DOSSIER FOR REGISTRATION OF FOREIGN DIEATARY

SUPPLEMENT IMPORTED TO CAMBODIA

 NAME AND ADDRESS OF THE APPLICANT

Name: WINCONSIN LINCOLN PHARMA CO., LTD

Address: Veo Hamlet, Dinh Trung Commune, Vinh Yen City, Vinh Phuc Province,
Vietnam
 NAME AND ADDRESS OF THE MANUFACTURER

Name: BAO NGUYEN PHARMACEUTICAL JOINT STOCK COMPANY

Address: Dong Van I Industrial Park, Dong Van Ward, Duy Tien Town, Ha Nam
Province, Vietnam
 NAME OF PRODUCT

CALCIUM CHOR
 COMPOSITION AND STRENGTH

Calcium glucoheptonnate 1100mg

Vitamin C 50mg

Vitamin PP 50mg

Vitamin D3 50IU

TO: DEPARTMENT OF DRUG AND FOOD

No.8 STREET UNG POKUN (109) – KHAN 7 MAKARA – PNOMPENH – CAMBODIA.
FAX: (855-23) 880247/ TEL: (855-23)88 02 47
 INDEX
I. ADMINISTRATION DOCUMENT
 APPLICATION FORM
 CERTIFICATION
 PRODUCT INFORMATION
 LABELING
II. TECHNICAL DOCUMENT
 UNIT FORMULA AND BATCH FORMULA
 MANUFACTURING PROCESS
 CONTROL PROCEDURE OF RAW MATERIALS
 CONTROL PROCEDURE OF FINISHED PRODUCT
 STORAGE CONDITION OF FINISHED PRODUCT ANS EXPIRED DATE
 APPLICATION FORM FOR MARKETING AUTHORIZATION
I. DETAIL OF APPLICANT AND MANUFACTURER
1. Applicant
Name: WINCONSIN LINCOLN PHARMA CO., LTD
Address: Veo Hamlet, Dinh Trung Commune, Vinh Yen City, Vinh Phuc Province, Vietnam
2. Manufacturer
Name: BAO NGUYEN PHARMACEUTICAL JOINT STOCK COMPANY
Address: Dong Van I Industrial Park, Dong Van Ward, Duy Tien Town, Ha Nam Province,
Vietnam
II. DETAIL OF PRODUCT
1. Product name
i. Commercial Name: CALCIUM Chor
ii. INN or Generic name:
2. Dosage form and Strength: Each 10ml contains:

Calcium glucoheptonnate 1100mg

Vitamin C 50mg

Vitamin PP 50mg

Vitamin D3 50IU

3. Product description: oral liquid with transparent light yellow color, sweet taste and
pleasant smell, packed in transparent plastic ampoules. Packed in transparent glass
ampoules.
4. Quantity of active ingredient(s) and excipients
 Active ingredient:
Calcium glucoheptonnate 1100mg

Vitamin C 50mg

Vitamin PP 50mg

Vitamin D3 50IU

 Inactive ingredient:
Excipients ……………..……………q.s 1 ampoule
 5. Indication, Dosage and Administration
i. Indication
Support health supplements, supplement calcium and, vitamin in daily meals.
ii. Dosage and Administration
Children: 1 ampoule per day, taken in the morning.
Adults: 1-2 ampoules per day, taken in the morning and at noon.
For drinking; by breaking one end of the ampoule, inverting and holding the tube
upright on the glass, and by bending the other end of the ampoule so that the medicine
can flow into the glas. Discard the tube after use.
6. Usage object
CALCIUM Chor is for teenagers who are in a period of strong growth, pregnant and
lactating women, people at risk of osteoporosis: Menopause, old age, thyroid disease,
sedentary life or long-term immobility .
7. Packing presentation
Box of 30 ampoules x 10ml.
8. Shelf-life:
36 months since manufacture date
III. ATTACHED INFORMATION
Free Sale Certificate in the country of Origin 

Manufacturing License 

Product Information 

Technical Documents 

Samples 

WINCONSIN LINCOLN PHARMA

CO.,LTD
Director

Nguyen Huy Hoang

 PRODUCT INFORMATION
CALCIUM CHOR (Ampoule)
1. TRADE NAME OF PRODUCT: CALCIUM CHOR
2. INTERNATIONAL NON-PROPRIETARY NAME:
3. COMPOSITION (ACTIVE INGREDIENT(S) AND EXCIPIENTS)
Each 10ml contains:
 Active ingredient
Calcium glucoheptonnate 1100mg

Vitamin C 50mg

Vitamin PP 50mg

Vitamin D3 50IU
 Inactive ingredient:
Excipients q.s……………..………………….……..…1 ampoule

4. INDICATION
Support health supplements, supplement calcium and, vitamin in daily meals.
5. USAGE OBJECT
CALCIUM CHOR is for teenagers who are in a period of strong growth, pregnant and
lactating women, people at risk of osteoporosis: Menopause, old age, thyroid disease,
sedentary life or long-term immobility .
6. DOSAGE AND ADMINISTRATION
Children: 1 ampoule per day, taken in the morning.
Adults: 1-2 ampoules per day, taken in the morning and at noon.
For drinking; by breaking one end of the ampoule, inverting and holding the tube
upright on the glass, and by bending the other end of the ampoule so that the medicine
can flow into the glas. Discard the tube after use.

7. DOSAGE FORM – PACKING SIZE

Box of 30 ampoules x 10ml
8. STORAGE
In dry and cool place (under 300C), protect from sun light, transfer handle with care.
9. SHELF LIFE
36 months since manufacture date
10. DISPENSATION
With prescription 
Without prescription 
11. REGISTRATION NUMBER:
12. MARKETING AUTHORIZATION HOLDER:

Name: WINCONSIN LINCOLN PHARMA CO., LTD

Address: Veo Hamlet, Dinh Trung Commune, Vinh Yen City, Vinh Phuc Province,
Vietnam
13. MANUFACTURER
Name: BAO NGUYEN PHARMACEUTICAL JOINT STOCK COMPANY
Address: Dong Van I Industrial Park, Dong Van Ward, Duy Tien Town, Ha Nam
Province, Vietnam

WINCONSIN LINCOLN PHARMA CO., LTD

Director

Nguyen Huy Hoang

 UNIT FORMULA AND BATCH FORMULA FOR MANUFACTURE

Name of Ingredient Unit Formula Batch formula Reference Standard

(for 10ml)
(1000l)

ACTIVE INGREDIENT

Calcium glucoheptonnate 1100mg 110000g USP 40

Vitamin C 50mg 5000g USP 40
Vitamin PP 50mg 5000g USP 40
Vitamin D3 50IU
INACTIVE INGREDIENT
Exipients q.s 10ml q.s 1000l Manufacturer’s

*Batch formula for 100 000 ampoules (equivalent to 1000 l)

 MANUFACTURE PROCESS

Health Supplement CALCIUM CHOR

STANDARD MATERIALS: TEST AND

WEIGH

GRINDING

RUB THROUGH SIEVE

DUAL MIX POWDER MATERIALS

DISSOLVE IN DISTILLED WATER

MIXING WELL

Test semi-finished
product

AMPOULE PACKING

Cleaned ampoule
Test finished
BOX PACKING product

ENTER INTO WAREHOUSE

 PRODUCTION PROCESS PRESENTATION
I. Manufacture process
1. Materials preparation
- All materials for production must be tested and meet requirements in
Pharmacopeias before used for manufacturing.
- All dispensing equipment must be cleaned.
- Blending room must be cleaned before blending.
- Plastic ampoule must be cleaned, dried before packing.
2. Dispensing
2.1. Input materials preparation
- Test all input materials following standard applied.
- Weigh all input materials according to formula.
2.2. Dispensing
- Standard-tested materials are entered into production process
- Grind all materials to fine powder
- Rub and sieve materials
- Mix powder mixture following dual mixing method
- Rub particle material through rubber
- Dissolve powder mixture of material above with distilled water enough. Mix well
until all materials dissolve completely.
- Semi-finished product test: test quality of medicinal liquid following applied
standard.
- Fill liquid into ampoules.
3. Packing in standard: 5 ampoules/blister, 2/3/4 blisters/box, each package provided with
the respective package leaflet
4. Print Batch No., expired date.
5. Test the finished product. If the quality meets all standards, enter warehouse.
1.1.
1.1.1.
1.1.2.
1.1.3.
1.1.4.
1.1.5.
1.1.6.
1.1.7.
1.1.8.
Send an average sample of finished product to Quality Control and keep the finished
products in quarantine until approval.
1.2.
II. In-process quality control
1. Control of raw materials:
 All ingredients and excipients must complies with standard applied for each as stated
before enter warehouse
2. Control during weighing:
 Check the cleanliness of the premise and relevant equipment.
 Check the name, label and amount weigh of the relevant raw materials as per written
instruction.
 Double check
3. Control during mixing
 Check and get line clearance before starting and after finishing process.
 Check and control mixing time as per Specification.
4. Control during:liquid dissolve and mixing
 Check and get line clearance before starting and after finishing process.
 Check and control mesh size, the dissolve of ingredient, the present of insolubility
substance, apprearance and flavor of medicinal liquid.
 Semi-finished product test: take sample to test the quality of medicinal liquid
following applied standard.
5. Control during ampoule packing:
 Check and get line clearance before starting and after finishing process.
 Check and control ampouleing machine setting and tool as per written instruction
(punches size, marks, pressure setting, filling depth, production rate)
 Check and control ampouleing process as per written instruction (ampoule
Appearance, foreign matter, thickness, hardness and disintegration, friability, weight,
weight variation).
6. Control during packaging:
 Check and get line clearance before starting and after finishing process.
 Check the packaging materials as per Specifications
 Check the control packed contents as per Specification.
 1. CONTROL PROCEDURE OF RAW MATERIAL

Name of Ingredient Reference Standard

Calcium glucoheptonnate USP 40
Vitamin C USP 40
Vitamin PP USP 40
Vitamin D3 USP 40
 CONTROL PROCEDURE OF FINISHED PRODUCT
I. Quality of finished product
1. Characteristics: oral liquid with transparent light yellow color, sweet taste and
pleasant smell, packed in transparent glass ampoules.
2. Density: 1.05 – 1.45
3. Assay of active ingredient:

No Ingredient Limit of stated amount

1 Calcium glucoheptonnate 240mg – 360mg/10ml

4. Limit of microorganism
No Criteria Limit

1 Total aerobic microbial count No more than 104CFU/ml

2 Total yeast and moulds No more than 102 colonies/ml

3 Staphylococus aureus Not allowed

4 Escherichia Ecoli No more than 3 CFU/ml

5 Coliforms No more than 10 CFU/ml

5. Limit of heavy metal

No Criteria Limit

1 Cadmium 1 ppm

2 Pb 3 ppm

3 Hg 0.1 ppm
 ANALYSIS OF FINISHED PRODUCT: CALCIUM CHOR
Characteristic: By visual observation, the product complies with appearance requirements.
Density: Take out the liquid inside the ampoule, weight precisely to have mass and volume
of medicinal liquid inside the ampoule. Calculate the density of liquid based on formula
Density= Mass/Volume
Acceptance range: 1.05 – 1.45
Assay:

Calcium glucoheptonnate: As per Ref. USP 40 - Calcium glucoheptonnate

Microbiological test:
Preparation and sample dilution:
 All operations performed in sterilized condition to avoid contamination.
 Balance and homogenization of 10ml of the substance to be examined in 90ml of
buffer solution p.H 7.0, dilution 1:10.
 Dilute 1ml the solution 1:10 in 9ml of buffer solution pH 7.0, dilution 1:100
 Futher diluted if necessary.

Total viable aerobic count: Determined by plate count.

 To 1ml of each dilution into 2 petri dishes, 1ml per petri dish.
 Add 15 to 20ml Casein Soybean Agar, rotating light box to mix with the composition
environment, stand at room temperature for freezing.
 Overturn box and incubate at 350C for 72 hours. Read and record results every 24
hours.
 Choose the petri dish of a dilute concentration of 25 to 250 CFU in 1 dish to count
calculate the results.
 Total aerobic bacteria in 1 gram of of the substance = the average number of CFU x
corresponding dilute concentrations.
Mold and Yeast:
 Proceed as counting the total number of aerobic bacteria but rather by environment
Sabouraud agar.
 Incubated at 200C to 250C for 7 days.

Escherichia coli and coliform:

 Carry out on 2 petrifilm dishes
 Place the petrifilm dish on a flat surface, pulled the film above on.
 Using a pipette to straight 1 ml diluted 1:10 into the disk, fixed disk form in the
middle.
  Scroll film above plate down carefully, to avoid creating air bubbles. Not to plate
falling film.
 Place the pieces scattered on the membrane in the implanted sample. Gently on spread
pattern on pieces before gel formation, avoid rotating on sliding piece of sample
spread.
 Incubated at 350C for 24 hours for Coliform: Red colonies with gas bubble around.
 Incubated at 350C for 48 hours for Escherichia Coli: Blue green to red colonies, often
accompanied by gas bubbles.
Calculate result:
 Number of CFU Escherichia coli in 1 gram of substance = total of CFU Escherichia
coli on 2 dishes x 5
 Number of CFU Coliform in 1 gram of the substance = total of CFU Coliform on 2
dishes x 5.
Staphylococcus aureus:
 Fruit 2ml diluted 1:10 on 5 dishes MSA (Mannitol salt agar), each 0.4 ml, incubate at
350C for 24 to 48 hours.
 Samples with Staphylococcus aureus if any:
 Yellow colonies with yellow zones surrounding light.
 Gram stain: gram – positive bacteria forms a bunch of grapes.
 Coagulase – positive reactions.
 Coagulase reaction:
 Using implants to take at least two suspect colonies from MSA, medium to
tubes containing 0.5ml of serum mammals. Incubate at 370C for 24 hours.
Observations every 3 hours.
 Positive when the plasma was frozen at any level.
 Count the number of colonies meet the above properties in each dish.
 Number of CFU Staphylococcus aureus in 1g = total number of colonies in 5 dishes x
5.
Limit of heavy metal: Determined by Ref. USP 40 – 231- Heavy metal
 STORAGE CONDITION OF FINISHED PRODUCT AND EXPIRED DATE

1. Storage: Dry and cool place (below 300C), protect from light and moisture.
2. Expired date: 36 months since manufacture date
3. Stability research for expired date
 STABILITY TEST REPORT

1. Protocol
 Name of product: CALCIUM Chor Ampoule
 Batch No.: 07035NN
 Storage condition: 30 ± 20/75 ± 5% RH
 Shelf-life: 3 years
2. Testing method:
Criteria When test are Test method Criteria
done
Appearance Finished product Inspect with Oral liquid with
visualization transparent light yellow
color, sweet taste and
pleasant smell, packed in
transparent plastic
ampoules.
Density Finished product As per analytical 1.05-1.45
method – Control of
finished product
Assay: Finished product Test performed as per As required
in house specification
Calcium
and analytical
glucoheptonnate
method – Control of
finished product
Limit of Finished product Test performed as per As required
microbiological in house specification
and analytical
method – Control of
finished product
Heavy metal Finished product Test performed as per As required
in house specification
and analytical
method – Control of
finished product

3. Result of test
Time Criteria Results
Initial Appearance Passed
Density Passed
 Assay
Calcium glucoheptonnate 321.95mg

Limit of microbiological Passed

Heavy metal Passed

3 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 321.79mg

Limit of microbiological Passed

Heavy metal Passed

9 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 321.64mg

Limit of microbiological Passed

Heavy metal Passed

12 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 321.52mg

Limit of microbiological Passed

Heavy metal Passed

18 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 321.44mg

Limit of microbiological Passed

Heavy metal Passed

24 months Appearance Passed

Density Passed
 Assay
Calcium glucoheptonnate 321.35mg

Limit of microbiological Passed

Heavy metal Passed

30 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 321.27mg

Limit of microbiological Passed

Heavy metal Passed

36 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 320.93mg

Limit of microbiological Passed

Heavy metal Passed

4. Conclusion
The stability of CALCIUM Chor Ampoule had been tested over 36 months at 30 ± 2 0C and
humidity 75 ± 5% RH. The result of test shows that the stability of CALCIUM Chor can be
guaranteed for 3 years in above storage conditions.
QA Manager

Nguyen Duc Anh

 STABILITY TEST REPORT
1. Protocol
 Name of product: CALCIUM CHOR Ampoule
 Batch No.: 07036NN
 Storage condition: 30 ± 20/75 ± 5% RH
 Shelf-life: 3 years
2. Testing method;
Criteria When test are Test method Criteria
done
Appearance Finished product Inspect with Oral liquid with
visualization transparent light yellow
color, sweet taste and
pleasant smell, packed in
transparent glass
ampoules.
Density Finished product As per analytical 1.05-1.45
method – Control of
finished product
Assay: Finished product Test performed as per As required
in house specification
Calcium
and analytical
glucoheptonnate
method – Control of
finished product
Limit of Finished product Test performed as per As required
microbiological in house specification
and analytical
method – Control of
finished product
Heavy metal Finished product Test performed as per As required
in house specification
and analytical
method – Control of
finished product

3. Result of test
Time Criteria Results
Initial Appearance Passed
Density Passed
 Assay
Calcium glucoheptonnate 320.86mg

Limit of microbiological Passed

Heavy metal Passed

3 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 320.78mg

Limit of microbiological Passed

Heavy metal Passed

9 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 320.73mg

Limit of microbiological Passed

Heavy metal Passed

12 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 320.71mg

Limit of microbiological Passed

Heavy metal Passed

18 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 320.67mg

Limit of microbiological Passed

Heavy metal Passed

24 months Appearance Passed

Density Passed
 Assay
Calcium glucoheptonnate 320.62mg

Limit of microbiological Passed

Heavy metal Passed

30 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 320.58mg

Limit of microbiological Passed

Heavy metal Passed

36 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 320.51mg

Limit of microbiological Passed

Heavy metal Passed

4. Conclusion
The stability of CALCIUM CHOR ampoule had been tested over 36 months at 30 ± 2 0C and
humidity 75 ± 5% RH. The result of test shows that the stability of CALCIUM CHOR can be
guaranteed for 3 years in above storage conditions.
QA Manager

Nguyen Duc Anh

 STABILITY TEST REPORT
1. Protocol
 Name of product: CALCIUM CHOR Ampoule
 Batch No.: 07037NN
 Storage condition: 30 ± 20/75 ± 5% RH
 Shelf-life: 3 years
2. Testing method:
Criteria When test are Test method Criteria
done
Appearance Finished product Inspect with Oral liquid with
visualization transparent light yellow
color, sweet taste and
pleasant smell, packed in
transparent glass
ampoules.
Density Finished product As per analytical 1.05-1.45
method – Control of
finished product
Assay: Finished product Test performed as per As required
in house specification
Calcium
and analytical
glucoheptonnate
method – Control of
finished product
Limit of Finished product Test performed as per As required
microbiological in house specification
and analytical
method – Control of
finished product
Heavy metal Finished product Test performed as per As required
in house specification
and analytical
method – Control of
finished product

3. Result of test
Time Criteria Results
Initial Appearance Passed
Density Passed
Assay
 Calcium glucoheptonnate 320.51mg
Limit of microbiological Passed
Heavy metal Passed
3 months Appearance Passed
Density Passed
Assay
Calcium glucoheptonnate 320.47mg

Limit of microbiological Passed

Heavy metal Passed

9 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 320.42mg

Limit of microbiological Passed

Heavy metal Passed

12 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 320.46mg

Limit of microbiological Passed

Heavy metal Passed

18 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 320.48mg

Limit of microbiological Passed

Heavy metal Passed

24 months Appearance Passed

Density Passed
Assay
 Calcium glucoheptonnate 320.44mg
Limit of microbiological Passed
Heavy metal Passed
30 months Appearance Passed
Density Passed
Assay
Calcium glucoheptonnate 320.32mg

Limit of microbiological Passed

Heavy metal Passed

36 months Appearance Passed

Density Passed
Assay
Calcium glucoheptonnate 320.27mg

Limit of microbiological Passed

Heavy metal Passed

4. Conclusion
The stability of CALCIUM Chor Ampoule had been tested over 36 months at 30 ± 2 0C and
humidity 75 ± 5% RH. The result of test shows that the stability of CALCIUM Chor can be
guaranteed for 3 years in above storage conditions.
QA Manager

Nguyen Duc Anh

PRODUCT INFORMATION
CERTIFICATION
APPLICATION FORM