Drug Approval | July 18, 2025
Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2
The company is addressing these observations comprehensively
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
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
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery
Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma
The inspection concluded with zero Form 483 observations
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults
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