LEON PHARMACEUTICALS LIMITED

Satkhamair, Sreepur, Gazipur.

Storage : Central Document Store of QA

Distribution : 1. Commercial Department
2. QA/QC Department
3. Warehouse &
4. Product Development

Product Data Sheet

Product Name : Novacal-D 50S Tablet DAR No. : 230-15-078

Batch size (Wt.) : 85.764 kg Product Code : NCT051
Batch size (Nos.) : 60,000 Pack size : 05 x 10S
Weight per Tablet: 1429 mg Blister Size: 50x123 mm Pack / Batch : 1200 Nos

Sl. Code No. / Description Specificati Unit Quantity. Unit Quantity

No. Material No. ons /Tablet /Batch
Active Pharmaceutical Ingredients
BP/USP g kg
01 LAI-006 Calcium Carbonate USP mg 1250.00 kg 75.750

Excipients
01 LII-019 Lactose USNF mg 40.00 kg 1.650
02 LII-025 Avicel (PH101) BP mg 20.00 kg 1.200
03 LII-022 Maize Starch (Paste) Ph.Grade mg 60.00 kg 3.600
04 LII-034 Povidone K-30 (Paste) mg 30.00 kg 1.800
05 LII-037 Water (DM) ml 0.35 lit 21.00
06 LII-021 Magnesium Stearate (Lubrication ) mg 5.00 kg 0.300
07 LII-008 Aerosil 200 mg 2.00 kg 0.120
08 LII-046 Sodium Starch Glycolate mg 20.00 kg 1.200
09 LII-012 Vitamin D3 mg 2.00 kg 0.144
10 LII-017 HPMC 15 cps mg 10.00 kg 0.600
11 LII-048 Titanium Dioxide mg 3.00 kg 0.180
12 LII-032 PEG 6000 mg 0.24 kg 0.014
13 LII-036 Purified Talc mg 0.65 kg 0.039
14 LII-018 Isopropyl Alcohol ml 0.10833 lit 6.500
15 LII-009 Methylene Chloride ml 0.10833 lit 6.500
Packaging Materials
Unit Qty./Pack Unit Qty./Batch
01 LTF -047 Printed Aluminium Top Foil of Novacal-D Tablet gm 2.37 kg 2.844
02 Polyvinylidene Chloride (PVDC) Silver-white Foil 214 gm 16.038 kg 19.24
LBF -010
mm
03 LIC-065 Inner Carton of Novacal-D Tablet pc 01 pcs 1236
04 LIS-048 Insert of Novacal-D Tablet pc 01 pcs 1236
05 LMC-004 Master Carton General 420mmx330mmx260mm pc - pcs 12
06 Gum tape (large) 01
07 Gum tape (small) 01

* Calculated amount of materials

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Prepared by Checked by Approved by
 LEON PHARMACEUTICALS LIMITED
Satkhamair, Sreepur, Gazipur.

Storage : Central Document Store of QA

Distribution : 1. Commercial Department
2. QA/QC Department
3. Warehouse &
4. Product Development

Product Data Sheet

Product Name : RABOZ 20 TABLET DAR No. : 230-83-067

Batch size (Wt.) : 43.00 kg Product Code : RBT048
Batch size (Nos.) : 200000 Tablets Pack size : 5 10S
Weight per Tablet (Core/Coated) : 215.00 mg/247.4 mg Pack / Batch : 4000

Sl. Code No. / Description Specificati Unit Quantity. Unit Quantity

No. Material No. ons /Tablet /Batch
Active Pharmaceutical Ingredients
BP/USP mg kg
01 LAI-070 Rabeprazole Sodium USP mg 20 kg 4.150

Excipients
01 DG-001 Dummy Granules-LPA101/16 BP mg 86.25 kg 17.100
02 LII-026 Avicel PH 102 BP mg 39.75 kg 7.950
03 LII-023 Mannitol BP mg 22.00 kg 4.400
04 LII-065 Pregelatinised Starch BP mg 11.00 kg 2.200
05 LII-069 Sodium Carbonate Anhydrous BP mg 25.00 kg 5.000
06 LII-059 Crospovidone BP mg 8.00 kg 1.600
07 LII-021 Magnesium Stearate BP mg 3.00 kg 0.600
Coating Materials

01 LII-017 HPMC 15 Cps (Seal Coat) BP mg 3.300 kg 0.600

02 LII-018 Isopropyl Alcohol (Seal Coat) BP ml 0.030 Lit 6.000
03 LII-009 Methylene Chloride (Seal Coat) BP ml 0.03 Lit 6.000
04 LII-015 Eudragit L-100 (Enteric Coat) BP mg 19.8 kg 3.960
05 LII-048 Titanium Dioxide (Enteric Coat) BP mg 1.683 kg 0.337
06 LII-032 PEG 6000 (Enteric Coat) BP mg 1.683 kg 0.337
07 LII-036 Purified Talc (Enteric Coat) BP mg 5.94 kg 1.188
08 LII-084 Apple Green (Enteric Coat) Ph. Grade mg 0.033 kg 0.0066
09 LII-018 Isopropyl Alcohol (Enteric Coat) Ph. Grade ml 0.30 lit 60.00
Packaging Materials
Unit Qty./Pack Unit Qty./Batch
01 LTF-059 Printed Aluminium Top Foil of Raboz Tablet gm 2.781 kg 11.12
02 LBF-009 Unprinted Aluminium Bottom foil 214 mm gm kg 37.728
03 LIC-077 Inner Carton of Raboz Tablet Tablet pc pcs 4120
04 LIS-055 Insert of Raboz Tablet pc pcs 4120
05 LPH-001 Printed Aluminium Pouch Foil of Raboz 20 Tablet pc pcs 20600
06 LMC-001 Master Carton General 420mmx330mmx260mm pc - pcs 53
07 LHG-001 Printed Aluminium Hologram pcs 8240

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Prepared by Checked by Approved by