Transcription of Form 44 - Central Drugs Standard Control …
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Form 44 - Central Drugs Standard Control …
form 44 (See rules 122a , 122B, 122D and APPLICATION FOR GRANT OF PERMISSION TO IMPORT OR MANUFACTURE A NEW DRUG OR TO UNDERTAKE CLINICAL TRIAL. I/We* - - - - - - - - - - - - - - of M/s , - - - - - - - - - -( a d dr e s s )hereby apply for grant of permission for import and/or clinical trial or for approval to manufacture a new drug or fixed dose combination or subsequent permission for already approved new drug. The necessary information / date is given below: 1. Particulars of New Drug : (1) Name of the dr ug : (2) Do sa ge Fo rm : (3) Co mpositio n of the formulation : Ingredient Pharmacopical Monograph Category Percentage of Claim of Quantity Strength (4) Test specification : (i) Active ingredients : (ii) Inactive ingredients : (5) Pharmaco)
Form 44 (See rules 122A, 122B, 122D and APPLICATION FOR GRANT OF PERMISSION TO IMPORT OR MANUFACTURE A NEW DRUG OR TO UNDERTAKE CLINICAL TRIAL. I/We* ----- of M/s , -----(address)hereby apply …
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