05-09
- OAIDrug Quality Assurance2019-12-13
- NAIDrug Quality Assurance2019-06-11
- NAIDrug Quality Assurance2018-12-06
- NAIDrug Quality Assurance2018-08-31
- VAIDrug Quality Assurance2018-02-23
- OAIDrug Quality Assurance2016-12-01
- OAIDrug Quality Assurance2014-09-16
- VAIDrug Quality Assurance2012-09-28
- VAIDrug Quality Assurance2012-06-13
- NAIDrug Quality Assurance2011-04-07
Drugs this plant is listed as making
43 distinct drugs across 107 products name this site in their FDA label.
- Alfuzosin HydrochlorideSun Pharmaceutical Industries, Inc.
- Azelastine HydrochlorideSun Pharmaceutical Industries, Inc.
- AzithromycinSun Pharmaceutical Industries, Inc.
- Bupropion hydrochlorideSun Pharmaceutical Industries, Inc.
- Caffeine CitrateSun Pharmaceutical Industries, Inc.
- CalcitriolSun Pharmaceutical Industries, Inc.
- CapecitabineSun Pharmaceutical Industries, Inc.
- Carbidopa And LevodopaSun Pharmaceutical Industries, Inc.
- Chlorothiazide SodiumSun Pharmaceutical Industries, Inc.
- Clopidogrel BisulfateSun Pharmaceutical Industries, Inc.
- decitabineSun Pharmaceutical Industries, Inc.
- Desmopressin Acetatein shortageSun Pharmaceutical Industries, Inc.
- Diltiazem HydrochlorideSun Pharmaceutical Industries, Inc.
- Divalproex SodiumSun Pharmaceutical Industries, Inc.
- DocetaxelSun Pharmaceutical Industries, Inc.
- Doxorubicin HydrochlorideBluePoint Laboratories
- DuloxetineSun Pharmaceutical Industries, Inc.
- ErlotinibSun Pharmaceutical Industries, Inc.
- FingolimodSun Pharmaceutical Industries, Inc.
- Ibandronate SodiumSun Pharmaceutical Industries, Inc.
- imatinib mesylateBluePoint Laboratories
- Ketorolac Tromethaminein shortageSun Pharmaceutical Industries, Inc.
- latanoprostSun Pharmaceutical Industries, Inc.
- leuprolide acetateSun Pharmaceutical Industries, Inc.
- Medroxyprogesterone AcetateSun Pharmaceutical Industries, Inc.
- ondansetronSun Pharmaceutical Industries, Inc.
- ondansetron hydrochlorideSun Pharmaceutical Industries, Inc.
- OxcarbazepineSun Pharmaceutical Industries, Inc.
- Pantoprazole SodiumSun Pharmaceutical Industries, Inc.
- phenytoin sodiumSun Pharmaceutical Industries, Inc.
- Riluzolein shortageSun Pharmaceutical Industries, Inc.
- Rivastigmine TartrateSun Pharmaceutical Industries, Inc.
- Sumatriptan SuccinateSun Pharmaceutical Industries, Inc.
- Tamsulosin HydrochlorideSun Pharmaceutical Industries, Inc.
- TemozolomideSun Pharmaceutical Industries, Inc.
- Testosterone CypionateSun Pharmaceutical Industries, Inc.
- Tiagabine HydrochlorideSun Pharmaceutical Industries, Inc.
- Tramadol HydrochlorideSun Pharmaceutical Industries, Inc.
- Venlafaxine HydrochlorideSun Pharmaceutical Industries, Inc.
- ZonisamideSun Pharmaceutical Industries, Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.