You are on page 1of 24

APPLICATION NO:-------

PREPARED BY: DR ARIF HUSSAIN


COMPANY NAME: LARAIB HERBAL PHARMA
ADDRESS: PLOT NO. 25, 26 MAIN DERA

MUHAMMADI ROAD NEAR BAHAWALPUR BY


PASS MULTAN

1|Page

Letter No.

Date:

Director Health & OTC


Drug Regulatory Authority of Pakistan,
TF- Complex, Islamabad.

Application for Enlistment of Firm/Company

Subject:
Dear Sir,

PLEASE SEE ATTACHED THE APPLICATION ON FORM 1 FOR THE ENLISTMENT OF M/SLARAIB HERBAL PHARMA, LOCATED AT PLOT NO. 25, 26 MAIN DERA MUHAMMADI
ROAD NEAR BAHAWALPUR BY PASS MULTAN
as a manufacturer of Unani/Ayurvedic Products without prejudice to CP 4387 of 2014 pending in
the High Court of Sindh Karachi. M/s LARAIB HERBAL PHARMA is the active member of
Pakistan Tibbi Pharmaceutical Manufacturers Association, the Official trade Organization under
Section 3(2)(d) of the Trade Organizations Act 2013, to represent the Tibbi Pharmaceutical
Sector on all Pakistan basis.
You are requested to acknowledge the receipt of documents.
Thanking You,
Muhammad Mursaleen
Managing Director

Signature

Date

Company Stamp

2|Page

Screening of Documents and Inspection Criteria Checklist for


Unani/Ayurvedic Manufacturers for Enlistment Certificate

S.
No.

PARAMETER

Application on prescribed form 1 by Manufacturer

Copy of the constitution of firm and National Tax Number

Site Master File(Fill information as Approved Template)

Attach List of sections

Attach certificate of Pharmacist/BEMS Qualified production & QC incharge.

Name and address of the Director, Partners or proprietor

Proof of Payment of the fee (Original Challan).

Ownership, Rent or lease detail of the premises in case of grant of


enlistment certificate as manufacturer.

list of currently used machinery and laboratory equipment

10

Weighing scale calibration certificate will be attached.

11

An undertaking by the applicant for ownership of the equipment listed


against point 9.)

12

Space allocated in sq feet against each section as listed in point 4

13

List of firms/companies applied for enlistment under the contract


manufacturing or testing. (Applicable for contractmanufacturing/testing)

14

Letter from manufacturer being ready for inspection

15

Signature and undertaking by the applicant.

YES

NO.

3|Page

Annex. No.1
SCHEDULE A
[See rule 3(3)]
Form 1
[See of rule 3(3)]
APPLICATION FOR ENLISTMENT OF MANUFACTURER OR CONTRACT GIVER
(Attach readable soft copy with application)
I/WE LARAIB UNANI PHARMA,Plot No. 25, 26 Main Dera Muhammadi Road
Near Bahawalpur by pass MULTAN, Muhammad Mursaleen Holder (s) of
CNIC No. 36302-3299569-9 Having NTN 4303368-7 and Ejaz Hussain
Holder (s) of CNIC No.36302-3188372-7 Having NTN 4303531-7 Owner of
M/s Laraib Herbal Pharma hereby apply for enlistment of my Proprietorship
firm / company established, located at the premises as under Plot No. 25, 26
Main Dera Muhammadi Road Near Bahawalpur by pass MULTAN.
(A) That I am manufacturing following classes of therapeutic goods
1. Alternative Medicines. (Attach detail information as Annex-A)
a. Herbal Medicinal product or Phytopharmaceuticals(standardized extracts) or
phytomedicine
b. Indigenous or Unani Medicines or traditional Medicines.
c. Homeopathic Medicines.(mother tincture, sarcode, Nosode , Allersode, Isode or any other
homeopathic preparation or dosage form )
d. Bio-chemic Medicines.
e. Herbal oils / Balms
f. Any other alternate/ complementary medicines.
2. Health and OTC Products. (Attach the information as Annex-B)
a. Food supplements (Neutraceuticals or dietary or health supplements).
b. Nutritional supplements, pro-biotics and pre-biotics
c. Baby Milks and Foods (infant or baby formulae, follow up formulae, formulae for special
medical purposes or complementary foods intended for infants and young children).
d. Disinfectants.
e. Medicated cosmetics, and shampoos containing natural ingredients.
f. Medicated Soaps containing natural ingredients
g. Tooth pastes/mouthwashes/throat lozenges/gargles containing natural ingredients.
h. Medicated cosmetics/Derma-care products/Balms/ patches/ medicated oils natural
ingredients
4|Page

i. Any other.
3. That my manufacturing unit has following facilities:
(Attach the site master file as Annex-C)
4. Total size of the plot/ building is ..sq/feet.

5|Page

5. No. of sections are as under: - (Attach list of equipment and instruments available with
copy of invoice for each section)
a. Tablets.
b. Capsules.
c. Dry Syrup.
d. Dry powder (s).
e. Liquid Solution, Syrup, emulsion, paste, suspensions, drinking ampoules and Drops.
f. Ointment and Creams.
g. Sachet/herbal teas/joshanda.
h. Eye/ Ear/ Nasal Drops.
i. Packaging and Labeling.
j. Quality Control Lab (pharmacognosy, chemistry and microbiology laboratories).
k. Warehouses.
l. Sterilization facility.
m. Any other section.
6. Our facility has following staff: (Attach the information as Annex-D)
a. Qualified staff name, qualification, experience and training. State responsibility and attach
their CVs.
b. Supportive and non-technical staff.
7. Fee deposit bank receipt.
8. I undertake and certify that the contents stated above are correct and true to the best of
my knowledge (please attach undertaking on the notarized stamp paper.

Muhammad Mursaleen
Managing Director

Seal of the Firm/ Company.


Dated..................

6|Page

Annex. No.2
Attach Copy of the constitution of firm and National Tax Number certificate.

Annex. No.3
7|Page

Site Master File


Site Master file template is given below for the Unani Manufactures to submit information
of the manufacturing facility for enlistment as manufactures.

Contents
Sr. #

Sr. No

Title

Page No

1.

Brief Introduction of the Manufacturer

2.

Name & Address and Contact Persons.

3.

Qualified technical staff

4.

Description of the Site

5.

Manufacturing and quality control facilities including list of


Sections and other areas of the facility.

6.

Organizational Chart along with job responsibilities of technical


persons for various functions.

7.

Miscellaneous information regarding import export, certifications


and other relevant particulars.

Activity

Name and
Designation

Department

Signature & date

8|Page

Prepared by

Dr Arif
Hussain

Production Manager

Reviewed by

Dr.Haider Ali
Tabasam

Q.C Incharge

Approved by

Mr.Muhammad
Mursaleen

Managing Director

1. BRIEF INTRODUCTION OF THE ORGANIZATION:

Laraib Herbal Pharma is a traditional Unani products manufacturing firm with its
headquarters in Multan and marketing office in Multan.
Laraib Herbal Pharma was founded in 2005; it is engaged in manufacturing and
marketing of Traditional Tibb e Unani Products (Sharbat, majoon,Safof,Rogan etc).
Laraib Herbal Pharma strives to provide high quality Tibb e Unani products that
improve the health of the customers. A team of personnel of various disciplines are
working towards to meet the customers requirements and the objective of continuous
improvement in quality.
This Site master file is related to Laraib Herbal Pharma, dedicated to manufacturing of
Traditional Unani Formula Preparation, located at Plot No. 25, 26 Main Dera
Muhammadi Road Near Bahawalpur by pass MULTAN

2. NAME AND ADDRESS


Office Address

Plot No. 25, 26 Main Dera Muhammadi Road Near


Bahawalpur by pass MULTAN
9|Page

Site Address

3.

Plot No. 25, 26 Main Dera Muhammadi Road Near


Bahawalpur by pass MULTAN

Qualified technical Staff.

Name of Person

Office Phone No.

Mobile No.

Dr Arif Hussain

+92-300-6373746

03007331202

Dr. Haider Ali


Tabasam

+92-300-6373746

03457709350

4. DESCRIPTION OF THE SITE

Total Land Area

3200sq/feet

Total Build up Area

3000sq/feet

Annex. No.4
5. Manufacturing and quality control facilities including list Sections and other areas of the
facility.

10 | P a g e

Sr.
No

Area
Sqft.

Name of Facility and Sections

Araq

188sq/feet

Safoof (Powder)

288sq/feet

Roghan (Oils, Crushing and boiling)

188sq/feet

Sharbat & Joshanda

625sq/feet

Bhatti, Furnace, Boilers,

235sq/feet

Quality Control Area

300sq/feet

Raw Material Store

325sq/feet

Packaging Material Store

288sq/feet

Finished Goods Store

288sq/feet

6. Functions Organizational Chart along with job responsibilities of technical persons for
various.

Sr.
No
1

Technical Person
Name
Mr.Dr Arif Hussain
(Production Manager)

Dr Haider Ali Tabasam


(Production Manager)

Job Responsibility
To do planning, organizing, staffing, leading, and
controlling activities for manufacturing facilities.
Responsible for Quality Assurance & Control
activities.

Annex. No.5
Attach certificate of Pharmacist/BEMS Qualified production & QC in-charge.

11 | P a g e

Annex. No.6

Name and address of the Director, Partners or proprietor


12 | P a g e

Sr. No.

Name

Address

Mr.Muhammad Mursaleen

Mr.Ejaz Hussain

Old Shujabad Road Malik Allah Bukhsh


Street Whida abad Multan.
Suraj miani Raod Street No. 3 Muhallah
Noor Islam Colony Multan.

Annex. No.7

Proof of Payment of the fee (Original Challan).


13 | P a g e

Attach bank receipt original copy (DRAP)

Annex. No.8

14 | P a g e

Ownership, Rent or lease detail of the premises in case of grant of enlistment


certificate as manufacturer.
Attach Rent agreement copy/ownership evidence copy

Annex. No.9
Write the equipment detail in relevant box

15 | P a g e

Sr. No
1

Name of Facility and Sections

List of Equipment

Araq
Arq Kasheed Plant (1)
Arq Storage Tanks (2)
Arq Filling Machine (1)
Trolleys (1)
Digital Balances (2)
Shirink Machine Gun (1)
Sealing Machine (1)

Safoof (Powder)

Grinder

(1)

Trolleys (1)
S.S Scopes of different sizes
S.S Trayes of different sizes
Digital Balances (2)
Sealing Machine (1)
Shirink Machine Gun (1)
3

Roghan (Oils, Crushing and


boiling)

Stainless Steel mixing Tank of different


sizes (1)
Trolleys (1)
Digital Balances (2)
Sealing Machine (1)

Sharbat & Joshanda

Silver son Apparatus (1)


Water reverse osmosis plant (2400 lit.
capacity) (1)
Stainless Steel mixing Tank of different
sizes (4)
Sieving Apparatus of different mesh size
(4)
Liquid Transfer Pump (2)

16 | P a g e

Syrup Transfer & Filtration System


Liquid Transfer Lines of different length
(6)
Storage tank of different sizes (2)
Semi-automatic bottle filling machine (1)
S.S Scopes of different sizes
Trolleys (1)
S.S Scopes of different sizes
Sealing Machine (1)
Shirink Machine Gun (1)

Bhatti, Furnace, Boiler,

Quality Control Area

Bhati (3)
Digital viscometer (1)
Refractrometer (1)
Melting Point Apparatus (1)
Polarimeter (1)
Centrifuge Machine (1)
Precision Balance (1)
Top Loading Balance (1)
Magnetic Stirrer with Heating System (1)
Thermostatic Water Bath (1)
pH Meter (Micro Processor) (1)
Moisture Analyser (1)
Conductivity / TDS Meter (1)
Refrigerator (1)
Glass Apparatus (1)
Laminar Flow Hood (1)
Autoclave (1)

17 | P a g e

Incubator (1)
Chemicals , Glassware etc
S.S Scopes of different sizes
7

Raw Material Store

Racks
Pallets
Weighing Balance
S.S Scopes of different sizes

Packaging Material Store

Racks
Pallets

Finished Goods Store

Racks
Pallets

Annex. No.10

18 | P a g e

Attach weighing scale calibration certificate copy

Annex. No.11

19 | P a g e

TO WHOM IT MAY CONCERN

I undertake and certify that the list of equipment and instruments stated above are present at
our site and can be verified during inspection for enlistment.

Muhammad Mursaleen
Managing Director

Signature: -------------------Dated.................................
.

Annex. No.12
Space allocated in sq feet against each section as listed in point 4
20 | P a g e

Sr.
No

Name of Facility and Sections

Area
Sqft.

Araq

188sq/feet

Safoof (Powder)

288sq/feet

Roghan (Oils, Crushing and boiling)

188sq/feet

Sharbat & Joshanda

625sq/feet

Bhatti, Furnace, Boilers,

235sq/feet

Quality Control Area

300sq/feet

Raw Material Store

325sq/feet

Packaging Material Store

288sq/feet

Finished Goods Store

288sq/feet

Annex. No.13

21 | P a g e

List of firms/companies applied for enlistment under the contract


manufacturing or testing. (Applicable for contract manufacturing/testing)

Annex. No.14

22 | P a g e

Director Health & OTC


Drug Regulatory Authority of Pakistan,
TF- Complex, Islamabad.

Subject: Letter from Manufacturer being ready for inspection

Dear Sir,
It is hereby requested that M/s Laraib Herbal Pharma is ready for the
inspection. Kindly order for the inspection for the Enlistment as a
Manufacturer of Tibb e- Unani/ herbal Products

Looking Forward,

Muhammad Mursaleen
Managing Director
Date
Stamp

Annex. No.15
23 | P a g e

Signature and undertaking by the applicant.

I undertake and certify that the contents stated above are correct and true to the best of my
knowledge.

Muhammad Mursaleen
Managing Director

Dated..................................

24 | P a g e

You might also like