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