The product is available in a single-strength fixed dose, with a recommended once-daily dosage.
Canagliflozin Tablets (RLD Invokana) had estimated annual sales of USD 561 million in the U.S. (IQVIA MAT September 2023).
Bromfenac Ophthalmic Solution (RLD Prolensa) had estimated annual sales of USD 185 million in the U.S. (IQVIA MAT September 2023).
Pitavastatin Tablets (RLD Livalo) had estimated annual sales of USD 298 million in the U.S. (IQVIA MAT September 2023).
Rocuronium Bromide Injection (RLD: Zemuron) had estimated annual sales of USD 54 million in the U.S. (IQVIA MAT August 2023).
This product will be manufactured at Lupin’s Pithampur facility in India.
The inspection closed with the facility receiving an inspection classification of “No Action Indicate” (NAI).
This product will be manufactured at Lupin’s Pithampur facility in India.
Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch, the company stated.
This product will be manufactured at Lupin’s Nagpur facility in India.
Individuals living with the illness are at increased risk of developing multiple complications, including heart disease, stroke, kidney ailments, nerve…
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).
“This strategic acquisition for the Indian market marks a significant step forward for Lupin as it continues to expand its…
Pirfenidone Capsules (RLD Esbriet) had estimated annual sales of USD 95 million in the U.S. (IQVIA MAT June 2023).
This acquisition strengthens Lupin’s commitment to providing superior treatment options for patients navigating the complexities of diabetes, it claimed.
Tiotropium Bromide Inhalation Powder (Reference Product Spiriva HandiHaler) had estimated annual sales of USD 1,264 million in the US (IQVIA…
This product will be manufactured at Lupin’s Pithampur facility in India.
According to the company’s press statement, the approval is to market a generic equivalent of Toprol-XL Tablets, 25 mg, 50…