The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 m
This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.
Granules now has a total of 58 ANDA approvals from US FDA
Against targeted investment of Rs. 3,938 crore, investments worth Rs. 4,024 crores have been made under scheme
The National Institute of Pharmacy and Nutrition, Hungary has issued 'Certificate of GMP Compliance of Manufacturer' for IOL Chemicals and Pharmaceuticals Limited's products.
The company registered with REACH Certificate for Ethyl Acetate with a tonnage band of more than 1000 TPA
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