DOSSIER NECESSARY FOR REGISTRATION IN BOLIVIAN MINISTRY

OF HEALTH
1. Pharmaceutical form and commercial presentation
Pharmaceutical form
Lyophilized powder for injection
A white or almost white loose mass or powder
Commercial presentation
10ml amber USP type II glass tubular vial, blue flip-off caps, adhesive
label,
10vials/box,100boxes/carton

2. Summary of drug information

Clinical particulars
Therapeutic indications
As an alternative to oral therapy for the following indications:
Adults
Treatment of duodenal ulcers
Prevention of relapse of duodenal ulcers
Treatment of gastric ulcers
Prevention of relapse of gastric ulcers
In combination with appropriate antibiotics, Helicobacter pylori (H.
pylori) eradication
in peptic ulcer disease
Treatment of NSAID..
Pharmacological properties
Pharmacodynamic properties
Pharmacotherapeutic group: Proton pump inhibitors
ATC code: A02BC01
Mechanism
Pharmaceutical particulars
List of excipients
Disodium edetate dihydrate
Sodium hydroxide
Incompatibilities

3. Formulation
Unit Dose
Active materials Per each vial
Omeprazole sodium eq to Omeprazole 40mg
Inactive materials Per each vial
EDTA-2Na 1.5mg
Batch formula Batch: 100, 000 vials
Active material X kg
In case of any change in Batch Size the quantity of each ingredient is
calculated using the
following formula:
Calculations:
To be calculated each time depending upon assay of Omeprazole as follows:
Quantity of Omeprazole 40mg.
Assay on as is batch = %A

4. Manufacturing process

4.1 Flow chart

Master manufacturing formula:
Batch size : 100,000 vials
Material mg/vial. Amounts Function
Omeprazole
sodium.
44.94mg * 4.6kg^ Active material
EDTA 2Na 1.5mg 0.154kg^ Inactive material
*Omeprazole sodium 44.94mg equivalent to omeprazole 40mg
^ Including 2.5% of average losing in the batch manufacturing process
Description and flow chart of the manufacturing process
All manufacturing steps comply with the GMP guidelines and are
performed in
accordance with the following instructions.
Step 1 Washing vials
Get rid of the outside packages

Methodology of analysis of the active

Method of analysis for Omeprazole sodium
State Standard
Characters
A white or almost white crystalline powder
Identification
(1) Dissolve a quantity in NaOH(0.1mol/L) to produce a solution of 20g per ml. Using
Ultraviolet
Spectrophotometry Method (Ch.P. 2005 Appendix IV A).The resulting solution exhibits
at 305nm
and 276 nm and the absorbance is 1.6~1.8

5. Technical specifications and Certificate of analysis (coa) of the raw

materials
6. Technical specifications and Certificate of analysis (coa) of the
finished Product
7. Specification of Packing Material
PACKAGING COMPONENT SPECIFICATION
PRODUCT NAME: OMEPRAZOLE FOR INJECTION
10 VIALS IN ONE BOX, 100 BOXES PACKED IN ONE CARTON
SR. NO. ITEMS PAGE
1. SPECIFICATION FOR 10ML TUBULAR VIALS 1, 2, 3 of 12
2. ADHESIVE LABEL 4, 5 of 12
3. BUTYL RUBBER STOPPER 6, 7 of 12
4. FLIP OFF CAP 8, 9 of 12
5. PRINTED INNER BOX 10 of 12
6. PRINTED OUTER CART.

8. Stability Studies
9. HPLC Spectrum of long term stability for 3 batches

10. Free Sales Certificate

11. Certificate of Pharmaceutical Product
12. Letter from the company to the Bolivian Ministry of Health authorizing
Tecnomed to commercialize product in Bolivia