SIPRA Labs Limited
7-2-1813/5/A, Adjacent to post office
Sanath Nagar Industrial Estate
Hyderabad
SUB: Two Decades of Regulatory Services to Pharmaceutical Industry
Dear Sir/Madam,
Date: 11/04/14
We are glad to inform you that Sipra is completing Two Decades of fruitful association with the pharmaceutical industry by providing the Regulatory Research services. Sipra always believed in the policy of “Compliance First” and “Customer is our Boss” and strived all these years to fulfill the wide ranging aspirations of its esteemed clientele.
We are deeply indebted for the continued support provided by you, your organisation and industry as a whole. All these years, your organisation has appreciated our technical strengths and allowed us to continue our services.
On this auspicious occasion of completing Two Decades in customer service, we are launching a program called “SIPRA FIRST”, means SIPRA has to receive the first call from their clients for their future requirements.
In order to achieve these and to improve our services further, we are creating a data base of our esteemed clients, and their current and future outsourcing needs. We would like to have an interaction with you to get your honest and worthy feedback on our services as part of Two Decades in customer service. Also we will be in regular touch with you through Client Relation Management for every enquiry and query you have on our services.
We thank you very much for your kind support and the honest feedback.
Thanking you,
From
Dr. V. Satyanarayana
Managing Directior
Sipra Labs Ltd

“SIPRA FIRST” FORM
SIPRA LABS LIMITED
Sanathnagar, Hyderabad-500018
SECTION I: About Your Organisation
1) Name of Organisation:
2) Chairman:
3) Managing Director:
4) Head Office Address:
Contact No:
5) Manufacturing / R & D Plants (Please provide the name of the locations):
S. No (1) (2) (3)
R & D
Form No:
(4)
API
Formulations
Regulatory Status
(Ex: USFDA, TGA,
& etc)
6) Kindly specify your future expansion belongs to new plants?
7) Kindly specify the presentable regulatory planning’s of your Organisation?
8) What are your expectations from an Outsourcing Partner?
9) Kindly suggest some outsourcing services you are feeling difficult to manage?

SECTION II: Details of the Person Filling the Form and his Unit
1) Name of the Person:
2) Designation:
3) Unit & Division:
4) Job Description:
5) Number of People Working in Your Team:
PHOTO
6) Regulatory approvals of your Facility: Phone:
Email:
7) Please specify the pharmacopieal studies being outsourced by your organisation:
8) Does your facility/organisation require any additional studies for outsourcing (for present & upcoming products)?
9) Facility monitoring services (particle count, bio-load, flow and pressures) are launched by SIPRA recently. Does your GMP facility require it?
10) Do you have any requirement of CRO services?
11) Please name the services your organisation is outsourcing to others (other than to SIPRA)?
12) Can you give details of your associates who require our services?
13) How long you are associated with SIPRA?
14) Kindly specify the reasons for selecting SIPRA:

SECTION III: About SIPRA
1) Present Service Group of SIPRA
1) Analytical
4) Packaging Material
2) Stability Studies
5) BA/BE Studies
3) Method Development
6)Preclinical Studies
9) Microbiology 7) Invitro Studies 8) Facility Monitoring
10) Biotechnology 11) Environmental Studies
2) Regulatory Status of SIPRA is given below
1) US FDA 2) TGA Australia
4) MCC South Africa 5) NABL 17025
3) Health Canada
6) Medical ISO 15189: 2007
7) DCGI 8) DST approved R & D
3) New Services added in the last one year in SIPRA
1) HPLC – ELSD & ECD 2) Air jet Sieve
9) CPCSEA registered animals facility
3) Scanning Electron Microscope
4) GC-MS/MS 5) IC- Amperometry 6) GC – Gas Analysis
4) Sipra is equipped with the new requirements of USP. Does your organisation interested in any of the these
3) Invitro Assays 1) Leachables and Extractables 2) ICP-MS studies
5) Sipra is planning to purchase following instruments this year
1) NMR 500 MHz 2) USP-4 Dissolution 3) BIA-CORE
You may Tick the above services of your interest or services used by your facility in SIPRA
SECTION IV: Requirement of Industry in General (Please Answer Based on Section III)
1) Please suggest any additional service group to be introduced in Sipra for Industry in general:
2) Kindly specify any other regulatory requirement, which help the industry (other than specified above):
3) How SIPRA can participate in your future activities as an outsourcing partner?
4) Can you suggest the improvements required in SIPRA’s Service?
5) Sipra must do this to qualify for your requirements:

Section V: Major List of Equipments in SIPRA
3
4
5
6
S.
No
1
2
7
8
Equipment Name Model Make
LC-MS/MS (5 Nos)
GC-MS/MS with Head Space (3
Nos)
API- 4000, 3000, 2000 Applied Biosystems
Quattro micro, Clarus Waters, Perkin ,Agilent
500, 7000 Triple
Quadrupole
ICP-MS (2 Nos) 7500, 7700
Scanning Electron Microscope SU1510
X-RAY Diffractometer X’Celerator
X’Pert Pro
T.G.A. & DSC (2 Nos) Pyris 6, DSC 8000
Agilent Technologies
Hitachi
PANalytical
Perkin Elmer
CHNSO Elemental Analyser
AAS
VARIO EL III
Analyst 700, 800
Elementar
Perkin Elmer
Micromeritics
Agilent
9 Surface Area & Pore Size Analyzer Tristar 3000
10 GC Headspace (10 Nos) 6890, 7890 , Clarus
11 Particle size Analyser
680
Mastersizer-S, 2000
12 H.P.L.Cs with UV, RID,
Flourscence, ECD, ELSD, PDA and
MS
AS 200 Jet,
H254Z
1100, 1200 Series
Alliance
Dionex UltiMate 3000
LC 2010
Malvern
Sympatec
Retsch
Waters, Agilent
Thermo
Shimadzu
13 FTIR with HATR (2 Nos)
14 UV/VIS Spectrometer (3 Nos)
15 Walk-in Stability Chambers (10 Nos) and Photo Stability Chambers
16 Dissolution Appartus Auto (6 Nos)
USP I, USP II, USP III, USP V, USP
VI
17
18
22
23
Osmometer
Ion Chromatograph (4 Nos)
19 Capillary Electrophoresis
20 Polarigraph
21 PCR-Realtime
Fully Automated Histopathology
Microwave Digester
Spectrum One
Lambda-35
11000 lt, 8500 lt, 8000 kt
VK8000 Bio-Dis (USP
III)
Disotest
3250 Advanced Instruments
Inc
Metrohm 861
7100 Agilent
797 VA Computrace Metrohm
QST Step 1
TP 1020, XL, RM
2125 RT, EG1150H,
EG 1150C
Multiwave 3000
Perkin Elmer
Perkin Elmer
Thermolab, Carrier, and Mack
Agilent
Lab India
Applied Biosystems
Leica
Perkin Elmer