Sertraline 50mg tablets

2.0 Bill of materials for product manufacturing Batch Size: 15,00,000 Tablets
2.1 Active Pharmaceutical Ingredient
Qty/ Qty/ Actual qty to
Name of Active Item
S. No. Tablet Batch be dispensed
Pharmaceutical ingredient code
(mg) in kg in kg
1 Sertraline hydrochloride BP/Ph.Eur (COS) A039 55.960 83.940 83.940
2.2 Excipients
Actual qty
Qty/ Qty/
Item to be
S. No. Name of Ingredient tablet Batch in
code dispensed in
(mg) kg
kg
Cellulose microcrystalline (Avicel PH-101)
1 E139 27.458 41.187 41.187
Ph.Eur
Calcium hydrogen phosphate dihydrate
2 E140 24.000 36.000 36.000
Ph.Eur
Low substituted Hydroxy propyl cellulose
3 E142 4.500 6.750 6.750
(L-HPC) (LH-21) Ph.Eur
Sodium starch glycolate (Type A) BP/
4 E141 2.917 4.376 4.376
Ph.Eur
5 Magnesium stearate BP / Ph.Eur E016 0.938 1.407 1.407
Extra granular materials and lubrication
Cellulose microcrystalline (Avicel PH-
6 E139 27.457 41.186 41.186
101) Ph.Eur
Sodium starch glycolate (Type A) BP/
7 E141 5.833 8.750 8.750
Ph.Eur
8 Magnesium stearate BP/ Ph.Eur E016 0.937 1.406 1.406
Core tablet weight 150.00 225.00 225.00
2.3 Coating materials
1 Opadry white IH (Product No YS-1R-7003) E138 4.500 6.7500 8.775@
2 Purified water Ph.Eur * E005 Q.S Q.S Q.S
3 Opadry clear IH (Product No YS-1R-7006) E135 0.500 0.75 0.975@
4 Purified water Ph.Eur * E005 Q.S Q.S Q.S
Coated tablet weight 155.00 - -
 Packing details

4.0 Material details for primary packaging material

Type Specifications
Base foil PVC (200 micron) with PVdC (60gsm) white opaque film
Primary pack Aluminium foil
Lidding foil
Thickness: 0.02 mm
Sertraline 100mg tablets

2.0 Bill of materials for product manufacturing Batch Size: 7,50,000 Tablets
2.1 Active Pharmaceutical Ingredient
Qty/ Qty/ Actual qty
Name of Active Item to be
S. No. tablet Batch
Pharmaceutical ingredient code dispensed
(mg) in kg
1 Sertraline hydrochloride BP/Ph.Eur (COS) A039 111.920 83.940 in kg
83.940
2.2 Excipients
Actual qty
Qty/ Qty/
Item to be
S. No. Name of Ingredient tablet Batch in
code dispensed
(mg) kg
in kg
Cellulose microcrystalline (Avicel PH-
1 E139 54.916 41.187 41.187
101) Ph.Eur
Calcium hydrogen phosphate dihydrate
2 E140 48.000 36.000 36.000
Ph.Eur
Low substituted Hydroxy propyl cellulose
3 E142 9.000 6.750 6.750
(L-HPC) (LH-21) Ph.Eur
Sodium starch glycolate (Type A) BP/
4 E141 5.834 4.376 4.376
Ph.Eur
5 Magnesium stearate BP / Ph.Eur E016 1.876 1.407 1.407
Extra granular materials and lubrication
Cellulose microcrystalline (Avicel PH-
6 E139 54.914 41.186 41.186
101) Ph.Eur
Sodium starch glycolate (Type A) BP/
7 E141 11.666 8.750 8.750
Ph.Eur
8 Magnesium stearate BP/ Ph.Eur E016 1.874 1.406 1.406
Core tablet weight 300.00 225.00 225.00
2.3 Coating materials
1 Opadry white IH (Product No YS-1R-7003) E138 9.000 6.750 8.775@
2 Purified water Ph.Eur * E005 Q.S Q.S Q.S
3 Opadry clear IH (Product No YS-1R-7006) E135 1.000 0.75 0.975@
4 Purified water Ph.Eur * E005 Q.S Q.S Q.S
Coated tablet weight 310.00 - -
 Sertraline packing details

4.0 Material details for primary packaging material

Type Specifications
Base foil PVC (200 micron) with PVdC (60gsm) white opaque film
Primary pack Aluminium foil
Lidding foil
Thickness: 0.02 mm
 Propranolol hydrochloride 10mg tablets

2.0 Bill of materials for product manufacturing Batch Size: 10,00,000

Tablets
2.1 Active Pharmaceutical Ingredient

S. Name of Active Item Qty/ tablet Qty/ Batch

Specification
No. Pharmaceutical ingredient code (mg) in kg

1 Propranolol hydrochloride A025 BP/Ph.Eur 10.000 10.00

2.2 Excipients
S. Item Qty/ Qty/ Batch
Name of Ingredient Specification
No. code tablet (mg) in kg

Lactose monohydrate (SuperTab

1 E072 BP/Ph.Eur 86.000 86.000
11 SD)
2 Purified Talc E045 BP/Ph.Eur 2.000 2.000
3 Stearic acid E076 BP/Ph.Eur 2.000 2.000
4 Magnesium stearate E016 BP/Ph.Eur 0.250 0.250
Core tablet weight 100.250 100.250
2.3 Coating materials
Opadry pink (Product
1 E087 IH 4.50 5.40@
No:03B84998)
2 Purified water* E005 Ph.Eur q.s. q.s.
Coated tablet weight 104.75 -

4.0 Material details for primary and secondary packaging material

Type Specifications

Base foil PVC (250 micron) / PVdC (90 GSM) white Opaque 0.25 mm
Primary pack
Lidding foil Printed Aluminium foil 0.025 mm
Propranolol 40mg tablets

2.0 Bill of materials for product manufacturing Batch Size: 10,00,000

Tablets
2.1 Active Pharmaceutical Ingredient

S. Name of Active Qty/ Batch

Item code Qty/ tablet (mg)
No. Pharmaceutical ingredient in kg

1 Propranolol hydrochloride BP/Ph.Eur A025 40.000 40.000

2.2 Excipients
S. Qty/ Qty/ Batch in
Name of Ingredient Item code
No. tablet (mg) kg
Lactose monohydrate (Super Tab 11 SD)
1 E072 147.000 147.000
BP/Ph.Eur
2 Microcrystalline cellulose M102 E073 10.00 10.000
BP/Ph.Eur
3 Purified Talc BP/Ph.Eur E045 4.000 4.000
4 Stearic acid BP/Ph.Eur E076 4.000 4.000
5 Magnesium stearate BP/Ph.Eur E016 0.512 0.512
Core tablet weight 205.512 205.512
2.3 Coating materials
1 Opadry pink Product No:03B84998 IH E087 9.20 11.04@
Coated tablet weight 214.712 -

4.0 Material details for Primary and Secondary packaging material

Type Specification

Base foil PVC (250 micron) / PVdC (90 GSM) white Opaque 0.25 mm
Primary Pack
Lidding foil Printed Aluminium foil 0.025mm
 Paracetamol 500mg tablets

2.0 Bill of materials for product manufacturing Batch Size: 10,00,000 Tablets
2.1 Active pharmaceutical ingredient
Name of active Item Qty/table Quantity /
S. No. Specification
pharmaceutical ingredient code t (mg) Batch (Kg)
1 Paracetamol BP/Ph.Eur A016 BP/Ph.Eur 500.00 500.00
2.2 Excipients
Item Qty/table Quantity /
S. No. Name of Ingredient Specification
code t (mg) Batch (Kg)
Starch 1500 Partially Pregelatinised
2 E053 Ph.Eur 36.50 36.50
maize starch
2.3 Binder
3 Povidone K30 (Taylauk K30) E060 BP/Ph.Eur 12.50 12.50
4 Purified Water# E005 Ph.Eur q.s. 90.00
2.4 Extra Granular
Sodium starch glycolate Type A
5 E029 BP/Ph.Eur 4.00 4.00
(Primojel)
6 Stearic Acid E076 BP 2.50 2.50
Colloidal silicon dioxide (Anhydrous)
7 E026 BP/Ph.Eur 2.70 2.70
(Cab-o-sil ® Grade-M-5)
Total 558.20 558.20

4.0 Material details for primary and secondary packaging material

Type Specifications

Base foil Clear PVC film (253mm X 0.25mm)

Primary pack

Lidding foil Printed Aluminium foil (249mm X 0.02mm )

P01P02T 155 X 130 X 130 mm

Secondary pack
Carton
P02P02T 155 X 130 X 130 mm