Suven Life Sciences Limited · NSE:SUVEN
Suven Life Sciences — Suven Nishtaa Pharma Private — Corporate Update (February 2009)
24 slides from Suven Life Sciences's corporate update, February 2009
Slide 1: Suven Nishtaa Pharma Private Limited: A Perspective
SUVEN NISHTAA PHARMA PRIVATE LIMITED A group company of Suven Life Sciences Ltd A Complete Pharmaceutical Services Organization A Perspective
Slide 2: Suven's Business Model
SUVEN’S BUSINESS MODEL Drug Discovery Drug Product Delivery Formulation Lead Clinical Lead Pre Process Custom Development, Chem lib / identification / Clinical Supplies Optimization Clinical Research Synthesis Analytical & comb chem hits characterization Trials Manufacturing regulatory & Packaging S
Slide 3: Suven Nishtaa – Capabilities Overview
SUVEN NISHTAA – CAPABILITIES OVERVIEW 110,000+ sq.ft of world-class infrastructure comprising: • Formulation Development Laboratories • Process Development Laboratories • cGMP Pilot / Small-scale production facilities for Manufacturing and Packing of Exhibit Batches and Clinical Supplies • Dedicated
Slide 4: Capabilities of Suven Nishtaa
of Suven Nishtaa CAPABILITIES
Slide 5: Key Business Verticals
KEY BUSINESS VERTICALS •Generic Product Development • NCE Formulations • Product Development • Clinical Supplies Manufacturing • Clinical Supplies Packaging • Novel Drug Delivery Systems • Analytical Services • Regulatory Management
Slide 6: Product Development: Generic Product Development
PRODUCT DEVELOPMENT CAPABILITIES GENERIC PRODUCT DEVELOPMENT • Preformulation Studies • Formulation Development • Process Development • Process Scale-up • Exhibit / Submission / Pivotal Batches • Technology Transfer
Slide 7: NCE Formulations – Product Development
PRODUCT DEVELOPMENT CAPABILITIES NCE FORMULATIONS – PRODUCT DEVELOPMENT • Preformulation Studies • Formulation Development • Preclinical Product Development • Clinical Formulation Development • Process Development and Scale-up • Manufacture of Clinical Batches • Packing of Clinical Batches • Compara
Slide 8: NCE Formulations - Clinical Supplies
PRODUCT DEVELOPMENT CAPABILITIES NCE FORMULATIONS - CLINICAL SUPPLIES • Manufacture of IND Submission batches • Manufacture of Clinical Supplies, Clinical Placebo batches and Clinical Supplies Packaging for: • Phase – I • Phase – II • Phase - III • Clinical Supplies Packaging for Multiple Blind Stud
Slide 9: Dosage Forms
PRODUCT DEVELOPMENT CAPABILITIES DOSAGE FORMS • Tablets (Coated / Uncoated) • Granules / Powders • Hard Gelatin Capsules • Pellets / MUPS • Syrups • Oral Suspensions • Sterile Products * • Topical Products * *Scale-up capabilities to be created
Slide 10: Special Capabilities for Future
PRODUCT DEVELOPMENT CAPABILITIES SPECIAL CAPABILITIES FOR FUTURE •Cytotoxic Products •Steroidal Products •Any other special requirement
Slide 11: Novel Drug Delivery Systems (NDDS)
NOVEL DRUG DELIVERY SYSTEMS (NDDS) CAPABILITIES TECHNOLOGIES • Orally Disintegrating Tablets • Oral Controlled Release Formulations • Matrix based Formulations • Reservoir based Formulations • MUPS Technology • Pulmonary Drug Delivery • Topical Drug Delivery • Aqueous Solubilization
Slide 12: Analytical Services
ANALYTICAL SERVICES CAPABILITIES • Analytical Method Development • Analytical Method Validation • Impurity Profiling • Stability Testing (Pre & Post Marketing) • Microbiological Testing • Microbial Testing • Preservative Efficacy Testing • Sterility Testing • Endotoxin Testing
Slide 13: Regulatory Management
REGULATORY MANAGEMENT CAPABILITIES • Dossier Compilation • Preparation of Regulatory Responses • Post Approval Regulatory Changes • Compliance Audits • Submission of Annual Reports
Slide 14: Facilities
Process Development Laboratory Instrumentation Laboratory FACILITIES Stability Chambers
Slide 15: Product Development Facilities
PRODUCT DEVELOPMENT FACILITIES • Formulation Development Laboratories – 6 Nos • Process Development Laboratories – 2 Nos • Technology Development Laboratories – 8 Nos • Packaging Development Laboratory • Raw material, Packing material & Product Stores • Stability Testing Area • Equipment Wash Area •
Slide 16: Pilot Plant & Warehouse
PILOT PLANT & WAREHOUSE FACILITIES • Pilot Plant for Solid Dosages • Tablets • Capsules • Pellets • Powders • Granules • Warehouse • Raw Material Stores • Packing Material Stores • Printed packing Material Stores • Sampling & Dispensing Area • Secondary Packing Material Stores • Finished Product Sto
Slide 17: Analytical Facilities
ANALYTICAL FACILITIES • Instrumentation Laboratories – 3 Nos • Dissolution Testing Laboratory • Chemical Testing Laboratory • Solution Preparation Laboratories • Microbiological Testing Laboratory • Oven Rooms • Glassware Washing Room • Cleaned Glassware Storage Room
Slide 18: Others
OTHERS FACILITIES • Stability Chambers • Document Preparation & Storage • Controlled Sample Storage • Document Archival
Slide 19: Quality Assurance Management
QUALITY ASSURANCE MANAGEMENT The Quality Assurance Management system delivers and assures the defined Quality Product(s), through a well structured process of designing, defining, documenting, training and facilitating all the Quality Delivery resources. The process runs through, but not limited to,
Slide 20: Intellectual Property Management
INTELLECTUAL PROPERTY MANAGEMENT • Supports the management of Intellectual Property • Committed to maintaining and Managing the Confidentiality of the data and transactions • Committed to Functional & Transactional Integrity
Slide 21: Manpower
MANPOWER • An Organization Structure to support the organizational and functional deliverables • Well qualified and experienced Functional Heads • Personnel at different levels of operation recruited with defined Qualifications, inducted into the organization and the functional areas appropriately t
Slide 22: Collaboration - Partnership
COLLABORATION - PARTNERSHIP WE BUILD Customer Focus Speed WE WORK WITH WE DELIVER Transparency Quality Collaboration Integrity & Value Partnership Passion On Time Flexibility
Slide 23: Contact Details
CONTACT DETAILS Contact Person: Mr. B.V.Srinivasa Rao Business Coordination Ph: +919989588202 Email: [email protected] Regd. Office: Operations Office: Suven Nishtaa Pharma Pvt Ltd Suven Nishtaa Pharma Pvt Ltd Serene Chambers, Road No. 5, Avenue 7, Plot Nos. 267 & 268, Phase-II, IP-Pashamylaram,
Slide 24: Thank You
THANK YOU
Suven Nishtaa Pharma Private — Corporate Update (February 2009) on 6ix