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5/6, Ramkrishnanagar, Off E.E.Highway, opp. Hotel Sharanam, Thane (W). 40060, Maharashtra State, India Telefax: +91-22-25811244, E mail: [email protected]

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Overview

Technolutions Projects Pvt Ltd (TPPL) was established as a partnership venture in 2001 for providing

consultancy services in various areas of Pharmaceutical and Biotechnology Industry.

TPPL is managed by five technically qualified experienced professionals from the Industry with a

minimum professional experience of over 25 years each.

TPPL offers a wide range of services for a variety of projects including oncology and biotech facilities

world over. These include the following major categories given below.

Services Offered:

I. Technical due diligence of existing facilities.

II. Feasibility studies for new facilities.

III. Concept design and gross cost estimates for new facilities.

IV. Detailed Design and Engineering of various disciplines for facilities.

V. Site supervisions services.

VI. Training and Validation Services.

Currently TPPL is executing a number of projects in India, Turkey, Pakistan and Bangla Desh.

These include Oncology Formulations, Biotech API and Formulations as well as Hormones and

general products formulations. The details of all the projects are provided later on in this profile.

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Milestones

• 2001: Technolutions was established as a partnership venture. The founder partners were

Mr. K.Y. Chandgude and Mr. P.K. Kulkarni.

• 2002-2006: Mr P K Kulkarni also provided consultancy to Mott McDonald for about 25

projects.

• 2001 -2007: Technolutions have completed a wide range of products from Technical Due

Diligence to Multi dosage forms projects including Validation services.

• 2004: Bagged a major project: Promed Exports at Nalagarh, HP. Scope included site

selection to Validation.

• 2005: Mr Kishor Datar from Sandoz India joins Technolutions

• 2007: Prestigious projects: Sanovel, Turkey; Incepta, Bangladesh & Getz Pharma, Pakistan

• 2007: December: Mr Milind Jog from Mott McDonald Consulting (formerly M/s Dalal

Consultants Joins Technolutions

• January 2008 Ajit Kanetkar from PamGlatt / ACG joins Technolutions

• 2007-2008: Gross turnover for current year over Rs 22 mn

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Current Projects

Client Category Scope of Services Status

Promed Exports,

New Delhi.

Ph-I 2004

Ph-II 2007

BFS(Blow-fill-seal)

sterile products facility

for EU, US & Russia

o Site selection

o Concept development

o Basic engg.

o Detailed engg.

o Commissioning &

Validation

Design of Phase II

started in December

2007

Pharmaceutical

Coatings,

Goa, India

Oral solid dosage forms o Concept development

o Basic engg.

o Detailed engg.

o Validation support

Detailed engg.

completed.

Civil work started in

November 2007

Rubicon

Research,

Mumbai, India

CRO unit: formulation

development and mfg

unit


o Basic engg.

o Detailed engg.


Detailed engg.

completed.

Civil work

completion: April

2008

Star Drugs &

Research Labs,

Bangalore, India

Oncology Injectables o Concept development

o Basic engg.

o Detailed engg.

Detailed engg.

completed. Civil

work completion by

June 2008

Atra Pharma,

Aurangabad,

India

Oral solid dosage forms o Concept development

o Basic engg.

o Detailed engg.

Detailed engg. and

civil execution in

progress

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Current Projects (Contd.)

Sanovel,

Istanbul, Turkey

o Oncology Injectables

o Oncology OSD

o Mammalian cell

culture & bacterial

fermentation, Biotech

API plant

o Formulation mfg of

Biotech formulations

o Formulation

development for all

other non-cytotoxic

dosage forms


o Gross costing

o Basic engg.

o Partial Detailed engg.

Process equipment

specs under

development.

Formulations R&D

concept

development

completed

Getz Pharma

Research,

Mumbai, India

CRO unit with

formulations R&D,

Analytical

Development Lab,

Liquid Injectables for

general & Cytotoxic

products, Pilot plant

for formulations.


o Basic engg.

o Detailed engg.

Concept

Development &

Basic engg.

completed. Civil

work expected for

completion by

August 2008

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Current Projects (Contd.)

Client / year Category Scope of Services Status

Getz Pharma,

Karachi, Pakistan

o Oral solid dosage

o General liquid &

lyophilised injections

o Cephalosporins OSD

o Cephalosporins

Powder Injections

o Soft gel capsules

o Proposed BFS


o Basic engg.

o Detailed engg.

o Procurement assistance

o Commissioning &

Validation

Basis of design for

general products &

cephalosporins

completed.

Incepta Pharma,

Dhaka,

Bangladesh

Oral contraceptives

formulations facility.

Includes tablets and

injectables including

depot formulations

o Development

o Basic engg.

o Detailed engg.

Detailed engg.

completed.

Dr Palep’s

Medical Research

Foundation,

Mumbai, India

Ayurvedic formulations

mfg facility near

Mumbai, India


o Basic engg.

o Detailed engg.

o Procurement assistance

o Site supervision


Basis of design

under discussion.

Hebei Changshan

Biochemical

Pharmaceutical

Co Ltd, China

Review of existing

facility

Technical due diligence Review and report

completed.

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Completed Projects (Technolutions)

Client Category Scope of Services

Universal Medicap, Baroda,

India

Yr 2000

RFS closures for EU & US

markets.

300,000/day

Granted Type III DMF

Concept to commissioning

including validation.

MicroLabs, Goa, India

Yr: 2002

Oral Solid Dosage

2 bn units p.a.

Plant Approved by MHRA


o Basic Engineering

design

Sandoz Pvt Ltd (Formerly

Novartis Pvt Ltd)

Thane India

Yr: 2003

Cephalosporins: Powders for

Oral suspension

o Feasibility Report

Aga Khan Foundation for

Economic Development,

France

Yr: 2004

For BFS injectables facility in

Afghanistan

o Concept Development

o Basic engineering

o Validation

Lucid Pharma

Pune, India

Yr: 2004

Oral solid dosage

Cap: 2 bn units p.a.


o Basic engineering

o Validation

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Completed Projects (Technolutions) (Contd.)


Blue Cross Labs,

Nashik, India

Yr: 2005

Oral solid dosage o Compliance Audits of

existing facilities at

Nashik & Goa

o Concept

Development, Basic

engg. & Detailed

engg. for a new OSD

facility

Apotex Research,

India, For Canada

Yr: 2005

Oncological injectables

facility In Canada


o Basic engineering

Reliance Life-Sciences,

Navi Mumbai, India

Yr : 2006

Biotech derived injectables o Concept development

o Basic engineering

o Detailed engineering

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Oros Pharma, Jammu, India

Yr: 2006

Oral solid dosage o Concept development

o Basic engineering


Emcure Pharma,

Pune, India

Yr: 2006

Oncological injectables o Concept development

o Basic engineering


Natco Pharma,

Hyderabad, India

Yr: 2007

Oncological Injectables o Concept development

o Basic engineering

Aurolab,

Madurai, India

Yr : 2007

o Intra-occular lenses

o Surgical blades

o Sutures

o Opthalmic preparations

o Injectables

o Total: From Concept

to commissioning and

validation

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Incepta Pharma,

Dhaka, Bangladesh

Yr: 2007

Oral Solid dosage o Concept development

o Basic engineering

Yashraj Biotechnology Ltd,

Mumbai, India

Biotech derived diagnostic

agents


o Basic engineering

o Detailed engineering,

o Site supervision

o Training for

Validation

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Projects done for Mott MacDonald

Client Category Project Leader

Sandoz India, New

Kalwa plant,

Thane, India

Oral solid dosage

Cap: 1 bn units

Plant Approved by EU, US FDA, MCC & TGA

P K Kulkarni

Wyeth Ltd,

Goa, India

Plant expansion for oral contraceptives, steroids

and general steroids

P K Kulkarni

UCB Ltd,

Vapi, India

Oral solid dosage forms and oral liquids.

Greenfield project

P K Kulkarni

Wockhardt Ltd,

Aurangabad, India

Biotech Injectables and Central Technical

Establishment for Biotech plants.

Plant approved by MHRA

P K Kulkarni

CCM/UPHA

Pharma,

Malaysia

Multi Dosage forms facility: Concept and Basic

Engg.

P K Kulkarni

Dr Reddy’s

Hyderabad, India

Oncology API plant P K Kulkarni

Ranbaxy Labs Ltd,

PaontaSahib, India

Soft gel Capsule plant expansion P K Kulkarni

Ranbaxy,

Paonta Sahib,

India

Cephalosporins & Penicillins: Oral solid dosage

plant

P K Kulkarni

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Projects done for Mott MacDonald (Contd.)


Wockhardt Ltd,

Aurangabad, India

Oral solid dosage forms P K Kulkarni

Dr Reddy’s,

Hyderabad, India

Oral Contraceptive tablets, Pilot plant facility P K Kulkarni

Novartis Ltd,

Basel, Switzerland

Concept Study for formulation development

and Clinical trial facility at Pune, India

P K Kulkarni

Shreya Biotech

Ltd, (now known

as Scigen India

Ltd), Pune, India

Mammalian Cell Culture and bacterial

fermentation API facility

P K Kulkarni

KAPL,

Bangalore, India

Small volume parenterals P K Kulkarni

Rubamin Pharma,

Baroda, India

High potency API facility P K Kulkarni

Aristo Pharma,

Mumbai, India

Oral solid dosage forms, Oral Liquids and Soft

gel capsule plant at Baddi, HP, India

P K Kulkarni

Nicholas Piramal,

Baddi, HP, India

Oral solid dosage forms, Oral Liquids and Soft

gel capsules

P K Kulkarni,

K D Datar &

M V Jog

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Zenotech Labs,

Hyderabad, India

Biotech API and formulations for mammalian

cell culture and bacterial fermentation products

P K Kulkarni

Hikal Chemicals

Ltd,

Mumbai, India

Kilo lab facility at Bangalore, India P K Kulkarni

Sandoz India,

Navi Mumbai,

India

Carbapenem APIs and sterile powder filling

facility

P K Kulkarni &

K D Datar

Wockhardt Ltd,

Shendre,

Aurangabad, India

Injectables facility K D Datar &

M V Jog

Erica Pharma,

Goa, India

Oral solid dosage forms and External

Preparations

K D Datar

Sandoz India Ltd,

Thane, India

Formulations Development Centre

Approved by Sandoz Global and US FDA

K D Datar

Sandoz India Ltd,

Thane, India

Cephalosporins

Approved by Sandoz Global & US FDA

K D Datar

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Sandoz India Ltd,

Kalwe, India

Oral solid dosage forms.

Approved by Sandoz Global, US FDA, EU,

TGA & MCC

K D Datar &

M V Jog

Sandoz India,

Kolshet, Thane,

India

Anti-TB formulations

Approved by WHO-Geneva and Sandoz

Global

K D Datar

Nicholas Piramal,

Mahad, India

Renovation of oral solid dosage forms M V Jog

Nicholas Piramal,

Hyderabad, India

Topical local anaesthetics M V Jog

Nicholas Piramal,

Pithampur, India

Renovation of oral solid dosage forms facility M V Jog

Erica Pharma, Goa

India

Oral solid dosage M V Jog

Shreya Biotech

Pvt. Ltd. Pune,

India.

Validation of multiproduct biotech facility

jointly with M/s Sheppard Process UK

M V Jog

Biofarm, Romania Qualification of Process Equipments M V Jog

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Resume of Key Personnel

Academic Qualification

Indian Navy – 1957-1960

Mechanical and electrical engineering

Royal Navy, UK -1960-61

Aircraft Electrical and Instrumentation Engineering

University of Mumbai- 1971

Diploma in Business Management

Industrial Career

1971-1993

Roussel, India

Manager- Projects and Engineering.

He was responsible for setting up the green filed Roussel Multi Dosage Forms facility

near Mumbai, India in 1976 and all expansion projects thereafter.

K.Y. Chandgude Engineering, Finance and Administration

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Consulting

1. M/S Gland Pharma Ltd., Hyderabad, India. (1995)

Injectables facility Approved by MHRA.

2. Encube Ethicals Pvt. Ltd., Mumbai, India. (1997)

Ointments & Creams Manufacturing Facility.

3. Novartis Enterprises Pvt. Ltd., Thane, India. (1998)

R & D: formulations

4. Novartis Enterprises Pvt. Ltd., Thane, India. (1999)

Cephalosporins, oral solid dosage forms.

5. Septodont Healthcare Ltd. Mumbai, India (1998).

Dental formulations facility for a French company.

Current Responsibilities

Founder partner of Technolutions with Mr. P.K.Kulkarni, he now looks after the entire

finance, legal and administration functions.

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Department of Pharmaceutical Sciences, Nagpur University, India.

M.Pharm

Bharatiya Vidya Bhavan, Nagpur

Diploma in Business management

Awards

IDMA G.P.Nair Gold Medal

For standing first at the University, B.Pharm. 1980

Prof. M.L.Schroff Gold medal

For standing first among all the Universities in India, B.Pharm, 1980

S.A. Vali memorial Gold Medal

For standing first at the University, B.Pharm. 1982

Industrial Career

1982-1984 : Almet Corporation, Aurangabad, India

Manufacturing Chemist

Pramod Kulkarni

Oncology and Biotech Facility Design, Containment & Regulatory Compliances

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1984-1989: Sandoz Ltd., India

Production Officer- Injectables

1989-1994: Roussel, India

Assistant Manager- Manufacturing, Project Manager- MRP II System (PRODSTAR)

1994-1999: Merind Ltd., Mumbai

General Manager- Manufacturing, responsible for in house and contract manufacturing ,

packaging development and projects.

1999-2000: Wyeth Ltd.

Associate Director, Manufacturing responsible for all manufacturing operations including

contract manufacturing.

Consulting

2001 – 2006: Mott MacDonald, India

(See Table for details)


Founder partner of Technolutions with Mr. K.Y. Chandgude, he now undertakes the

following major work responsibilities.

I. Facility design for all oncology and biotech facility projects undertaken by

Technolutions.

II. Business Development – Formulation Projects

III. Finalizing basis of design and process sizing.

IV. Basic Engineering including concept development, layouts, process equipment

specifications and allied work.

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University of Mumbai

Dip. Mech. Engineering

Industrial Career

1982-2005: Sandoz India Limited.

Deputy General Manager- Engineering and Projects

He was the project manager for a number of projects undertaken by Sandoz during his

tenure.

The main projects were as under.

Formulations Development centre, Thane, India (1999)

Cephalosporins Formulations Project (2001)

Oral Solids Dosage Forma Facility, Kalwe, India. (2003)

Anti TB formulations facility, Kolshet, India. (2001)

Consulting

2001 - 2006

Mott MacDonald, India


Kishore Datar

Engineering, Basic & Detailed For all dosage forms

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Membership of technical bodies / institutions:

• ISPE (International Society Of Pharmaceutical Engineers).

• ASHRAE (American Society of Heating, Ventilation & Refrigeration Engineers) –

Member of BOG ( Board Of Governance – Western chapter for 2006 – 2007 year)

• Ultra Pure Water Society of USA - Pure Water.


Joined Technolutions in 2005 to take up the entire responsibility for basic and detailed

engineering as well as qualification of clean utility systems.

He now undertakes the following major work responsibilities.

I. Review of facility design for GEP, GAMP and GXP compliances from

engineering perspective.

II. Basic and detailed engineering of all disciplines including electrical, mechanical,

HVAC, clean utility systems and project co-ordination.

III. Training and qualification of clean utility systems.

IV. Co-ordination with outsourced engineering work mainly civil and structural.

V. Project Cost Estimations.

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Panjab University, Chandigarh, India

M.Pharm.

Teaching Experience

1982-1983: College of Pharmacy, Solapur

Lecturer in Pharmaceutics and Pharmaceutical Chemistry.

1985-1986: College of Pharmacy, Nashik

Honorary Research Guide- Pharmacology.

Industrial Career

1983-1995: Glaxo India Ltd., Nashik

Executive-Production

Responsible for manufacturing management of Tablets, Liquid Orals, Ointments, Sterile

Ointments and Metered Dose Inhalers.

1995-2002: Glaxo Saudi Arabia Ltd., Jeddah, Saudi Arabia.

Manager- Production

Responsible for manufacturing management of Tablets, Liquid Orals, Ointments,

Cephalosporin Tablets and Powder Injectables.

Milind Jog

Validation Services

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Consulting

2002 – 2007 : Mott MacDonald, India



Joined Technolutions in 2007 to take up the entire responsibility for validation services for

facilities designed by Technolutions as well as other facilities.

In addition he does extend his services for facility design, process engineering and training

projects.

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Department of Pharmaceutical Sciences (1982)

M.Pharm.

Industrial Career

1982-1985 : Almet Corporation, Aurangabad, India.

Senior Pharmacist-Production

Responsible for manufacturing management of Liquid Injectables and Liquid Orals

1985-1987 : Wockhardt Ltd., Aurangabad, India.

Officer- Production

Responsible for manufacturing management of liquid Injectables.

1987-1990 and 1996-2000 :Aditi Pharma (subsidiary of CIPLA Ltd.), Solapur, India.

Plant Manager

He was responsible for the total manufacturing management of non cytotoxic liquid

Injectables as well as cytotoxic liquid and lyophilized injectables.

Ajit Kanetkar

Process Engineering & Business Development

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1990-1992 : Concept Pharma Ltd., Aurangabad, India.

Executive-QA

Responsible for plant based QA systems installation and preventive maintenance.

1992-1996 : S.M. Pharmaceuticals Sdn Bhd., Malaysia.

Plant Manager

Responsible for the total management of Formulations

Manufacturing including tablets, ointments, liquid orals, and liquid injectables. The

responsibilities involved materials, manpower recruitment, training and management,

production management, formulation development, product registration with local

authorities and support to QC.

2000-2007 : PamGlatt Pharma Technologies Pvt. Ltd.

Joint Venture company of ACG Worldwide & Glatt International of Germany

Head- Process Technology and Customer Support.

Responsible for

o Technical marketing & technology promotion. Selling the concept of fluid bed

processing in the Indian Pharma industry

o Entire Service function involving coordination of installation of machines, service,

AMCs and spares. Established this function in the company.

o Orgainising training programs for users

o Process support: process optimizations

o Monitoring and directing of QA interfaces in machine building and all associated

activities.

o Interphasing with Design dept

o Relations with customers

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Joined Technolutions in December 2007 to take up the entire responsibility for process

engineering including qualification of the process equipment and systems.

He will also provide his services for process sizing, facility design, review of discipline

engineering and business development

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