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Shree Dhanvantary Pharmaceutical Analysis and Research Centre
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Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

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Page 1: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

Shree DhanvantaryPharmaceutical

Analysis and Research Centre

Page 2: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

Situated inShree Dhanvantary Pharmacy College Campus

Where Industry Meets Academia !

Page 3: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

MISSION

“Validate the Scientific Knowledge through

Commercial Outputs”

Page 4: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

RESEARCH CENTRE OVERVIEW

o Established: 2006o Approved by

o FDCA , India o CPCSEAo Department of AYUSH (In Process)o NABL (In Process)o ISO Certified Contract Research

Organizationo 100 % Research Oriented Unit

Page 5: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

OUR FOCUS

Enable Customer’s Business

Help Customers grow

Help research scholars

Build a strong Industry Academic Network

Page 6: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

FACILITIES

o Chemical department (Wet Chemistry)o Analytical department (CIF)o Animal Facilitation Centreo Toxicological Research Centreo Synthetic Lab (Scale up studies)o Microbiology department with AHUo CADD Lab (Drug Design & Toxicity

Prediction)

Page 7: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

CHEMICAL DEPARTMENT

o Custom Synthesis

o Chemical Assay

o Elemental analysis

o Identification test

o Water content

o Ash value & LOD

Page 8: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

MICROBIOLOGY DEPARTMENT

o Microbial Assayso Validation of the

methodso Sterility Testso BET studieso MIC Studieso Microbiological

Pathologyo Clinical Microbiology

Page 9: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

ANALYTICAL DEPARTMENT

o FDCA approved & ISO certified analytical unit

o Sophisticated instruments like HPLC, GC, AAS, UV, FTIR

o Stability Chambers

o Dissolution Units

Page 10: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

ANIMAL FACILITATION CENTRE

o OECD principals of GLP

o LD 50o NOAELo AHUo Pyrogeno Toxicity Battle

studies

oCPCSEA approved animal facilitation centre.

Page 11: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

SERVICES

Pharmaceutical Analysis

Pharmaceutical Product

development

Quality Assurance Animal Studies

Synthetic Chemistry

Analytical Method

development & validation

DMF & Dossier development

Toxicity Prediction

Services

Page 12: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

PHARMACEUTICAL ANALYSIS

o Raw material testing

o Intermediate testing

o Finish product testing

o Stability studies

o Microbiology

Page 13: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

PHARMACEUTICAL PRODUCTDEVELOPMENT

Pharmaceutical Formulation Development.

Intermediate testing

Analytical Method development and Validation

Stability Studies

Page 14: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

QUALITY ASSURANCE

o We provide consultancy in development of quality assurance unit in pharmaceutical companies.

o Dossier Developments

o Registrations

o Area Monitoring

Page 15: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

ANIMAL STUDIES

o Acute toxicityo Sub acute toxicity o Mutagenicityo Bioassays

o HCGo HMGo Urofolitropino Corticotropin

o Bio efficacy studieso Aquatic toxicity o Eye and Skin irritation studieso Pyrogen Testso Medical Devices Compatibility Studies

Page 16: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

COMPUTER ASSISTED TOXICITY PREDICTION

o We have initiated software based toxicity prediction.

o Software: TOPKAT (Toxicity Prediction by Komputer As­sisted Technology)

Page 17: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

OUR CLIENTSS.NO COMPANY NAMES1 Intas Pharmaceuticals Ltd2 Orchid Pharmaceuticals3 Lyka labs Ltd4 BDR Pharmaceuticals5 Megafine Pharma6 Marck Bioscience Ltd7 Chiron Behring Vaccines Ltd(Novaritise)8 Doshion Veolia Water Solution Pvt.Ltd9 Zandu Chemicals Limited10 Tabelts India Ltd11 Gufic Bio Science12 Apex Healthcare Ltd13 Galpha Labortories Ltd14 Luxica Pharma Inc15 Maxheal Pharmaceuticals Ltd

Page 18: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

OUR CLIENTSS.NO COMPANY NAMES16 Globela PharmaPvt Ltd17 Selvok Pharmaceutical co.18 Meridian Enterprises Pvt.Ltd19 Invert Bio-Med Pharmacuticals20 Alicon Pharmaceuticals Pvt Ltd21 Basic PharmaLife Science Pvt Ltd22 Gulbrandsen Technologies Pvt Ltd23 U Square Life science Pvt Ltd24 Morvel Laborteries Pvt Ltd25 S.Khant Healthcare Ltd26 Intracin Pharmaceuticals Pvt Ltd27 Surgimedik Healthcare Ltd28 Mission Vivacare Ltd29 Prayosha Healtcare Ltd30 Rajat Pharmaceuticals Ltd

Page 19: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

SELECTED TOXICOLOGY STUDIES COMPLETED

o Solifinacin succinateo Darifenacin

hydrobromide,o Desvenlafaxime

succinate,o Paliperidone,o Parecetamol infusion,o Parecetamol i.v,o Ticarcillin &

Tazobactum injection,

o Doripanem,o Citicoline+Mementine,o Citiciline+Piracetam,o Doripenem,o Biapenem,o Pemetrexed Inj,o Paliperidone,o Cinacalcet,o Prasugrel,etc

Page 20: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

ACHIEVEMENTS

Filed two provisional patents in the year 2009 Developed more than 42 DMF’s on various molecules Validated 46 analytical methods for Assay, Rel.

Substances and Residual Solvents Performed about 46 toxicity studies for various

industries Developed 6 formulation with altered/improved

efficacy Consulting 2 API units in the Quality Assurance

department. Working with Valuable Customers to the tune of

200+

Page 21: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

OUR STRENGTHS

o Over Six Years of Experience in Animal Exptmts.o A sophisticated Animal Facilitation Centreo Confidentiality is the routine Practiceo A strong and Experience Pharmacology team.o Separate unit for biochemical and hematological

studieso In­house tissue processing unito Already submitted more than 46 toxicity studies

for DCGI and other regulatory bodieso Allied services like Quantitative Analysis,

Prediction of Toxicity readily Availableo Manpower will never be a concerno More than these

Page 22: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

SDPARC

o SDPARC is ever willing to generate/modify the infrastructural facilities based on its customer needs.

o We believe in growing along with customers and a hand always ahead to learn, innovate and acknowledge the customers.

Page 23: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

ORGANIZATION CHART

Director

Principle Investigator

Pharmacologist

Principle Investigator

Pharmacologist Pharmacologist

QA Officer

QA exucative

Page 24: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations

APPROVED RESEARCH CENTRE

o No. of PG students Guided for thesis: 22o No. of Ph.D. students (Ongoing) : 04 o Major Area of work done by them

o Microbiologyo Biotechnologyo Structural Chemistryo Bio­informaticso Pharmacologyo Computer Aided Drug Design

Page 25: Shree Dhanvantary Pharmaceutical Analysis and Research Centresdparc.com/Template/pdf/SDPARC.281160311.pdf · 2016-01-07 · pharmaceutical companies. o Dossier Developments o Registrations