CORPORTE PRESENTATION 2017 - Symphony Pharma · CORPORTE PRESENTATION 2017 Symphony Pharma Life...

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


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


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.



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



BUSINESS FOCUS:

Contract Research(Full-Time Equivalent - FTE)

Custom Synthesis (Fee For Services-FFS)

Product Development (Process & Analytical)



Contract Research Services

(Full-Time Equivalent - FTE)

Efficient/ Experienced Manpower

Deliverables up to 1000g

Competitive pricing

Integrated project management



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



Custom Synthesis

(Fee For Services)

Adherence to strict timeline

Adherence to specifications

High quality

Short turn around time for enquiries

Lab to commercial scale



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 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



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-


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-


• 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-


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



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)


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



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



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



PRODUCTS: APIs & INTERMEDIATEs

Lacosamide

(US DMF Ref 26594)Bazedoxifene Mirabigron Cinacalcet

Dabigatran Etexilate

Dronerdarone Flupiritine Vemurafenib

Plerixafor




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


PRODUCTS: BUILDING BLOCKS

Bicyclo compounds

Azaindoles Thiophenes Quinoxalines

Pyrazoles Imidazoles Pyridines Pyrimidines

BenzaxozolesBenziimidazoles and many more



Some

of Our

Valued

Clients



7/A, Biotech Park, Phase - II

Genome Valley, Shamirpet,

Hyderabad - 500 078, Telangana, India

TEL: USA +1 609.269.2700 | INDIA +91 9550867444

[email protected]

Website: www.sympharma.com

103 Morgan Lane, Suite#104

Plainsboro, NJ – 08536, USA



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