The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA
Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle
Prucalopride is prescribed for chronic idiopathic constipation
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India
Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad
Celecoxib is a nonsteroidal anti-inflammatory drug
Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery
The inspection concluded with zero Form 483 observations
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