Email Worksheet
The application form has six parts: 1) General
Information, 2) Establishment Information, 3) Product
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
indicated.Required fields will appear sequentially.To
minimize errors and confusion, it is recommended that
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.
Application Process Overview
SUBJECT: Mediserv Pharmaceuticals#NCR
BEGIN:CPR;CDRR;Mediserv
Pharmaceuticals#NCR#Importer#873512345
;INT#0#Human Drug,
BODY:
Unbranded#0#Losartan potassium 100mg
film-coated
tablet#1#0#0#0#0;4000;40;0;4040:END
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 Al
 IMPORTANT
ticals#NCR

READ THIS PAGE CAREFULLY.

iserv Provide information only
#Importer#873512345 when asked for.
n potassium 100mg

00;40;0;4040: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 5 SOURCES & CLIENTS
1 Add Source 2 None
PROCEED

This is the application form. Without the 5.1.1 Type of Establishment: Wholesaler
appropriate petition or declaration form, this
application may be rejected. 5.1.2 Name of Aurobindo Pharma - Milpharm Ltd.
Source
Document Tracking Number APPLICATION FORM STATUS
GENERAL INFORMATION: PROCEED 5.1.3 Office Odyssey Business Park, Ares Block, West
ESTABLISHMENT INFORMATION: PROCEED End Road, South Ruislip, Middlesex, HA4
Address 6QD
Description (Optional): PRODUCT INFORMATION: PROCEED
SUPPORTING INFORMATION: PROCEED 5.1.4 Local FDA License Number: PL 16363/0422
1 GENERAL INFORMATION PROCEED SOURCES & CLIENTS: PROCEED 5.1.5 Tax Identification Number: 4200021
1.1 Product Center: Drug
APPLICANT INFORMATION: PROCEED 5.1.6 Contact Detail 1 Landline: (0)208 845 8811
ORDER OF PAYMENT 5.1.7 Contact Detail 2 Fax: (0)208 845 8795
1.2 Authorization: Product Registration
Amount Due: Php 4,040.00
Fee : Php 4,000.00
Legal Research Fee : Php 40.00
1.3 Type: Initial
Surcharge : Php -
OR Number :
1.4 Primary Activity: Importer
Date Paid:
Computation Valid Until: 30 December, 1899
This form was last edited on 13 October 2016, 10:28 AM.
1.5 Current License 873512345 4 SUPPORTING INFORMATION
Number: PROCEED
1.5.1 Expiry Date: 15-Aug-24 PROCEED
Your License will expire in 706 days.

PROCEED

PROCEED

2 ESTABLISHMENT INFORMATION PROCEED

2.1 Name of Establishment
Mediserv Pharmaceuticals

2.3 Tax Identification Number: 12345678

2.4 Office Address 2.5.1 Region: NCR
EDSA corner North Ave, Barangay Bagong Pag-asa
2.5 Warehouse Address 2.6.1 Region: III
RV9J+5HQ
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 the
2.7.0 E-mail Address: bsphcorp@gmail.com Food and Drug Administration (FDA), including Good Manufacturing Practice (GMP), Good Distribution and Storage
2.7.1 Contact Detail 1 Landline: 79764647 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 Mobile: 9094453321
2.7.3 Contact Detail 3 Fax: N/A
6.1 APPROVING AUTHORITY
Signature 6.1.5 Mailing Address
EDSA corner North Ave., Brangay
3 PRODUCT INFORMATION PROCEED Bagong Pag-asa, Quezon City, Metro
Manila
3.1 Product Category: Human Drug, Unbranded
6.1.1.0 Family
Latest photo of applicant Teano
.1.1 Valid Period Applied For (Years): 2 Name:
3.2.1 Generic Name 6.1.1.1 First
Khara Allyn
Losartan potassium 100mg Name(s): 6.1.6.0 E-mail Address:
film-coated tablet 6.1.1.2 Middle bsphcorp@gmail.com
Rebucas
Name: 6.1.6.1 Contact Detail 1
6.1.2 Designation: Head, Regulatory Affairs Mobile: #FMT
6.1.3 Tax ID Number: 12345678 6.1.6.2 Contact Detail 2
6.1.4.0 Type of Gov't ID: Professional Regulatory Commission Landline: 7974647
6.1.4.1 ID Number: 7546321 6.1.6.3 Contact Detail 3
3.2.2 EDL? Yes 3.2.3 Samples?: Yes 6.1.4.2 Date Expiry: 15-Aug-25 Fax: N/A
3.3.0 Drug Classification: RX 6.2 APPLICANT
3.3.1 Dosage Strength: 100mg Signature 6.2.5 Mailing Address
3.3.2 Dosage Form: Film-coated tablets EDSA corner North Ave., Brangay
3.3.3 Pharma Angiotensin II antagonists Bagong Pag-asa, Quezon City, Metro
Category: Manila
White opaque PVC/PVdC-Aluminium PROCEED 6.2.2.0 Family
3.4.0 blister packs: Latest photo of applicant
Name: Teano
Packaging: Pack size: 28, 30, 56, 90, 98 and 100 film-
coated tablets 6.2.2.1 First
Khara Allyn
3.4.1 Presentation/GPIN/GTIN: 3-76429-14211-7
HDPE bottle with polypropylene cap: Name(s): 6.2.6.0 E-mail Address:
Pack size: 30 and
3.4.2 Storage Condition: Not1000
abovefilm-coated
30 degreetablets
Celcius 6.2.2.2 Middle bsphcorp@gmail.com
Rebucas
3.4.3 Shelf-life: Not all pack sizes may be marketed.
3 years Name: 6.2.6.1 Contact Detail 1
3.4.4 Sugg. Retail Price 16.59php 6.2.2 Designation: Authorized Representative Mobile: #FMT
6.2.3 Tax ID Number: 12345678 6.2.6.2 Contact Detail 2
3.6 PCPR or CLIDP? No 6.2.4.0 Type of Gov't ID: Professional Regulatory Commission Landline: 7974647
6.2.4.1 ID Number: 7546321 6.2.6.3 Contact Detail 3
6.2.4.2 Date Expiry: 15-Aug-25 Fax: N/A

Off-white to beige, semi biconvex film-
CLOPIDOGREL (as BISULFATE) coated tablet with score on one side and
plain on the other side
Provide in this space a description of the
product in terms of rheology, thermal, and Use this space to explain how the lot code
geometry properties among others, as
used on the product label is correctly
applicable; Indicate if appropriate
microbiological cultures present in the interpreted
product
 Drug

This is the declaration form for pharmaceutical product registration by the Food and Drug Administration of the Philippines.

DECLARATION
We assume primary responsibility and/or stewardship over the product in case of liability, adverse events, or other public health & safety issues
arising from its use. We agree to have in good faith exerted due diligence in ensuring thatthird-party intellectual property rights are not infringed.
We further agree and bind ourselves that the label of the product shall at all times conform to the labeling regulations, and shall not be presented
including any advertisement of the product in a manner that is false, deceptive, misleading, or contrary to public morals/ public policy. Non-
observance of any of the undertakings in this declaration is deemed a misrepresentation which is a ground for disapproval of this application or, if
approved, the suspension or cancellation of the product registration.

Enclosed are the documents stated in the Checklist of Requirements for Registration and representative sample of our product.

We categorically declare that all data and information submitted in connection with this application as well as other submission in the
future are true and correct and reflect the total information available. We certify that we have examined the following statements and we
attest to their accuracy and truthfulness :
1.    The current Good Manufacturing Practice Guidelines is applied in full in the manufacture of this product.
2.  The formulation per dosage form is in agreement with the master formula and with the batch manufacturing record forms.
3.    The manufacturing procedure is exactly as specified in the master formula and batch manufacturing records.
4.    Product covered by this declaration will not undergo any change in formulation, dosage form, strength, therapeutic indication, manufacturer,
manufacturing process, labelling or commercial presentation without prior approval of the Food and Drug Administration.

5.    Each batch of all starting materials is tested or certified (in an accompanying certificate of analysis for that batch) against the full specifications in the
accompanying documentation and fully complied with those specifications cited in the claimed reference official monograph before it is released for
manufacturing purposes.
6.    All batches of active pharmaceutical ingredient/s (API) are obtained from the following sources:
Active Pharmaceutical Ingredient (API) Name and Address of API Manufacturer Name and Address of API Supplier
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;

7.    No batch of active pharmaceutical ingredient will be used unless a copy of the batch certificate established by the active ingredient manufacturer listed
above is available.
8.    Each batch of the finished product is tested and certified (in an accompanying certificate of analysis for that batch), against the full specifications in
the accompanying documentation and fully complied with the specifications cited in the claimed reference official monograph before it is released for
sale.
9.    The person releasing the product for sale is an authorized and/or qualified person.
10.  The procedures for control of the finished product have been validated for this formulation. The assay method has been validated for accuracy,
precision, specificity and linearity.
11.  The market authorization holder has a standard operating procedure for handling adverse reaction reports, and implementation of recall of its products.
12.  All the documentation referred to in this application is available for review during an audit or inspection.

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

Professional Regulatory
Commission:7546321 15-Aug-25
1) Khara Allyn Rebucas Teano ______________________________
Professional Regulatory
15-Aug-25
Commission:7546321
2) Khara Allyn Rebucas Teano ______________________________
Known to me and to me known to be the same persons who execute the application form and this declaration 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 : _____________________________
 Department of Health
Food and Drug Administration
APPLICATION FORM STATUS: APPLICATION FORM INFORMATION
4 SUPPORTING
1
GENERAL INFORMATION: PRO 1 1 0 0 0 0 0 SOURCES & CLIENTS: PRO 1 1 0 1
ESTABLISHMENT INFORMATION: PRO 1 0 0 1 1 Document Tracking Number 1 PR1
OC
PRODUCT INFORMATION: PRO 1 0 1 0 0 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: Drug 1.4 Primary Activity: Importer

2.1 Name of Establishment 1 1
1.2 Authorization: Product Registration
Mediserv Pharmaceuticals
1.3 Type: Initial 1 1 1
2.3 Tax Identification Number: 12345678
2.4 Office Address 2.5.1 RegioNCR
1 1
1.5 Current License Number: 873512345 EDSA corner North Ave, Barangay Bagong Pag-asa
1.5.1 Expiry Date: 15-Aug-2024 2.5 Warehouse Address 2.6.1 RegioIII
1 1
Your License will expire in 706 days. RV9J+5HQ
1
1 1 1
31-Dec-1899 1
2.7.0 E-mail Address: bsphcorp@gmail.com
2.7.1 Contact Detail 1 Landline: 79764647 1 1
0 2.7.2 Contact Detail 2 Mobile: 9094453321
0 0 2.7.3 Contact Detail 3 Fax: N/A
1 1
1

0 1 1 1
3 PRODUCT INFORMATION 0 PR
OC
1 3.1.1 Valid Period Applied For (Years): 2 EE1
Drug 1 1 HUHS 1 1D
Human Drug, UnbrandedFood 0
0 3.1 Product Ca Device 1 1
3.2.1 Generic Name 1 1
1 1 PR1
OC
1 EE1
0 1 1 1D
0 Losartan potassium 100mg film-c
1 Add Source 2 None 0
5.1.1 Type of Establishment: Wholesaler 1

3.2.2 EDL? Yes 3.2.3 Samples?: Yes

Type of Amendment:
Source: Add/ Delete FAL
Source: Change of Bu FAL
Change of Importer/ DFAL
Product Registration TRU
License to Operate FAL
ORDER OF PAYMENT
Amount Due:
Fee :
Legal Research Fee :
Surcharge :
OR Number :
Date Paid:
Computation Valid Until:
6 APPLICANT INFORMATION
1 3.3.1 Dosage Strength:
1 1 3.3.3 Pharma Category:
Other Amendments
0 License to Operate FAL
0 Reclassification FAL
0 0 Change of Distributor FAL
1 Finished Product FAL
0 Raw Material FAL
1 Free Sale, Certificate FAL
Pharmaceutical Product FAL
Export Certificate FAL
Additional ProductionFAL
3.3.0 Drug Classification: RX 5.1.2 Name of SouAurobindo Pharma - Milpharm Ltd. 1
White
100mg opaque PVC/PVdC-Aluminium blister packs:
3.3.2 Dosage Form: Pack size: 28,tablets
Film-coated 30, 56, 90, 98 and 100 film-coated tablets
HDPE bottle with polypropylene cap:
Angiotensin
Pack size: 30IIand
antagonists 5.1.3
1000 film-coated Office AddreOdyssey Business Park, Ares Block, West End R
tablets 1
0 3.4.0 Packaging: Not all pack sizes may be marketed.5.1.4 Local FDA License Number: PL 16363/0422 1
0 3.4.1 Presentation/GPIN/GTIN: 3-76429-14211-7 5.1.5 Tax Identification Number: 4200021 1
0 3.4.2 Storage Condition: Not above 30 degree Celcius 5.1.6 Contact Detail 1 Landline: (0)208 845 8811 0 1
0 0 3.4.3 Shelf-life: 3 years 5.1.7 Contact Detail 2 Fax: (0)208 845 87 1 01 1
0 3.4.4 Sugg. Retail Price 16.59php
None 0 None 0
0
0 1 1 1
0 3.6 PCPR or CLIDP? No
0 0
0 0 1 1 1
1
4040
4000 1 1
40 1 1
0 1 1
0 1 0 1
This is the application form. Without the appropriate petition or 01 1 01 1
0 declaration form, this application may be rejected.
None 0 None 0
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

Latest photo of applicant
6.1.2 Designation:
6.1.3 Tax ID Number:
6.1.4.0 Type of Gov't ID:
6.1.4.1 ID Number:
6.1.4.2 Date Expiry:
6.2 APPLICANT
Latest photo of applicant
6.2.2 Designation:
6.2.3 Tax ID Number:
6.2.4.0 Type of Gov't ID:
6.2.4.1 ID Number:
6.2.4.2 Date Expiry:
6.1.5 Mailing Address
Signature
6.1.1.0 Family Na Teano
EDSA corner North Ave., Brangay Bagong Pa
6.1.1.1 First Name(Khara Allyn 6.1.6.0 E-mail Address:
bsphcorp@gmail.com
6.1.1.2 Middle Na Rebucas 6.1.6.1 Contact Detail 1
Head, Regulatory Affairs Mobile:
12345678 6.1.6.2 Contact Detail 2
Professional Regulatory Commission Landline:
7546321 6.1.6.3 Contact Detail 3
45884 Fax: N/A
6.2.5 Mailing Address
Signature
6.2.2.0 Family Na Teano
EDSA corner North Ave., Brangay Bagong Pa
6.2.2.1 First Name(Khara Allyn 6.2.6.0 E-mail Address:
bsphcorp@gmail.com
6.2.2.2 Middle Na Rebucas 6.2.6.1 Contact Detail 1
Authorized Representative Mobile:
12345678 6.2.6.2 Contact Detail 2
Professional Regulatory Commission Landline:
7546321 6.2.6.3 Contact Detail 3
45884 Fax: N/A
1 1
1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0
1 1
9094453321 1 1
7974647
1 1
1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0
1 1
1 1
9094453321 1 1
1 1
7974647 1 1
0 1 0 1
01 1 01 1

Page 7 of 15 611401908.xlsx 09/09/2022 00:27:19

 Department of Health
Food and Drug Administration
APPLICATION FORM

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 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 9 of 15 611401908.xlsx 09/09/2022 00:27:19

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 10 of 15 611401908.xlsx 09/09/2022 00:27:19

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