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A balanced ecosystem is our key to sustenance 25 years of excellence in agrochemical development

balanced ecosystem is our key to sustenance - Advinus a pioneer in agrochemical development ... and new generation formulations ... • Technology transfer for commercial production

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A balanced ecosystem is our key to sustenance

25 years of excellence in agrochemical development

At Advinus, we believe in adding continuous value to a more greener & healthier environment through responsible & quality agro R&D, Product Life Cycle Management and global registrations. Being a pioneer in agrochemical development for 25 years in India, has helped us gain valuable insight & immense experience to be your reliable partner for complete Agro Lifecycle Management Solutions.

Why partner with Advinus?• Management and scientific leadership team with extensive international experience

• Leading center for regulatory toxicology with the largest animal vivarium in South Asia

and one of Asia’s largest REACH testing facilities

• Experience of over 5,500 successful regulatory GLP submissions and over 1,000 Phys

chem studies

• More than 17 successful audits by global and regional regulatory agencies

• Data generated at Advinus successfully accepted by EPA and OECD countries

• State-of-the-art Pilot plant dedicated to Process Development and Process Validation of

Active Ingredients

Accreditations & Guidelines: • GLP, OECD, US-EPA, CIPAC, EEC, FAO

• NGCMA India

• W&V Netherlands

• Atomic Energy Regulatory Body, Government of India

• BfR Germany

• AAALAC

Infrastructure:• 220,000 Sq ft

People: • 450+

Advinus Agrochemical Development Services

Process Chemistry

• 5-Batch Synthesis

• Custom synthesis of intermediates, exotic raw materials, impurities/metabolites

• Route scouting & identification for generic AI’s

• Process Development and Optimization of Novel and/or Non-infringing routes

• Complete process analytical package including impurity profiling

• Process Scale up

• Asymmetric synthesis, chiral separations

• Technology transfer services

• Patent technical specification preparation and filing of patents wherever applicable

Analytical Chemistry Capabilities

• Structural characterization

• Impurity profiling

• Analytical method development and validation

• Preparation of reference and working standards

Genetic Toxicology

• Bacterial Mutation Assay

• invitro mouse lymphoma

• invitro cytogenetic assay

• invivo erythrocyte micronucleus assay

• invivo bone marrow metaphase assay

• Preparation of reference and working standards

General Toxicology Rodents

• Single-doset acute (including oral, dermal, inhalation, irritation and sensitization tests)

• Repeated dose sub-acute and sub-chronic studies

• Chronic toxicology studies

• Carcinogenicity studies

Full range of reproductive and developmental toxicity studies required for product registration• ReproductivetoxicologyscreeningtoOECD

421and422

• Developmental toxicology in rats and rabbits

• Multigenerational studies in rats

• Avian Reproduction studies

Non-Rodent Toxicology

• Single dose studies

• Dose escalation study maximum tolerated dose

• Repeated dose

• Chronic toxicology

ADME Studies• Studies in rodents including mass balance,

tissue distribution in cold and radiolabelled compound and metabolite identification

Analytical Capabilities

• Method development/ validation for active ingredients in different substrates

• Sample analysis for Eco-Toxicology, Air- Inhalation and Toxicology studies

• ADME support

Residue Analytical • Physical & Chemical properties for Technical

AI and Agro-formulations

• Method Development & Validation

• Residue & Persistence in Soil, Water & Plants (as per GAP & GLP or Non GLP)

5 Batch Analysis

• Technical material analysis for AI and impurities ≥0.1%

Physico-chemical studies• Melting/freezing point

• Boiling point

• Relative density

• Surface tension

• Water solubility

• Partition co-efficient n-octanol/water

• Flash-point

• Flammability

• Oxidising properties

• Stability in organic solvents and identity of relevant degradation products

• Dissociation constant

• Viscosity

• Photolysis studies

• Explosive properties

• Auto ignition

• Self ignition

E-fate Studies

• Hydrolysis as a function of pH

• Aqueous Photolysis

• Adsorption Co-efficient by HPLC

• Adsorption/Desorption in Soil by Batch Equilibrium

• Radiolabelled studies

• Persistence Studies (Field & Lab)

• Residue Studies

• Biodegradation

• Ecotox studies in fish, daphnia, algae and honeybees

Other Services

• Authentication of Test Item and Issuing COA

Agro Formulation

• Formulation recipe development of conventional and new generation formulations

• Improvement of existing formulations

• Development of combination formulations

• Selection and recommendation of the right type of formulation for development

• Stability studies accelerated and multi-locational storage

• Supply of samples for field trials and for toxicological studies

• Pilot plant scale up studies and process optimization

• Technology transfer for commercial production

Field Trial Support

• Plant analysis for the nutrients

• Soil analysis – physical & chemical properties

• Water analysis on post field trials

• Fertilizer analysis for major & micro nutrients

Advinus Agrochemical Development Services

Process Chemistry:

• 40,000sq.ft.labwithfacilitiesforCryo{(-)1000C},hightemp{(+)2200C},Highpressure&Hydrogenationreactions

• 10Reactors–20LAGR,200LSSRwithcapacitiesof20Lto650L

• Dedicatedinfrastructureforradiolabeledcompounds

• Teamincludes56scientists(14PhDs,37Masters)

Safety Assessment:

• Over70,000sqft.lab

• Speciesavailable:Rats,Mice,Guineapigs,Rabbits,Chicken,Pigeons,Quail,Freshwaterfish,Algae,Daphnia,&Honeybees

• Teamincludesaround108scientists(10PhDs,8DABTs)

Analytical R&D:

• Labarea:approx.4000sq.ft.withseparatefacilityforradiotracerstudies

• Teamincludes25Researchscientists(2PhDsand20Masters)

• EquipmentsincludeLC-MS/MS(API2000,API4000),GC-MS,HPLC-UV/PDA/-RAM,andGC-ECD/NPD/FID,SuntestApparatusandinstrumentsforPhys-Chemstudies

Agro-Formulations:

• 2000sqftofdedicatedlaboratorywithnecessaryequipmentslikeribbonblenders,airjetmills,dynomills,extruder,homogenizerandspraygranulator

• 500sq.ftofdedicatedpilotplantsforscale-upexperiments

• Full-fledgedanalyticallaboratorieswithGCs,HPLCs,viscometer,KFtitrators,UV-VISspectrophotometers

Advinus Infrastructure

© 2013: ADVINUS

[email protected]