Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories
Zyrifa is indicated for patients with bone metastases stemming from a wide range of solid tumors
This inspection was conducted following the warning letter issued by the USFDA
RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US
FDA closes inspection at Zydus' oncology injectable manufacturing facility in SEZ1, Ahmedabad with 2 observations
Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer
Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis
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