Immacule Lifesciences Private 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
- Village Thanthewal, Ropar Road, Nalagarh, Solan, Himachal Pradesh 174101, India (IND)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 3014210753 · DUNS 650694503
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 17 drugs. 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 Assurance2025-09-18
- VAIDrug Quality Assurance2023-03-14
- VAIDrug Quality Assurance2022-06-20
Drugs this plant is listed as making
17 distinct drugs across 27 products name this site in their FDA label.
- AcetylcysteineGlenmark Pharmaceuticals Inc., USA
- AcyclovirFresenius Kabi USA, LLC
- AlcoholBreckenridge Pharmaceutical Inc
- BaclofenAdvagen Pharma Limited
- Calcitonin SalmonCipla USA Inc.
- Chlorothiazide SodiumSun Pharmaceutical Industries, Inc.
- Chlorpromazine HydrochlorideFresenius Kabi USA, LLC
- Chromic ChlorideArchis Pharma LLC
- Cupric ChlorideRenova Pharmaceuticals LLC
- Hydralazine HydrochlorideBaxter Healthcare Corporation
- Hydrocortisone sodium succinateCipla USA Inc.
- micafunginBiocon Pharma Inc.
- Norepinephrine BitartrateBiocon Pharma Inc.
- pentamidine isethionateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- PhytonadioneCipla USA Inc.
- Tranexamic AcidProvepharm 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.