CREDENTIALS AND APPROVALS
EU-GMP :Caplin Point’s CP-IV facility has been approved by EU-GMP for manufacture and supply of Sterile Liquid and Lyophilized Injectables and Ophthalmic dosages for European Union.
ANVISA :EU-GMP : Caplin Point’s CP-IV facility has been approved by Brazil’s ANVISA agency, for manufacture and supply of Sterile Liquid and Lyophilized Injectables and Ophthalmic dosages for Brazil.
US FDA :Caplin filed its first ANDA in July 2016. Since then 10 ANDAs have been filed till date with 4 approved and further approvals awaited. About 10 more to be filed by December 2019.