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This document is a product data sheet for Novacal-D 50's Tablet produced by Leon Pharmaceuticals Limited. It provides information on the active and inactive ingredients, specifications, batch size, packaging materials, and approval signatures. The batch is 85.764 kg consisting of 60,000 tablets, each containing 1429 mg with calcium carbonate as the active ingredient. It lists 15 inactive ingredients, their quantities per tablet and per batch. It also lists packaging materials and their quantities per pack and per batch.

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395 views

Storage

This document is a product data sheet for Novacal-D 50's Tablet produced by Leon Pharmaceuticals Limited. It provides information on the active and inactive ingredients, specifications, batch size, packaging materials, and approval signatures. The batch is 85.764 kg consisting of 60,000 tablets, each containing 1429 mg with calcium carbonate as the active ingredient. It lists 15 inactive ingredients, their quantities per tablet and per batch. It also lists packaging materials and their quantities per pack and per batch.

Uploaded by

ShagorShagor
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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

______________ ________________ _____________


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

______________ ________________ _____________


Prepared by Checked by Approved by

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