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Vishwa-Syntharo PharmaChem Private Limited
December 2015
Background - Vishwa
• The name “Vishwa” originates from two Sanskrit words: Vishwas (Trust) & Vishwam (Global)
• Founded and whole-time managed by Dr. Sankara Subramanian with more than three decades of experience in leading pharmaceutical and chemical organizations in India
• Incorporated in March 2010 for providing chemistry and related services to the pharmaceutical and fine chemical industry
• Moved operations to Sri Ramachandra University, Chennai in October 2012 through a collaborative arrangement
• Collaboration forged with ProVentus Life Sciences, Chennai in December 2013 to have access to kilo and large-scale manufacturing
• Entered into a Joint Venture with Syntharo Fine Chemicals, Germany in September 2015.
Background - Syntharo
• Incorporated in April 1998 for the sale of fine & specialty chemicals
• Over the years, the company has developed into a manufacturer of intermediates , which are needed primarily for the synthesis of agrochemical & pharmaceutical ingredients (APIs ) and are used in cosmetic formulations
• 2005 – 2010, located at Leverkusen CHEMPARK
• In 2010, relocated to Industrial Park Troisdorf located between Cologne and Bonn , the former location of the Dynamit Nobel
• Involved in production of specialties on a laboratory scale
• Customers include catalogue companies, R & D departments of research-intensive chemical companies
• Other offices are located at:
Syntharo Fine Chemicals India Private Limited, Mumbai, India
USA – Syntharo Fine Chemicals USA Inc. New York, USA
Mission & Vision
Mission
Be a TRUSTWORTHY provider of products and services provider to the
Pharmaceutical and Speciality / Fine Chemical industry in all its fields of
operations
Vision
To be GLOBALLY renowned for excelling in Quality of Work, Integrity,
Innovation, Businesses processes, Technologies developed and Services
offered
Quality Policy
QUALITY POLICY
At Vishwa-Syntharo PharmaChem we shall continuously strive to provide our customers the best and timely delivery of products and services, through:
� Continuous improvements to our business processes;
� Developing and using the most appropriate technology that is efficient, cost effective and has least impact on environment;
� Maintaining a transparent and timely communication chain with the customer;
� Deploying appropriate human resources for the projects and continuously upgrading their skill and efficiency levels through periodic training and mentoring.
Dr R Sankara Subramanian
Education:
B.Sc – Vivekananda College, Chennai; M.Sc – Loyola College, Chennai
Ph.D – IIT Madras (Chennai); Post Doctoral – Univ. of Bath, UK
Previous work experience:
Recon Limited (now Hikal) -Establishment of Research Laboratories
-Process development for APIs
Shasun Chemicals & Drugs - Head of R&D
- Head of Corporate Quality Assurance & Regulatory
Affairs
- Strategic Business development
- Structure and commission CRAMS activities
Sanmar Speciality Chemicals
/ ProCitius Research
- Establish and lead the API division through FDA
inspection
-Establish and manage the Contract Research division –
ProCitius Research
ProVentus Life Sciences -Co-investor
-Restructure of business activities
- Establish and manage API and CRAMS business activities
Lars Müller
Background:
Founder and Director of Syntharo Fine Chemicals GmbH since 2008
Others:
CEO, Chem-Trade & Consulting GmbH, 1998 – 2007
Raimund Müller GmbH & Co. KG, 1993 - 2006
Research Advisor
Prof K K Balasubramanian
Education: PhD: University of Madras
Post Doctoral: Wayne State University, Detroit
(Amino- and keto- sugars with Prof Carl Stevens)
Background: Dept. of Chemistry, Indian Institute of Technology Madras
(1971 – 2001)
Industrial : Executive Director, R&D, Shasun Chemicals and Drugs (2001 – 2011)
Currently: Visiting faculty at Sri Ramachandra Univ. and Abdur Rahman Univ.
Expertise: Synthetic Organic Chemistry
Molecular rearrangements
Organic photochemistry & Electro-organic chemistry
Carbohydrate chemistry
Publications: 150
Students guided for PhD: 32
Key Awards: Lifetime achievement award CRSI Gold Medal 2012
Fellow of the Indian Academy of Sciences
Business Associate
Dr. K Vijayakumaran
Education:
M.Sc – University of Madras (Chennai);
PhD & Post Doctoral Research – University of Nancy (France)
Areas of Expertise:
Carbohydrate Chemistry - Synthesis of mono and polysaccharides
- Deuterated sugars
Oxidation reactions Chromium based reagents in organic oxidation of
complex organic molecules
Multi-step organic synthesis Several compounds synthesized for laboratory
chemical companies
Areas of Focus & Services
CustomManufacturing
(APIs, Fine &
Specialty chemicals)
ProcessDevelopment
(Fine / Specialty
Chemicals /
APIs)
Scale-upOf
Technologies
CustomSynthesis
(Fine / Specialty
Chemicals /
APIs)
AnalyticalServices
Chemistryfor
DrugDiscovery
Custom Synthesis:
� Develop process
� Scale-up to make required quantity of chemical (grams to multiple of kilos)
Process Development:
� Development of processes for hard-to get molecules
� Scale-up and supply can be made in-house or technology can be licensed to
second- or third-party
Chemistry for Drug Discovery:
� Synthesis of customized libraries
� Synthesis of targets
� Lead optimization (with provided inputs)
Analytical services:
� Analytical method development
� Synthesis and characterization of hard-to-get impurity standards
Scale up of Technologies:
� In-licensing of laboratory scale processes, fine-tuning them and scaling up to
make larger quantities as required
Key Chemistry Capabilities
Asymmetric
Synthesis
� Chiral alkylation
� Asymmetric Dihydroxylation,
� Sharpless, Heck Epoxidation
Oxidation � Classical (Jones, KMnO4, CrO3, MnO2 etc)
� Swern
� Moffat
� Corey-Kim
� Transition Metal Catalyzed
Reduction � Metal Hydrides
� Homogeneous & Heterogeneous catalysed
� Transfer Hydrogenation
� Dissolving Metal Reduction
Others � Fluorination (NFSI, DAST, selectfluor, deoxo-fluor)
� Carbonylation
� Cyanation
Organometallic � Heck arylation
� Suzuki coupling
� Sonagashira coupling
Chemistries that we do not handle: Reactions involving Phosgene; HCN gas
Common chemistries regularly performed is not included in above.
Carbohydrate Chemistry
Basic monosachharidesDifferentially protected and derivatized monosaccharides
PolysaccharidesTypically di- and tri- saccharides
Protected amino-sugars
Such as (D)-Glucosamine
Configurational inversion
Such as SN2-displacement or oxidation-reduction sequence) to arrive at rare
sugars
Carbohydrate-derived chiral synthons
Performing sequential chemical transformations on the chiral-pool derived from
sugars to make chiral synthons
O
H
AcO
OAc
H
H
Br
OAcHH
OBn O
H
H
HO
H
OH
OHHH
OH
O
H
HO
H
HO
H
O
OHHH
OH
OH
H
H
H OH
HO H
O
H
HOHO
Fluorine Chemistry
Fluorinated chemicals
Custom synthesis of:
• Fluorinated starting materials
• Fluorinated intermediates
• Fluorinated drugs
Typical fluorinating agents used:
• NFSI;
• DAST (at small scale only);
• Selectfluor; deoxo-fluor
S S
N
F
O
O
O
O
N
SF3
CH3 CH3
H3CO
N
OCH3
SF3N
N
Cl
F
2 BF4
COOHF
O
FFF
CF3
F
Chiral chemistry
� Resolution of compounds by chemical method
� Asymmetric / enantioselective synthesis
� Steroselective synthesis using enzymes
Chiral purity estimated by:
� Chiral HPLC
� Optical rotation
� NMR using chiral shift reagents
Research & Development
Fume Hoods: 5 (in Phase 1)
Rotary evaporator Buchi 4 nos.
Scale: 5 ml to 10 litres
Temperature range: - 70 to + 250 deg C
Vacuum: Double-stage water-ring vacuum: 60 mm 1
Diaphragm pump: 10 mm 2
Oil vacuum pump: 0.1 mm 4
High pressure 250 ml SS 316 shaker Temp: Ambient to +250 C
Pr.: Ambient to 30 Kg
2
5 lit Temp: Ambient to +250 C
Pr.: Ambient to 30 Kg
1
10 lit SS 316 *
Capabilities: � Column chromatographic purification
� Fractional distillation
� Cryogenic reactions
� Organo-metallic reactions
* - Under procurement
Analytical
GC: Under procurement
GC-HSS: Under procurement
GC-MS: Perkin Elmer Claruss 600 GC with 600 C MS(Outsourced from Ramachandra Univ. / VClinBio; turn-around time 12 - 36 hrs)
HPLC: Shimadzu LC-2010
Shimadzu LC-2010A HT
Shimadzu LC-8A
NMR: Bruker 400 MHz (Outsourced from Ramachandra Univ. / VClinBio; turn-around time 12 - 36 hrs)
HPTLC: CAMAG-ATS-4(Outsourced from Ramachandra Univ. / VClinBio; turn-around time 12 - 36 hrs)
LC-MS: Agilent
FT-IR: Under procurement
UV-Vis: Under procurement
Auto-titrator: Under procurement
Kilo-lab 1
Low-level fume hoods for 20 liter flasks 2
100 Lit all glass unit 2
20 Lit fractional distillation 1
20 Lit Rotary evaporator 1
Vacuum tray dryer (4 trays / 5 to 10 kgs) 1
Nutsche filter (PP) 1
Air quality:Air conditioned Clean area (Not classified)
Operation conditions:Temperature: -70 to + 250 deg CVacuum: 1 mm HgPressure: Ambient
Kilo-lab 2
250 Lit reactor (SS 316) 1
250 Lit reactor (MS-GL) 1
Centrifuge (SS 316) (36”) 1
Nutsche filter (PP) 1
Vacuum tray dryer (6 trays / 10 to 25 kgs) 1
Multi-mill 1
Sieve shaker 1
Operation conditions:Temperature: -15 to + 150 deg CVacuum: 1 mm HgPressure: Ambient
Air quality:Filtered airClass 100,000
Key Achievements of Vishwa-Syntharo
Target No of
steps
Other
Manufacturers
Status Customer
Fine chemical
for New API
2 Limited API just approved
Under commercial prodn.
MNC Pharma
Intermediate
for API
2 Limited Production to start MNC Pharma
CONTACT
Registered Office:
32, First Main Road
CIT Colony,
Mylapore,
Chennai – 600004
Tamil Nadu, India
[email protected] www.vishwa-syntharo.com
R&D:
2C Dr. Subramania Siva Salai
CMDA Industrial Estate
Maraimalai Nagar
Chennai 603 209
India
Vishwa-Syntharo PharmaChem Private Limited
Tel: +91 44 43536710
Germany:
Syntharo Fine Chemicals GmbH
Industriepark Troisdorf Geb. 38
Mülheimer Strasse 27
53840
Troisdorf, Germany
Tel: +49 2241 25569-0Tel: +91 44 47431610