Drug Approval | July 26, 2022
Zydus receives final approval from the USFDA for Bisoprolol Fumarate Tablets
Bisoprolol Fumarate Tablets are used to treat high blood pressure.
Bisoprolol Fumarate Tablets are used to treat high blood pressure.
Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).
Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.
Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S
Lacosamide Injection is used to treat partial-onset seizures.
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi
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