Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of US$ 48 million for twelve months ending December 2024 according to IQVIA
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
Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA
Construction of the plant will commence in 2025 with first production expected to be in 2027
EDQM has also issued a Certificate of Suitability for Allopurino
Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term treatment of Erosive Esophagitis associated with GERD
Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US $512 million for twelve months ending Sep 2022 according to IQVIA
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