《32P3》.pdf

Allergy 24 Tablets 3.2.P Drug Product 3.2.P.3 Manufacture 3.2.P.3 Manufacture (Allergy 24, Tablet) 3.2.P.3.1 Manufacturer (Allergy 24, Tablet) Finished product manufacturing, packing, labelling, testing and release for supply of Allergy 24 Tablets is carried out by: Sunshine Lake Pharma Co. Ltd No. 1 Northern Industry Road Northern Industry Park of Song Shan Lake Dongguan Guangdong 523808 China GMP Clearance ID: MI-2012-CL-05919-3 3.2.P.3.2 Batch Formula (Allergy 24, Tablet) Batch size: 50.305kg (120,000 tablets) Ingredient Quantity (Kg) Quality Standard Fexofenadine hydrochloride 14.545 USP Cellulose - microcrystalline (PH101) 12.000 Ph. Eur. Cellulose - microcrystalline (PH102) 15.216 Ph. Eur. Starch - pregelatinised maize 3.120 Ph. Eur. Croscarmellose sodium 2.789 Ph. Eur. Magnesium stearate 0.480 Ph. Eur. OPADRY complete film coating 2.170 In-house system 03B54504 Pink (PI. 12711) Purified water qs Ph. Eur. There are no overages. 04 Feb 2015 3.2.P.3 Page 1 of 5 Allergy 24 Tablets 3.2.P Drug Product 3.2.P.3 Manufacture 3.2.P.3.3 Description of Manufacturing Process and Process Controls (Allergy 24, Tablet) Flow Chart of Manufacturing Process Batch Size: 50.305 kg (120,000 Tablets) 04 Feb 2015