The document provides details of the manufacturing formula for Mebendazole tablets, including the composition of active and inactive ingredients. It lists mebendazole as the active ingredient at 100mg per tablet. The other inactive excipients are Ludipress at 196mg per tablet as a disintegrant and magnesium stearate at 4mg per tablet as a lubricant. The batch size for production is listed as 100,000 tablets.
Original Description:
Original Title
17a. composition (active & inactive) 500 - Copy
The document provides details of the manufacturing formula for Mebendazole tablets, including the composition of active and inactive ingredients. It lists mebendazole as the active ingredient at 100mg per tablet. The other inactive excipients are Ludipress at 196mg per tablet as a disintegrant and magnesium stearate at 4mg per tablet as a lubricant. The batch size for production is listed as 100,000 tablets.
The document provides details of the manufacturing formula for Mebendazole tablets, including the composition of active and inactive ingredients. It lists mebendazole as the active ingredient at 100mg per tablet. The other inactive excipients are Ludipress at 196mg per tablet as a disintegrant and magnesium stearate at 4mg per tablet as a lubricant. The batch size for production is listed as 100,000 tablets.
COMPOSITION (ACTIVE & EXCIPIENTS) INCLUDING STATEMENT OF QUANTITATIVE COMPOSITION, GIVING THE WEIGHT OR MEASURE FOR EACH ACTIVE SUBSTANCE USED IN THE MANUFACTURE OF DOSAGE FORM
S# INGREDIENTS SPECIFICATI QUANTITY QUANTITY ROLE OF
ONS PER USED PER INGREDIENTS ACTIVE DOSAGE BATCH FORM
1A Mebendazole USP 100 mg 10 Kg Active
IN-ACTIVE SPECIFICATI QUANTITY QUANTITY ROLE OF
(EXCIPIENTS) ONS PER USED PER INGREDIENTS DOSAGE BATCH FORM 1) Ludipress USP 196 mg 19.6 Kg Disintegrant 2) Magnesium Stearate USP 4 mg 0.4Kg Lubricant