Drug factory · FDA FEI 3014210753

Immacule Lifesciences Private Limited

Village Thanthewal, Ropar Road, Nalagarh, Solan, India

Serious problems, FDA action at FDA's last inspection, Sep 18, 2025.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

3 drug inspections on record since 2022: 0 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Acetylcysteine	Makes it, tests it and packages it	Glenmark Pharmaceuticals Inc., USA	68462-946
Acyclovir	Makes it, tests it, packages it and labels it	Fresenius Kabi USA, LLC	65219-622, 65219-624
Alcohol	Makes it, tests it, packages it and labels it	Breckenridge Pharmaceutical, Inc.	51991-999
Baclofen	Makes it, tests it, packages it, labels it and sterilizes it	Advagen Pharma Ltd., Nexus Pharamaceuticals Inc.	72888-145, 72888-146, 72888-147 +1
Calcitonin Salmon	Makes it, tests it and packages it	Cipla USA., Inc.	69097-770
Chlorothiazide	Makes it and tests it	Caraco Pharmaceutical Laboratories, Ltd.	47335-330
Chlorpromazine	Makes it	Fresenius Kabi USA, LLC	65219-128, 65219-130
Chromic Cation	Makes it	Archis Pharma LLC	72819-235
Cupric Cation	Makes it	Archis Pharma LLC, Northstar Rx LLC., Renova Pharmaceuticals LLC	72819-234, 72603-351, 84897-013
Hydralazine	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	43066-041
Hydrocortisone	Makes it, tests it, packages it and labels it	Cipla USA., Inc.	69097-004
Isoproterenol	Makes it	STI Pharma LLC	54879-039
Micafungin	Makes it	Biocon Pharma Inc.	70377-075, 70377-076
Norepinephrine	Makes it, tests it, packages it, labels it and sterilizes it	Biocon Pharma Inc., Rising Pharma Holdings, Inc.	70377-121, 64980-630
Pentamidine	Makes it, tests it, packages it and labels it	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-748
Phytonadione	Makes it	Cipla USA., Inc.	69097-708, 69097-709
Tranexamic Acid	Makes it, tests it, packages it and labels it	Milla Pharmaceuticals Inc., Provepharm Inc.	71357-017, 71357-018, 81284-611 +1

FDA inspection history

Ended	Result	Program	Problems noted
Sep 18, 2025	Serious problems, FDA action	Drug Quality Assurance	—
Mar 14, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jun 20, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	—

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Mar 14, 2023 inspection

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.

Registered with FDA for: analysis; label; manufacture; pack; sterilize.