Vishwa-Syntharo PharmaChem Private Limitedvishwa-syntharo.com/pdf/Vishwa-Syntharo-PharmaChem...High...
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Vishwa-Syntharo PharmaChem Private Limited
December 2015
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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.
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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
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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
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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.
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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
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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
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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
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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
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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
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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
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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.
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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
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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
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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
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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
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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
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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
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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
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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
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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