5/6, Ramkrishnanagar, Off E.E.Highway, opp. Hotel Sharanam, Thane (W). 40060, Maharashtra State, India Telefax: +91-22-25811244, E mail: [email protected]
Page 1 of 24
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.
Page 2 of 24
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
Page 3 of 24
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 Concept development
o Basic engg.
o Detailed engg.
o Validation support
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
Page 4 of 24
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 Concept development
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 Concept development
o Basic engg.
o Detailed engg.
Concept
Development &
Basic engg.
completed. Civil
work expected for
completion by
August 2008
Page 5 of 24
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 Concept development
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 Concept development
o Basic engg.
o Detailed engg.
o Procurement assistance
o Site supervision
o Validation support
Basis of design
under discussion.
Hebei Changshan
Biochemical
Pharmaceutical
Co Ltd, China
Review of existing
facility
Technical due diligence Review and report
completed.
Page 6 of 24
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 Concept development
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 Concept development
o Basic engineering
o Validation
Page 7 of 24
Completed Projects (Technolutions) (Contd.)
Client Category Scope of Services
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 Concept development
o Basic engineering
Reliance Life-Sciences,
Navi Mumbai, India
Yr : 2006
Biotech derived injectables o Concept development
o Basic engineering
o Detailed engineering
Page 8 of 24
Completed Projects (Technolutions) (Contd.)
Client Category Scope of Services
Oros Pharma, Jammu, India
Yr: 2006
Oral solid dosage o Concept development
o Basic engineering
o Detailed engineering
Emcure Pharma,
Pune, India
Yr: 2006
Oncological injectables o Concept development
o Basic engineering
o Detailed 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
Page 9 of 24
Completed Projects (Technolutions) (Contd.)
Client Category Scope of Services
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 Concept development
o Basic engineering
o Detailed engineering,
o Site supervision
o Training for
Validation
Page 10 of 24
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
Page 11 of 24
Projects done for Mott MacDonald (Contd.)
Client Category Project Leader
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
Page 12 of 24
Projects done for Mott MacDonald (Contd.)
Client Category Project Leader
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
Page 13 of 24
Projects done for Mott MacDonald (Contd.)
Client Category Project Leader
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
Page 14 of 24
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
Page 15 of 24
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.
Page 16 of 24
Academic Qualification
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
Page 17 of 24
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)
Current Responsibilities
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.
Page 18 of 24
Academic Qualification
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
(See Table for details)
Kishore Datar
Engineering, Basic & Detailed For all dosage forms
Page 19 of 24
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.
Current Responsibilities
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.
Page 20 of 24
Academic Qualification
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
Page 21 of 24
Consulting
2002 – 2007 : Mott MacDonald, India
(See Table for details)
Current Responsibilities
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.
Page 22 of 24
Academic Qualification
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
Page 23 of 24
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
Page 24 of 24
Current Responsibilities
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