SIPRA Labs Limited Date: 11/04/14

SIPRA Labs Limited Date: 11/04/14 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,

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,

Dr. V. Satyanarayana Managing Directior Sipra Labs Ltd “SIPRA FIRST” FORM

SIPRA LABS LIMITED Sanathnagar, Hyderabad-500018 Form No:

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) (4)

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: PHOTO 5) Number of People Working in Your Team:

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 2) Stability Studies 3) Method Development 4) Packaging Material 5) BA/BE Studies 6)Preclinical Studies 7) Invitro Studies 8) Facility Monitoring 9) Microbiology 10) Biotechnology 11) Environmental Studies

2) Regulatory Status of SIPRA is given below

1) US FDA 2) TGA Australia 3) Health Canada 4) MCC South Africa 5) NABL 17025 6) Medical ISO 15189: 2007 7) DCGI 8) DST approved R & D 9) CPCSEA registered animals facility

3) New Services added in the last one year in SIPRA

1) HPLC – ELSD & ECD 2) Air jet Sieve 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

1) Leachables and Extractables 2) ICP-MS studies 3) Invitro Assays

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 S. Equipment Name Model Make No 1 LC-MS/MS (5 Nos) API- 4000, 3000, 2000 Applied Biosystems 2 GC-MS/MS with Head Space (3 Quattro micro, Clarus Waters, Perkin ,Agilent Nos) 500, 7000 Triple Quadrupole 3 ICP-MS (2 Nos) 7500, 7700 Agilent Technologies 4 Scanning Electron Microscope SU1510 Hitachi 5 X-RAY Diffractometer X’Celerator X’Pert Pro PANalytical 6 T.G.A. & DSC (2 Nos) Pyris 6, DSC 8000 Perkin Elmer 7 CHNSO Elemental Analyser VARIO EL III Elementar 8 AAS Analyst 700, 800 Perkin Elmer 9 Surface Area & Pore Size Analyzer Tristar 3000 Micromeritics 10 GC Headspace (10 Nos) 6890, 7890 , Clarus Agilent 680 11 Particle size Analyser Mastersizer-S, 2000 Malvern AS 200 Jet, Sympatec H254Z Retsch 12 H.P.L.Cs with UV, RID, 1100, 1200 Series Waters, Agilent Flourscence, ECD, ELSD, PDA and Alliance MS Dionex UltiMate 3000 Thermo LC 2010 Shimadzu 13 FTIR with HATR (2 Nos) Spectrum One Perkin Elmer 14 UV/VIS Spectrometer (3 Nos) Lambda-35 Perkin Elmer 15 Walk-in Stability Chambers (10 Nos) 11000 lt, 8500 lt, 8000 Thermolab, Carrier, and Photo Stability Chambers kt and Mack 16 Dissolution Appartus Auto (6 Nos) VK8000 Bio-Dis (USP Agilent USP I, USP II, USP III, USP V, USP III) Lab India VI Disotest

17 Osmometer 3250 Advanced Instruments Inc 18 Ion Chromatograph (4 Nos) 861 Metrohm 19 Capillary Electrophoresis 7100 Agilent 20 Polarigraph 797 VA Computrace Metrohm 21 PCR-Realtime QST Step 1 Applied Biosystems 22 Fully Automated Histopathology TP 1020, XL, RM Leica 2125 RT, EG1150H, EG 1150C 23 Microwave Digester Multiwave 3000 Perkin Elmer