Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal
The USFDA has issued 5 observations pursuant to the completion of audit
The USFDA has issued 5 observations pursuant to the completion of audit
Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients
Approval from Colombia's INVIMA will accelerate growth in Colombia, by registering our product and getting regular supplies
Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US
NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A
Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market
This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy
FDA has concluded that this inspection is 'closed'
Submission based on results from pivotal phase III trial showing all primary endpoints met
Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024
This facility manufactures APIs & formulations of oncology and non-oncology products.
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly
The company will respond to the Warning Letter within the stipulated timelines
These observations are procedural in nature and will be responded within the stipulated time
The observations are procedural in nature and will be responded to within the stipulated time
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