NCD Mental Health Drug specification 2074(Full Descriptions Included)

  • NCD Mental Health Drug specification 2074(Full Descriptions Included)

    Diazepam Tablets 2mg
    INN/Generic Name  Diazepam  Tablets
     
    Dosage form Tablets
     
    Strength Eachtablet  contains-
    Diazepam  2mg
     
    Standard API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
     
    Basic Unit  1×10 Tablets Blister pack
     
    Primary Pack Diazepam tablets should be packed in an Aluminum-  amber / opaque PVC film blister pack.
     
    PVC film thickness : NLT 250 micron & NLT 350 gsm.
     
    Aluminum Foil Thickness : NLT 25 micron & NLT 60 gsm.
     
    Quantity primary pack in supply unit 10 Blisters each containing 10 Diazepam tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
     
    Special Storage Store protected from light .
     
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
     

     

    Metformin Tablets 850mg
    INN/Generic Name  Metformin hydrochloride Tablets
     
    Dosage form Tablets
     
    Strength Each tablet  contains-
    Metformin  HCl              850mg.
     
    Standard API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
     
    Basic Unit  1×10 Tablets Blister pack
     
    Primary Pack 10 Metformin Tablets should be packed in an Aluminum- PVDC coated PVC film blister pack.
     
    PVC film Thickness : NLT 250 micron with 60 gsm PVDC coating
     
    Aluminum Foil Thickness : NLT 25 micron
     
    Quantity primary pack in supply unit 10 Blisters each containing 10 Metformin tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT5  ply.
     
    Special Storage Store at room temperature.
     
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
     

     

    Hydrochlorothiazide Tablets 12.5mg
    INN/Generic Name Hydrochlorothiazide Tablets
     
    Dosage form Tablets
     
    Strength Each tablet contains-
    Hydrochlorothiazide                        12.5mg
     
    Standard API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
     
    Basic Unit 1×10 Tablets blister pack
     
    Primary Pack Hydrochlorothiazide tablets should be packed in an Aluminum- PVC film blister pack.
     
    PVC film thickness : NLT 250 micron & NLT 350 gsm.
     
    Aluminum Foil Thickness : NLT 25 micron & NLT 60 gsm.
     
    Quantity primary pack in supply unit 10 blisters each containing 10 Hydrochlorothiazide tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
     
    Special Storage  Preserve in well closed containers.
     
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store
     

     

    Enalapril Tablets 2.5 mg
    INN/Generic Name Enalapril  Maleate Tablets
     
    Dosage form Tablets
     
    Strength Each film coated  tablet  contains-
    Enalapril Maleate          2.5mg.
     
    Standard API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
     
    Basic Unit  1×10 Tablets Blister pack
     
    Primary Pack Enalapril Tablets should should be packed in an Aluminum-PVDC coated PVC film blister pack.
     
    PVC film thickness : NLT 250 micron with 60 gsm PVDC coating
     
    Aluminum Foil Thickness : NLT 25 micron
     
     
    Quantity primary pack in supply unit 10 Blisters each containing 10 Enalapril tablet are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
     
    Special Storage Store at room temperature.
     
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
     

     

    EnalaprilTablets 5 mg
    INN/Generic Name Enalapril  Maleate  Tablets
     
    Dosage form Tablets
     
    Strength Each Film Coated tablet  contains-
    Enalapril Maleate                   5mg.
     
    Standard API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
     
    Basic Unit  1×10 Tablets Blister pack
     
    Primary Pack Enalapril Tablets should  be packed in an Aluminum-PVDC coated PVC film blister pack.
     
    PVC film thickness : NLT 250 micron with 60 gsm PVDC coating
     
    Aluminum Foil Thickness : NLT 25 micron
     
    Quantity primary pack in supply unit 10 Blisters each containing 10 Enalapril tablet are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
     
    Special Storage Store at room temperature.
     
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
     

     

    Risperidone Tablets 1mg
    INN/Generic Name Risperidone Tablet
    Dosage form Tablets
     
    Strength Each Film Coated  tablet  contains-
    Risperidone  1mg
     
     
    Standard API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
     
    Basic Unit  1×10 Tablets Blister pack
    Primary Pack Risperidone  tablets should be packed in an Aluminum-  amber / opaque PVC film blister pack.
     
    PVC film thickness : NLT 250 micron & NLT 350 gsm.
     
    Aluminum Foil Thickness : NLT 25 micron & NLT 60 gsm.
    Quantity primary pack in supply unit 10 blisters each containing 10 Risperidone Tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono cartons packed in cardboard carton NLT 3 ply.
     
    Special Storage Preserve at tight , light resistant containers.
     
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
     

     

    Risperidone Tablets 2 mg
    INN/Generic Name Risperidone Tablet
    Dosage form Tablets
     
    Strength Each Film Coated tablet  contains-
    Risperidone   2mg
     
    Standard API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
     
    Basic Unit  1×10 Tablets Blister pack
    Primary Pack Risperidone tablets should be packed in an Aluminum-  amber/ opaque PVC film blister pack.
     
    PVC film thickness : NLT 250 micron & NLT 350 gsm.
     
    Aluminum Foil Thickness : NLT 25 micron & NLT 60 gsm.
    Quantity primary pack in supply unit 10 blisters each containing 10 Risperidone Tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono cartons packed in cardboard carton NLT 3 ply.
     
    Special Storage Preserve at tight , light resistant containers.
     
     
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
     

     

      Fluoxetine Capsules 10mg
    INN/Generic Name Fluoxetine Hydrochloride Capsule, Fluoxetine Capsules
    Dosage form Capsules
     
    Strength Each Capsule contains-
    Fluoxetine  10mg
     
    Standard API should meet the monograph requirement/capsule should meet general requirement stated under  capsule and specific requirement of the   individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043
    Basic Unit 1×10 Capsules blister pack.
    Primary Pack Fluoxetine Capsules should be packed in an Aluminum- PVDC coated PVC film blister pack.
     
    PVC film thickness : NLT 250 micron with 60gsm PVDC coating
     
    Aluminum Foil Thickness : NLT 25 micron
     
     
     
    Quantity primary pack in supply unit 10 blisters each containing 10Fluoxetinecapsules are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono cartons packed in cardboard carton NLT 3 ply.
     
    Special Storage Store protected from moisture.
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.

     

      Fluoxetine Capsules 20mg
    INN/Generic Name Fluoxetine Hydrochloride Capsule, Fluoxetine Capsules.
    Dosage form Capsules
     
    Strength Each Capsule contains-
    Fluoxetine  20mg
     
    Standard API should meet the monograph requirement/capsule should meet general requirement stated under  capsule and specific requirement of the   individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043
    Basic Unit 1×10 Capsules blister pack.
    Primary Pack Fluoxetine Capsules should be packed in an Aluminum- PVDC coated PVC film blister pack.
     
    PVC film thickness : NLT 250 micron with 60gsm PVDC coating
     
    Aluminum Foil Thickness : NLT 25 micron
     
     
    Quantity primary pack in supply unit 10 blisters each containing 10 Fluoxetine capsules are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono cartons packed in cardboard carton NLT 3 ply.
     
    Special Storage Store protected from moisture.
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.

     

    Sodium Valproate Gastro –Resistant Tablets 200mg
    INN/Generic Name Sodium Valproate Gastro –Resistant Tablets , Gastro – Resistant Sodium Valproate Tablets.
    Dosage form Tablets
     
    Strength  
    Each enteric coated  tablet  contains-
    Sodium Valproate  200mg
     
    Standard API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and  specific requirement of the   individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
     
    Basic Unit  1×10 Tablets strippack
    Primary Pack Sodium Valproate Tablets should be packed in an Aluminum-Aluminum Strip pack.
     
    Aluminum foils thickness –NLT 40 micron and 60 gsm.
     
     
    Quantity primary pack in supply unit 10 Blisters each containing 10 Sodium Valproate  tablet are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
     
    Special Storage Store protected from moisture.
     
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
     

     

    Sodium Valproate Gastro –Resistant Tablets 300mg
    INN/Generic Name  Sodium Valproate Gastro –Resistant Tablets , Gastro – Resistant Sodium Valproate Tablets
    Dosage form Tablets
     
    Strength Each enteric coated  tablet  contains-
    Sodium Valproate   300mg
     
     
    Standard API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
     
    Basic Unit  1×10 Tablets Blister pack
    Primary Pack Sodium Valproate  Tablets should be packed in an Aluminum-Aluminum Strip pack.
     
    Aluminum foils thickness –NLT 40 micron and 60 gsm.
    Quantity primary pack in supply unit 10 Blisters each containing 10 Sodium valproate tablet are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
     
    Special Storage Store protected from moisture .
     
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
     

     

    Trihexiphenidyl Tablet 2mg
    INN/Generic Name Trihexyphenidyl Hydrochloride Tablet
    Dosage form  
    Tablet
    Strength Each  tablet  contains-
    TrihexyphenidylHCl 2mg
     
     
    Standard API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
     
    Basic Unit  1×10 Tablets Blister pack
    Primary Pack Trihexyphenidyl tablets should be packed in   an Aluminum- PVDC coated  amber / opaque PVC film blister pack.
     
    PVC film thickness : NLT 250 micron with 60gsm PVDC coating
     
    Aluminum Foil Thickness : NLT 25 micron
     
     
    Quantity primary pack in supply unit 10 Blisters each containing 10 Trihexyphenidyl  tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
     
    Special Storage Preserve in tight containers.
     
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
     

     

    Thiamine tablet 100mg
    INN/Generic Name Thiamine Hydrochloride Tablet
    Dosage form Tablets
     
    Strength Each   tablet  contains-
    Thiamine hydrochloride   100mg
     
    Standard API should meet the monograph requirement/Tablet should meet general requirement stated under tablet and specific requirement of the individual product monograph given in any pharmacopoeia recognized by Drug Standard Regulation 2043.
     
    Basic Unit  1×10 Tablets Blister pack
    Primary Pack Thiamine Tablets should be packed in an Aluminum-  PVDC coated  amber colored / opaque PVC film blister pack.
     
    PVC film thickness : NLT 250 micron with 60gsm PVDC coating
     
    Aluminum Foil Thickness : NLT 25 micron
     
     
    Quantity primary pack in supply unit 10 Blisters each containing 10 Thiamine  tablets are packed in a printed mono carton (NLT 300 gsm) for secondary packaging. 100 such mono carton packed in cardboard carton NLT 3 ply.
     
    Special Storage Store protrected from light and moisture in non metalic containers.
     
    Shelf Life Minimum 24 Months. At least 3/4th shelf life must be available at the time of delivery to the designated store.
     

    Sources : WHO/MoHP Nepal