Shilpa Pharma Lifesciences’ Unit II, Raichur, Karnataka clears PMDA Japan, GMP inspection
The inspection has concluded successfully on 1st September 2023 without any critical/major observation
The inspection has concluded successfully on 1st September 2023 without any critical/major observation
Shilpa Medicare Limited is the first company to receive approval for Manufacturing & Market of Pemetrexed Injection 10 ml, 50 ml, 85 ml, and 100 ml in India
The company is already marketing the 4 mg and 10 mg strengths
This is the second US FDA GMP inspection of this facility within one year
The company will be submitting the responses to US FDA observations within stipulated timeline
This registration enables companies to register the products (Orodispersible films and Transdermal systems) in UAE for commercialization
The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties
The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing
The GMP facility is equipped with state of art machinery for the needs of Global commercial requirements
 
        Subscribe To Our Newsletter & Stay Updated