corporte presentation 2017 - symphony pharma · corporte presentation 2017 symphony pharma life...
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An ISO 9001-2008 Certified Company
DSIR Recognized R&D Facility
D&B D-U-N-S® Number 65-061-8049
-Chemistry for Humanity-
CORPORTE PRESENTATION 2017
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
ABOUT US
-Chemistry for Humanity-
Established in 2008 by Pharma industry experts
Technology driven organization with a flexible approach. Founded by scientists with proven industrial track record
Expertise in Process Research/Development and scale-up (non-GMP and cGMP)
Research partner for Innovator/Generic Pharmaceutical and Biotech companies across the globe
• “TO ENHANCE VALUE BY PARTNERING WITH GLOBAL PHARMACEUTICAL INDUSTRY ACROSS ITS VALUE CHAIN”
VISION & MISSION
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
Mr. Amar Reddy - MD /Co-Founder
Has 20+ years of experience in the technology field for organizations such as (AT&T), (Hoffman-LaRoche) & (Marsh &McLennan, Merrill Lynch). Co-founder of Invagen Pharmaceuticals (LongIsland, NY).
LEADERSHIP TEAM-KEY MANAGEMENT
Dr. Raju Sirisilla – COO/Co-Founder
Has 20+ years of experience in the pharmaceutical industry – With Symphony for 8 Years, Well
recognized for Process research & development from bench scale to plant commercial scale (NCE’s,
API’s / Intermediates) & Regulatory filings, Worked with organizations such as Dr. Reddy’s & Laurus
Labs.
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
TEAM
PhDs 15%
Masters
82%
Others 3%
QUALIFICATON-WISE BREAK-UPMore than 90% are technically qualified
Team members with Qualification of Ph.D, MSc and Engineering
Scientific collective experience of over 100 years
Extensive Synthetic chemistry, Analytical & Manufacturing skills
Scientific advisory board members from well-known institutes in US & India
Employee welfare at Symphony boasts of attracting & retaining skilled talent
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
BUSINESS FOCUS:
Contract Research(Full-Time Equivalent - FTE)
Custom Synthesis (Fee For Services-FFS)
Product Development (Process & Analytical)
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
Contract Research Services
(Full-Time Equivalent - FTE)
Efficient/ Experienced Manpower
Deliverables up to 1000g
Competitive pricing
Integrated project management
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
Contract Research Services
(Full-Time Equivalent - FTE)
Inclusions
• Manpower cost
• General chemicals, Solvents, Reagents & other low cost materials.
• In-house Analysis (HPLC, HPLC-GC, UV, FTIR, KF) & Analytical method development
• Literature search, communications & project management
Exclusions
• Key Starting Materials & Rawmaterials
• External analysis such as 1H NMR, 13CNMR, LCMS, CHN, XRD, Mass Spec analysis etc.
• Special requirement
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
Custom Synthesis
(Fee For Services)
Adherence to strict timeline
Adherence to specifications
High quality
Short turn around time for enquiries
Lab to commercial scale
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
PRODUCT DEVELOPMENT ( Process & Analytical)
Rigorous Literature evaluation
Regulatory Implications
study
Cost effective & environment
friendly process/ROS
Robust & scalable process
IP generation
&
patent filings
Complete
tech-pack preparation
Access to exclusive market
opportunities
CMC documentation
support
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
CHEMISTRY SERVICES
• Synthesis of building blocks, scaffolds & analogues/libraries of NCE’s
• Developmental work for NCE compounds.
Early phase Discovery/Med.chem
• Synthesis & supply of non-catalogue compounds at all scales
• Advanced Intermediates & key starting materials
• Fine & Speciality chemicals
• Working standards , Impurities & Metabolites
Custom Synthesis (mg to multi kg)
• Exploring all the synthetic routes/ selection
• Process Development, Optimization & Validations
• Non-infringing route developmentProcess R&D
• Analytical method development, Validations & Transfer
• Stability Study : Accelerated & Long term
• Impurity profilingAnalytical R&D
• Supply of NCEs up to Phase-I clinical trials including CMC documentation
• Supply of Advanced intermediates , Fine & Specialty chemicalscGMP Kilo Lab < 25 kg
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
Route Scouting
Quick process development to provide
proof of concept
Optimization for a robust and scalable
process
In-process controls
Process validation and scale up studies
Preparation of standard samples &
impurities
Technology transfer to manufacturing
sites
Stability testing and Degradation studies
Solid state studies
• Multi-step chiral synthesis
• Chiral resolution
• Carbohydrate chemistry
• Amino acid chemistry
• Peptide synthesis (solution
phase)
• Bio-transformations
• Suzuki Coupling, Heck Coupling
and Sonogashira Coupling
• Grignard reaction
• Borane / Diborane chemistry
• Carbonylation
• Swern Oxidation
PROCESS R&D STRENGTHS-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
Method development & validation
Specification development
Impurity profiling
Stability testing and Degradation studies
Release of products with COA
Qualification of working standards/Reference standards
Spectral characterization by NMR, IR, LCMS
Solid state characterization by XRD, DSC, IR
Support to regulatory filings
ANALYTICAL R&D STRENGTHS -Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
• Capacity - 5 to 10 tons per month
• Pressure reactions (10-18kg/cm2)
• Temperature range from -70 to +200 deg C
• Homogenous and Heterogeneous Hydrogenation
• QC, QA and EHS practices as per norms
• Handling the air / moisture sensitive reagents (Grignard, Friedel crafts acylation, n-BuLi, Sonogashira couplings and silylation reactions)
• Reducing agents (LAH, NaBH4 etc.)
• Pyrophoric chemicals (Sodium hydride, Raney Ni etc.)
• Flammable gases like ethylene oxide, Hydrogen gas & pressure reactions
• Meeting all applicable regulatory requirements and
quality standards.
MANUFACTURING STRENGTHS-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
PROCESS R&D INFRASTRUCTURE
New 50,000+ sq. ft approved research facility on a 2+ acre
lot located in Research & Knowledge park (Biotech park)
in Hyderabad
25,000 Sq. ft. in operation
Room to scale with 25,000+ sq. ft. expansion planned
Fit-for-purpose R&D labs with 18+ fume-hoods
Working space for 50 Scientists
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
-Chemistry for Humanity-
ANALYTICAL R&D INFRASTRUCTURE
HPLC system, Waters 2695
HPLC System, Agilent
GC & GC-HS System, Agilent
FT-IR Shimadzu 8400S
UV Shimadzu 2450
Karl-Fischer titrator
Melting point apparatus
TLC Chambers
Water purification system (TKA)
Stability Chambers (Accl & LR)
Muffle Furnace
LC-MS (in process of procurement)
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
cGMP KILO LAB INFRASTRUCTURE
500 Lt- SSR
250 Lt-SSR
100 Lt-SSR
250 Lt- GLR
100 LT-GLR
Vacuum tray drier (25-50 Kg drying in single slot)
Blender
Miller
Oil freed boiler
Chiller
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
ASSOCIATE MANUFACTURING FACILITIES-
INFRASTRUCTURE
• FDA approved facility
• Finished product in ISO-8 environment
• Reactors GLR and SSR
• High pressure hydrogenator
• Support equipment - Centrifuges,
Millers, Sifters and Dryers
•Manufacturing capacity: 56 KL
•Maximum size of reactor: 5 KL
•Minimum size of reactor: 500 L
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
PM: PROJECT INITIATION
TECHNICAL
INFORMATIO
N PACKAGE
BASELINE
PLAN
CONFIDENTIALI
TY
AGREEMENT/
SECRECY
AGREEMENT
REACTION
SCHEME
PURCHASE
ORDER
STARTORDER
CONFIRMATION
OFFER(COST
TIMELINES,
TERMS &
CONDITIONS)
PROJECT
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
PRODUCTS: APIs & INTERMEDIATEs
Lacosamide
(US DMF Ref 26594)Bazedoxifene Mirabigron Cinacalcet
Dabigatran Etexilate
Dronerdarone Flupiritine Vemurafenib
Plerixafor
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
PRODUCTS: API-IMPURITIES
• Bazedoxifene
• Mirabigron
• Dronedarone
Hydrochloride
• CinacalcetHydrochloride
• Lacosamide
• Dabigatran Etexilate
Mesylate
• Asenapine
• Desloratadine
• Valsartan
• Atorvastatin
• Bazedoxifene
• Irbesartan
• Olmesartan
• Ranolazine
• Lurasidone
• Lansoprazole
• Fluconazole
• Ramipril
• Eslicarbazepine
• Carvedilol
• Rosuvastatin
• Eszopiclone
• Valganciclovir
• Oxaprozin
• Amlodipine
• Linezolid
• Escitalopram
Oxalate
• Famotidine
• Solifenacin
• Vilazodone
• Lamotrigine
• Sitagliptin
• Ezetimibe
• Linagliptin
• Voriconazole
• Saxagliptin
• Agomelatine
• Tolterodine
• Zafirlukast
• Pemetrexed
• Lenalidomide
• Nateglinide
• Pregabalin
• Enalapril
• Bicalutamide
• Montelukast
-Chemistry for Humanity-
PRODUCTS: BUILDING BLOCKS
Bicyclo compounds
Azaindoles Thiophenes Quinoxalines
Pyrazoles Imidazoles Pyridines Pyrimidines
BenzaxozolesBenziimidazoles and many more
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
Some
of Our
Valued
Clients
-Chemistry for Humanity-
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
7/A, Biotech Park, Phase - II
Genome Valley, Shamirpet,
Hyderabad - 500 078, Telangana, India
TEL: USA +1 609.269.2700 | INDIA +91 9550867444
Website: www.sympharma.com
103 Morgan Lane, Suite#104
Plainsboro, NJ – 08536, USA
Symphony Pharma Life Sciences, TEL: +1 609.269.2700 | +91 9550867444, Email: [email protected]
-Chemistry for Humanity-