Zydus receives final approval from USFDA for Fludrocortisone Acetate Tablets USP, 0.1 mg
Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad
Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad
Granules now has a total of 67 ANDA approvals from the USFDA
VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w
Indoco is comprehensively working on the remedial action plan
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
This is used to treat central diabetes insipidus and bedwetting
Alcaftadine Ophthalmic Solution, 0.25% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander
Cetirizine is used for relief of symptoms of hay fever and other allergic conditions
Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures
This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated
The product is expected to be launched in Q3FY25
The inspection conducted by EDQM at its Visakhapatnam facility
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
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