Theor. % Theor. % Theor. % Theor. % quantity per quantity quantity quantity batch per batch per batch per batch <complete with appropriate titles e.g. Core tablet (Layer 1, Layer 2, etc. as applicable), Contents of capsule, Powder for injection> Subtotal 1 <complete with appropriate title e.g. Film-coating > Subtotal 2 Total 2.3.P.3 Manufacture 2.3.P.3.1 Manufacturer(s) Name, address and responsibility (e.g. fabrication, packaging, labelling, testing) of each manufacturer, including contractors and each proposed production site or facility involved in manufacturing and testing: Name and address Responsibility (include block(s)/unit(s)) 2.3.P.3.2 Batch Formula Largest intended commercial batch size: Other intended commercial batch sizes: <information on all intended commercial batch sizes should be in the QIS> (a) List of all components of the FPP to be used in the manufacturing process and their amounts on a per batch basis (including components of mixtures prepared in-house (e.g. coatings) and overages, if any):
Theor. quantity per batch % Theor. quantity per batch % Theor. quantity per batch % Theor. quantity per batch % <complete with appropriate titles e.g. Core tablet (Layer 1, Layer 2, etc. as applicable), Contents of capsule, Powder for injection> Subtotal 1 <complete with appropriate title e.g. Film-coating > Subtotal 2 Total 2.3.P.3 Manufacture 2.3.P.3.1 Manufacturer(s) Name, address and responsibility (e.g. fabrication, packaging, labelling, testing) of each manufacturer, including contractors and each proposed production site or facility involved in manufacturing and testing: Name and address (include block(s)/unit(s)) Responsibility 2.3.P.3.2 Batch Formula Largest intended commercial batch size: Other intended commercial batch sizes: <information on all intended commercial batch sizes should be in the QIS> (a) List of all components of the FPP to be used in the manufacturing process and their amounts on a per batch basis (including components of mixtures prepared in-house (e.g. coatings) and overages, if any):
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