This certification validates the plant’s robust capabilities in manufacturing a wide range of sterile dosage forms
Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug
The inspection was conducted from July 22-25, 2025
The company received one observation in the Form-483
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India
Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad
FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths
European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)
The company is addressing these observations comprehensively
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
The receipt of EIR reaffirms the company's commitment to maintaining global quality standards
Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments
Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,
Celecoxib is a nonsteroidal anti-inflammatory drug
Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease
This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product
The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
The audit has been concluded with no major observations
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