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 has filed its first ANDA in July 2016, and is expecting US FDA inspection within Q1-2017. Caplin also has a pipeline of 8 more ANDAs to be filed before Q2 – 2017.