Email Worksheet

The application form has six parts: 1) General

Information, 2) Establishment Information, 3) Product SUBJECT: Milaor Trading Corporation#V
Information, 4) Supporting Information, 5) Sources and
Clients, and 6) Applicant Information. In the worksheet
'Form' (with the red tab) you will see a dashboard
where the different parts are identified. If the part is
appropriately filled up, a green 'PROCEED' will be BEGIN:LTO;CFRR;Milaor Trading
indicated.Required fields will appear sequentially.To BODY: Corporation#V#Wholesaler#0;INT#0#0#0#0#
minimize errors and confusion, it is recommended that 0#0#0#0#0;8000;80;0;8080:END
a blank form be used for every application. If the form is
appropriately filled up, the composed body text (in the
green box) will appear.
Be careful to paste the body text completely as text
(not as an image or as an attachment). DON'T attach
any file to the email request. Printing Instructions
(Please print the following parts of the worksheet 'Form
For Drug Registration (excluding amendmen
For Non-Drug Registration (excluding amendmen
For Licensing (exclusing amendmen
For A

Application Process Overview

 IMPORTANT
ation#V

READ THIS PAGE CAREFULLY.

Provide information only
or Trading when asked for.
saler#0;INT#0#0#0#0#
8080:END

of the worksheet 'Form' if applicable)

on (excluding amendments and compliances): pages 1 and 4.
on (excluding amendments and compliances): pages 1 and 3.
ng (exclusing amendments and compliances): pages 1 and 2.
For All Other Applications: page 1 only.
 APPLICATION FORM 51SOURCES & CLIENTS Add Source 2 Add
PROCEED
Client
This is the application form. Without the 5.1.1 Type of Establishment: Processor 5.2.1 Type of Establishment: Trader
appropriate petition or declaration form, this
application may be rejected. 5.1.2 Name of Nestle Philippines Inc. 5.2.2 Name of New Sipocot Drug
Source Client
Document Tracking Number APPLICATION FORM STATUS
GENERAL INFORMATION: PROCEED 5.1.3 Office Brgy. Niguan, Cabuyao, Laguna 5.2.3 Office San Juan Avenue, Brgy. South Centro,
ESTABLISHMENT INFORMATION: PROCEED Address Address Sipocot, Camarines Sur
Description (Optional): PRODUCT INFORMATION: PROCEED LTO-
SUPPORTING INFORMATION: PROCEED 5.1.4 Local FDA License Number: 30000009331
000-421-786-
5.2.4 Local FDA License Number: cdrr-rv-ds-358
1 GENERAL INFORMATION PROCEED SOURCES & CLIENTS: PROCEED 5.1.5 Tax Identification Number: 16
000 5.2.5 Tax Identification Number: 192-864-357
1.1 Product Center: Food
APPLICANT INFORMATION: PROCEED 5.1.6 Contact Detail 1 Landline: 049-5450123 5.2.6 Contact Detail 1 Mobile: 9998888280
ORDER OF PAYMENT 5.1.7 Contact Detail 2 Landline: 02-7563001 5.2.7 Contact Detail 2 Mobile: 9195311278
Amount Due: Php 8,080.00
1.2 Authorization: License to Operate
Fee : Php 8,000.00 3 Add Client 4 None
Legal Research Fee : Php 80.00 5.3.1 Type of Establishment: Trader
1.3 Type: Initial
Surcharge : Php -
5.3.2 Name of Kaezar Drugs
OR Number :
1.4 Primary Activity: Wholesaler Client
Date Paid:
Computation Valid Until: 30 December, 1899
5.3.3 Office San Juan Avenue, Brgy. South Centro,
This form was last edited on 13 October 2016, 10:28 AM.
Address Sipocot, Camarines Sur
4 SUPPORTING INFORMATION Add or
PROCEED Delete? 5.3.4 Local FDA License Number: cdrr-rv-ds-476
PROCEED 5.3.5 Tax Identification Number: 180-286-237
5.3.6 Contact Detail 1 Mobile: 9216178577
5.3.7 Contact Detail 2 Mobile: 9162212503

PROCEED

PROCEED

2 ESTABLISHMENT INFORMATION PROCEED

2.1 Name of Establishment
Milaor Trading Corporation

2.3 Tax Identification Number: 000-269-856

2.4 Office Address 2.5.1 Region: V
MTC Compound, San Jose, Milaor, Camarines Sur
2.5 Warehouse Address 2.6.1 Region: V
MTC Compound, San Jose, Milaor, Camarines Sur
6 APPLICANT INFORMATION PROCEED

The undersigned attest to have provided true and complete information in this form, and to provide complete
requirements at the time of submission. The undersigned agree to strict compliance with the rules and regulations of
2.7.0 E-mail Address: [email protected] the Food and Drug Administration (FDA), including Good Manufacturing Practice (GMP), Good Distribution and Storage
2.7.1 Contact Detail 1 Landline: 473-6489 Practice (GDSP), Good Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). Further, the undersigned agree
to grant authority to the FDA to verify the truthfulness of the information provided with this application.
2.7.2 Contact Detail 2 Landline: 4736491
2.7.3 Contact Detail 3 Fax: 472-6489 loc 122
6.1 APPROVING AUTHORITY
Signature 6.1.5 Mailing Address
MTC Compound, San Jose, Milaor,
PROCEED Camarines Sur

6.1.1.0 Family
Latest photo of applicant
Name: Tan
6.1.1.1 First
Dennis
Name(s): 6.1.6.0 E-mail Address:
6.1.1.2 Middle [email protected]
Co
Name: 6.1.6.1 Contact Detail 1
6.1.2 Designation: Owner/ General Manager/ President Landline: 4726489
6.1.3 Tax ID Number: 102098276 6.1.6.2 Contact Detail 2
6.1.4.0 Type of Gov't ID: Land Transportation Office (Driver's) Landline: 4736491
6.1.4.1 ID Number: N0388056874 6.1.6.3 Contact Detail 3
6.1.4.2 Date Expiry: 27-Aug-22 Fax: 472-6489 loc 122
6.2 APPLICANT
Signature 6.2.5 Mailing Address
Block 22, Lot 6, 3rd St. Extension,
Progress Homes Phase 1, Brgy. San
Vicente, Canaman, Camarines Sur
PROCEED 6.2.2.0 Family
Latest photo of applicant
Name: Dulpina
6.2.2.1 First
Reynaldo
Name(s): 6.2.6.0 E-mail Address:
6.2.2.2 Middle [email protected]
Diamsin
Name: 6.2.6.1 Contact Detail 1
6.2.2 Designation: Authorized Representative Mobile: #FMT
6.2.3 Tax ID Number: 190-668-292 6.2.6.2 Contact Detail 2
6.2.4.0 Type of Gov't ID: Land Transportation Office (Driver's) Landline: 4726489
6.2.4.1 ID Number: E-0501020276 6.2.6.3 Contact Detail 3
6.2.4.2 Date Expiry: 30-Dec-18 Fax: 472-6489 loc 122
License to Operate

This is the petition form for establishment licensing by the Food and Drug Administration of the Philippines.
 PETITION
We categorically declare that all data and information submitted in connection with this application as well as other submissions in the future including
amendments, are true, correct, and reflect the total information available.
I/we am/are duly authorized to affirm the following declaration on behalf of the Company: Milaor Trading Corporation

I. The said establishment shall be open for business hours under the supervision of a PRC registered professional (if applicable) or authorized personnel;

II. The pharmacist and other allied health professionals, upon and during employment in this establishment, is/are not and will not in any way be connected with any
other FDA-regulated establishment (if applicable);

III. The approved and valid License to Operate shall be displayed in a conspicuous place of the establishment;

IV. To change the business name of the establishment and/or brand name of products in the event that there is a similar or same name registered with the Food and
Drug Administration, or if the FDA rules later that it is misleading;

V. The attached electronic copy of files/documents/information of the LTO application are the exact duplicate of the hard copy and, any discrepancy, prejudicial
contents or willful misrepresentation on any of the data therein shall be a ground for disapproval of application and/or the filing of legal action against the
undersigned and/or the company;

VI. If applying for automatic renewal:

a. Have filed the application, and have paid the complete & appropriate renewal fee before expiry date;

B. That there are no changes or variations in the establishment since the last renewal of LTO specifically but not limited to change of location, change of
ownership, change of business name, change of registered pharmacist, change in warehouse site, additional supplier and product lines, change in activity, change
in key personnel;

VII. The products we manufacture, distribute and/or sell are registered or to be registered with FDA prior to distribution or sale, and that we assume primary
responsibility and/or stewardship over the product in case of liability, adverse events, and/or other public health & safety issues;

VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by FDA’s authorized representatives at any reasonable time
and undertake to respond and cooperate fully with the FDA with regard to any subsequent post-marketing activity;

IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the change in business address, business name, ownership, or any other
circumstances in relation to the approval of this application is a ground for revocation of the License to Operate;

X. Any violation of the above provisions and rules and regulations will automatically be subject to the SUSPENSION/ CANCELLATION/ REVOCATION of the License to
Operate.

XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720, as amended by Republic Act no. 9711, otherwise known as the Food and
Drug Administration Act of 2009, other allied laws and their implementing rules and regulations.

WHEREFORE, the undersigned confirm the truth of our declaration and awareness of the foregoing duties and responsibilities among others, and prays that this
application for License to Operate be granted after compliance with the Food and Drug Administration’s requirements.

WAIVER
I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATION TO VERIFY THROUGH BOTH GOVERNMENT AND PRIVATE
RESOURCES THE AUTHENTICITY OF ALL THE INFORMATION AND DOCUMENTS SUBMITTED .

ACKNOWLEDGEMENT
SUBSCRIBED AND SWORN TO BEFORE ME this _______ day of _________________ 20________ at ______________________________

_______________________________________________________, Philippines, personally appeared the following :

Name and Signature Identification Number Expiry Date of ID Place Issued

Land Transportation Office

(Driver's):N0388056874 27-Aug-22
1) Dennis Co Tan ______________________________
Land Transportation Office 30-Dec-18
(Driver's):E-0501020276
2) Reynaldo Diamsin Dulpina ______________________________
Known to me and to me known to be the same persons who execute the application form and this petition form, and they acknowledged to me that the same is
their free and voluntary act and deed. WITNESS MY HAND AND SEAL on the date and place first above written.

Doc. No. : _____________________________

Page No. : ____________________________
Book No. : ____________________________
Series of : _____________________________
 Provide in this space a description of the
Off-white to beige, semi biconvex film- product in terms of rheology, thermal, and Use this space to explain how the lot code
geometry properties among others, as
CLOPIDOGREL (as BISULFATE) coated tablet with score on one side and used on the product label is correctly
applicable; Indicate if appropriate
plain on the other side microbiological cultures present in the interpreted
product
CLOPIDOGREL (AS BISULFATE) NINBO BEITONG IMP. & EXP. CO. LTD., INDIA KAMAGONG CHEMTRADE CORP./SAN PEDRO LAGUNA
2) Active Pharmaceutical Ingredient; 2) API Manufacturer, Address Address Address; 2) API Supplier, Address Address Address;
3) Active Pharmaceutical Ingredient; 3) API Manufacturer, Address Address Address; 3) API Supplier, Address Address Address;
4) Active Pharmaceutical Ingredient; 4) API Manufacturer, Address Address Address; 4) API Supplier, Address Address Address;
5) Active Pharmaceutical Ingredient; 5) API Manufacturer, Address Address Address; 5) API Supplier, Address Address Address;
6) Active Pharmaceutical Ingredient; 6) API Manufacturer, Address Address Address; 6) API Supplier, Address Address Address;
7) Active Pharmaceutical Ingredient; 7) API Manufacturer, Address Address Address; 7) API Supplier, Address Address Address;
8) Active Pharmaceutical Ingredient; 8) API Manufacturer, Address Address Address; 8) API Supplier, Address Address Address;
9) Active Pharmaceutical Ingredient; 9) API Manufacturer, Address Address Address; 9) API Supplier, Address Address Address;
10) Active Pharmaceutical Ingredient; 10) API Manufacturer, Address Address Address; 10) API Supplier, Address Address Address;
11) Active Pharmaceutical Ingredient; 11) API Manufacturer, Address Address Address; 11) API Supplier, Address Address Address;
12) Active Pharmaceutical Ingredient; 12) API Manufacturer, Address Address Address; 12) API Supplier, Address Address Address;
 Department of Health
Food and Drug Administration
APPLICATION FORM STATUS: APPLICATION FORM
4 SUPPORTING INFORMATION
1
GENERAL INFORMATION: PRO 1 1 0 0 0 0 0 SOURCES & CLIENTS: PRO 1 1 Add or Del 0 1
ESTABLISHMENT INFORMATION: PRO 1 0 0 1 1 Document Tracking Number 1 PR1
OC
PRODUCT INFORMATION: PRO 1 0 0 0 1 0 0 1 EE1
SUPPORTING INFORMATION: PRO 1 0 1 1 1 1 0 1 1 PRO 1 1D
APPLICANT INFORMATION: PRO 1 1 1 1 Description (Optional):
PAYMENT INFORMATION: 1 0 0
GENERAL INFORMATION 2 ESTABLISHMENT INFORMATION 1 1

1.1 Product Center: Food 1.4 Primary Activity: Wholesaler

2.1 Name of Establishment 1 1
1.2 Authorization: License to Operate
Milaor Trading Corporation
1.3 Type: Initial 1 1 1
2.3 Tax Identification Number: 000-269-856
2.4 Office Address 2.5.1 RegioV
1 1
0 MTC Compound, San Jose, Milaor, Camarines Sur
30-Dec-1899 2.5 Warehouse Address 2.6.1 RegioV
1 1
MTC Compound, San Jose, Milaor, Camarines Sur
1
0 1 1
30-Dec-1899 1
2.7.0 E-mail Address: [email protected]
2.7.1 Contact Detail 1 Landline: 473-6489 1 1
0 2.7.2 Contact Detail 2 Landline: 4736491
0 0 2.7.3 Contact Detail 3 Fax: 472-6489 loc 122
1 1
1

0 1 1 1
0 PR
OC
1 1 EE1
Drug 1 0 HUHS 1 1D
0 0 Food 0 Device 1 1
1 1
1 1 PR1
OC
1 EE1
0 1 1 1D
0 0
1 Add Source 2 Add Client
5.1.1 Type of Establishment: Processor 5.2.1 Type of Establishment: Trader

0 0
0 5.1.2 Name of SouNestle Philippines Inc. 5.2.2 Name of Cli New Sipocot Drug
1 0
1
1 1 0 5.1.3 Office AddreBrgy. Niguan, Cabuyao, Laguna 5.2.3 Office AddreSan Juan Avenue, Brgy. South Centro, Sipocot,
Type of Amendment: Other Amendments 1 0 5.1.4 Local FDA License Number: LTO-3000000933116 5.2.4 Local FDA License Number: cdrr-rv-ds-358
Source: Add/ Delete FAL 0 License to Operate TRU 1 0 5.1.5 Tax Identification Number: 000-421-786-000 5.2.5 Tax Identification Number: 192-864-357
Source: Change of B FAL 0 Reclassification FAL 0 0 5.1.6 Contact Detail 1 Landline: 049-5450123 5.2.6 Contact Detail 1 Mobile: 9998888280
Change of Importer/ DFAL 0 0 Change of DistributorFAL 0 1 0 5.1.7 Contact Detail 2 Landline: 02-7563001 1 5.2.7 Contact Detail 2 Mobile: 9195311278 1
Product Registration FAL
License to Operate TRU
0
1
Finished Product
Raw Material
FAL
FAL
0
0
Php -
3 Add Client 4 None 0
1 Free Sale, Certificate FAL 0 1 5.3.1 Type of Establishment: Trader 1
Pharmaceutical Produc FAL 0
Export Certificate FAL 0 1
Additional ProductionFAL 0 1 1 5.3.2 Name of Cli Kaezar Drugs 1
ORDER OF PAYMENT 1
Amount Due: 8080
Fee : 8000 5.3.3 Office AddreSan Juan Avenue, Brgy. South Centro, Sipocot, 1
Legal Research Fee : 80 5.3.4 Local FDA License Number: cdrr-rv-ds-476 1
Surcharge : 0 5.3.5 Tax Identification Number: 180-286-237 1
OR Number : 5.3.6 Contact Detail 1 Mobile: 9216178577 0 1
Date Paid: This is the application form. Without the appropriate petition 5.3.7 Contact Detail 2 Mobile: 9162212503 1 01 1
Computation Valid Until: 0 or declaration form, this application may be rejected.
None 0 None 0
6 APPLICANT INFORMATION
1 1

The undersigned attest to have provided true and complete information in this form, and to provide complete requirements
at the time of submission. The undersigned agree to strict compliance with the rules and regulations of the Food and Drug 1 1
Administration (FDA), including Good Manufacturing Practice (GMP), Good Distribution and Storage Practice (GDSP), Good
Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). Further, the undersigned agree to grant authority to the
FDA to verify the truthfulness of the information provided with this application.

6.1 APPROVING AUTHORITY

6.1.5 Mailing Address 1 1
1 1
1 1
Signature 0 1 0 1
01 1 01 1
6.1.1.0 Family Na Tan
None 0 None 0
MTC Compound, San Jose, Milaor, Camarin
6.1.1.1 First NameDennis 6.1.6.0 E-mail Address: 1 1
[email protected]
Latest photo of applicant 6.1.1.2 Middle NaCo 6.1.6.1 Contact Detail 1
6.1.2 Designation: Owner/ General Manager/ President Landline: 4726489 1 1
6.1.3 Tax ID Number: 102098276 6.1.6.2 Contact Detail 2
6.1.4.0 Type of Gov't ID: Land Transportation Office (Driver's) Landline: 4736491
6.1.4.1 ID Number: N0388056874 6.1.6.3 Contact Detail 3 1 1
6.1.4.2 Date Expiry: 44800 Fax: 472-6489 loc 122 1 1
6.2 APPLICANT 1 1
6.2.5 Mailing Address 0 1 0 1
01 1 01 1
None 0 None 0
Signature
1 1
6.2.2.0 Family Na Dulpina
Block 22, Lot 6, 3rd St. Extension, Progre
6.2.2.1 First NameReynaldo 6.2.6.0 E-mail Address: 1 1
[email protected]
Latest photo of applicant 6.2.2.2 Middle NaDiamsin 6.2.6.1 Contact Detail 1
6.2.2 Designation: Authorized Representative Mobile: 9988415916 1 1
6.2.3 Tax ID Number: 190-668-292 6.2.6.2 Contact Detail 2 1 1
6.2.4.0 Type of Gov't ID: Land Transportation Office (Driver's) Landline: 4726489 1 1
6.2.4.1 ID Number: E-0501020276 6.2.6.3 Contact Detail 3 0 1 0 1
6.2.4.2 Date Expiry: 43464 Fax: 472-6489 loc 122 01 1 01 1

Page 7 of 14 661715736.xlsx 05/02/2023 06:18:46

 Department of Health
Food and Drug Administration
License to Operate APPLICATION FORM
This form is the second page of a two-page application form for licensing by the Food and Drug Administration of the Philippines.

PETITION

I/we am/are duly authorized to affirm the following declaration on behalf of the Company:

I. The said establishment shall be open for business hours under the supervision of PRC registered professional (if applicable) or authorized personnel;

II. The pharmacist and other allied health professionals, upon and during employment in this establishment, is/are not and will not in any way be connected with any other FDA regulated establishment (if applicable);

III. The approved and valid License to Operate shall be displayed in a conspicuous place of the establishment;

IV. To change the business name of the establishment in the event that there is a similar or same name registered with the Food and Drug Administration or if it rules later that it is misleading;

V. The attached electronic copy of files/documents/information of the LTO application are the exact duplicate of the hard copy and, any discrepancy/ prejudicial contents or wilful misrepresentation on any of the data therein shall be a ground for disapprov

VI. If applying for automatic renewal:

a. Have filed the application before expiry date;

b. Have paid the renewal fee prior its expiry date;

c. That there are no unapproved changes or variations whatsoever in the establishment since the last renewal of LTO specifically but not limited to change of location, change of ownership, change of business name, change of registered pharmacist, cha

VII. The products we manufacture, distribute or sell are registered or to be registered with FDA prior to distribiution or selling;

VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by FDA’s authorized representatives at any reasonable time and undertake to respond and cooperate fully with the FDA with regard to any subsequent p

IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the change in business address, business name, ownership, or any other circumstances in relation to the approval of this application is a ground for delisting of the Licen

X. Any violation of the above provisions and rules and regulations will automatically be subject to the SUSPENSION/ CANCELLATION/ REVOCATION of the License to Operate.

XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720, as amended by Republic Act no. 9711, otherwise known as the Food and Drug Administration Act of 2009, other allied laws and their implementing rules and regul

WHEREFORE, the undersigned confirm the truth of our declaration and awareness of the foregoing duties and responsibilities among others, and prays that this application for License to Operate be granted after compliance with the Food and Drug Admini

WAIVER

I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATION TO VERIFY THE AUTHENTICITY OF ALL THE DOCUMENTS SUBMITTED FROM BOTH GOVERNMENT AND PRIVATE RESOURCES.

ACKNOWLEDGEMENT

SUBSCRIBED AND SWORN TO BEFORE ME this _______ day of _________________ 20________ at ______________________________

_______________________________________________________, Philippines, personally appeared the following :

Name and Signature Identification Number Date Issued Place Issued

1) Tan Dennis _________________________ ___________ ______________________________

2) _________________________ ___________ ______________________________

Known to me and to me known to be the same persons who execute the foregoing instrument consisting of 2 pages including the application form, and they acknowledged to me that the same is their free and voluntary act and deed. WITNESS MY HAND

Doc. No. : _____________________________

Page No. : ____________________________

Book No. : ____________________________

Series of : _____________________________

Page 8 of 14 661715736.xlsx 05/02/2023 06:18:46

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 9 of 14 661715736.xlsx 05/02/2023 06:18:46

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 10 of 14 661715736.xlsx 05/02/2023 06:18:46

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