Quality a Passion - Value a Commitment SUVEN LIFE SCIENCES … · Quality a Passion - Value a...
Transcript of Quality a Passion - Value a Commitment SUVEN LIFE SCIENCES … · Quality a Passion - Value a...
Quality a Passion - Value a Commitment
The Complete Pharmaceutical Services OrganizationHyderabad, India
www.suven.com Tel: +91 40 2354 1142 Fax: +91 40 2354 1152
SUVEN LIFE SCIENCES LIMITED
FORMULATIONS DEVELOPMENT CENTRE (FDC)
PresentationGeneral Capabilities
Chem lib /comb chem hits
Leadidentification /characterization
LeadOptimization
PreClinical
ClinicalTrials
ProcessResearch
CustomSynthesis
FormulationDevelopment,Analytical &RegulatoryServices
ClinicalSuppliesManufacturing& Packaging
Drug Discovery Drug Product Delivery
SUVEN’S BUSINESS MODEL
Contract Pharma ServicesDrug Discovery & Development Support Services
(DDDSS)
Services offered by FDC
Quality a Passion - Value a Commitment
• Formulation Development Laboratories
• Dedicated and Customized Laboratories for Formulation Development
• Technology Laboratories for New Drug Delivery Systems Development
• Process Development Laboratories
• Packaging Development and Testing Laboratories
• cGMP Scale-up, Manufacturing and Packing of Exhibit and Clinical Supply batches
• Analytical Method Development & Validation Laboratories
• Microbiology Testing Laboratory
• Stability Chambers
• Warehouse
110,000+ sq.ft of world-class infrastructure comprising:
FDC CAPABILITIES
Quality a Passion - Value a Commitment
• Product Development
• Generics Formulations• Novel Drug Delivery Systems• NCE Formulations
• Scale UP and Manufacturing• Analytical Services• Regulatory Management
Quality a Passion - Value a Commitment
PHARMACEUTICAL PRODUCT SERVICES
PHARMACEUTICALDEVELOPMENT
Quality a Passion - Value a Commitment
PHARMACEUTICAL DEVELOPMENT-INFRASTRUCTURE
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
Quality a Passion - Value a Commitment
PHARMACEUTICAL DEVELOPMENT-INFRASTRUCTURE
R&D LAB AREAS PROCESS DEVELOPMENT AREAS
PRODUCT DEVELOPMENT LABS
Quality a Passion - Value a Commitment
PHARMACEUTICAL DEVELOPMENT-INFRASTRUCTURE
Laboratory to Pilot Plant – Equipments of Similar Design and Work Mechanism
Rapid Mixer Granulator (RMG)
Equipment with flexibility of using 3, 5 and 10L capacity replaceable bowls for batch sizesranging from 0.5 kg to 3 kg
Blenders(Double Cone & Octagonal)
Blenders with flexibility of using5 and 20 L capacity for handling
batch sizes ranging from 0.5 kg to 7 kg
Quality a Passion - Value a Commitment
PHARMACEUTICAL DEVELOPMENT-INFRASTRUCTURE
Automated Tablet Press
Instrumented, 10 station Rotary Tabletcompression machine with pre-compressionfacility
Automated Capsule Filling Machine
Automated, Mini capsule filling with addedcapability to fill pellets, pellets and powders,
tablets in capsule, tablet and powder, pellets andtablets in capsule etc.
Quality a Passion - Value a Commitment
PHARMACEUTICAL DEVELOPMENT-INFRASTRUCTURE
Fluid Bed Processor (FBC)
PLC based equipment for handling particle/pelletcoating and Top spray granulations for batch sizes 0.5 -2 kg
Fluid Bed Dryer
PLC based equipment for handling both Granuledrying and Top spray granulation for batch sizes
up to 2 kg
Quality a Passion - Value a Commitment
PHARMACEUTICAL DEVELOPMENT-INFRASTRUCTURE
Automated Coating Pan
PLC based equipment with replaceable pans forhandling different batch capacities ranging from 0.5 kg
to 5 kg.
Blister Packaging Machine
Laboratory scale Blister packing machine forboth Alu/Alu and PVC blisters
Quality a Passion - Value a Commitment
PHARMACEUTICAL DEVELOPMENT-INFRASTRUCTURE
Lyophilizer
Bench top Lyophiliser with programming inboth manual and auto mode
Spray Dryer
Table-top Spray dryer suitable for handlingsmall scale batches for both aqueous and
non-aqueous applications
Quality a Passion - Value a Commitment
PHARMACEUTICAL DEVELOPMENT-INFRASTRUCTURE
Ampoules, Vials and Pre-filledSyringes filling machine
Quality a Passion - Value a Commitment
PHARMACEUTCAL DEVELOPMENT-SERVICES
Generic Product Development
Liquid Orals• Solutions• Suspensions• Emulsions Sterile Products
Injectables
Lyophilized FormulationsOphthalmic / Aural Preparations
Topical Preparations• Ointments• Creams• Gels
Quality a Passion - Value a Commitment
PHARMACEUTICAL DEVELOPMENT-SERVICES
Product Development – Special Capabilities
Bilayered Tablets Dry Coated Tablets
Pellets,MUPS Tablet in Capsule
Tablet & Powder in Capsule Tablet & Pellets in Capsule
Extended Release Formulations
Cytotoxic Products *
Steroid / Hormonal Products * Highly Potent Drug Products *
(* Product Development Only)
PHARMACEUTICAL DEVELOPMENT-SERVICESQuality a Passion - Value a Commitment
PHARMACEUTICAL DEVELOPMENT-SERVICES
NCEs Formulation Development
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Early Formulation Development
Clinical Product Development
Scale-up and Manufacturing of IND batches
Manufacturing and Packaging of Clinical Supplies
( Phase I-III)
Placebo Manufacture
Comparator Product Modifications
Multi-Product Packing
Kit Assembly
Quality a Passion - Value a Commitment
NOVEL DRUG DELIVERY SYSTEMS
Quality a Passion - Value a Commitment
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Sustained Release/ Extended Release/ Controlled Release/
Delayed Release Formulations
Taste Masking
Topical Drug Delivery
NOVEL DRUG DELIVERY SYSTEMS
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Topical Patch Delivery Systems
• Immediate release/ Long Acting
Ointments and lotions
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Lyophilisation Technology
Spray Drying Technology
Quality a Passion - Value a Commitment
SCALE - UP & MANUFACTURING
Quality a Passion - Value a Commitment
cGMP Manufacturing Facility for Manufacture of Solid orals
SCALE - UP AND MANUFACTURING
Capabilities for the manufacture of
Tablets
Capsules
Pellets
Granules
Powders
Packing (bulk packing HDPE/PP/Other Containers)
Blister Packing (Thermo forming and cold forming)
Quality a Passion - Value a Commitment
SCALE - UP AND MANUFACTURING
To manufacture solid oral dosage forms
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State-of-the-art facility
Meets any Global Standards
Clean Rooms confirming to Class 10,000, under static conditions
Well designed contamination containment and
controlled systems
cGMP compliant systems, procedures and practices
PLC controlled and automated equipments
Flexible batch sizes
Flexibility in equipment selection
Quality a Passion - Value a Commitment
ANALYTICAL SERVICES
Quality a Passion - Value a Commitment
ANALYTICAL SERVICES
Instrumentation Laboratories – 4 Nos
Dissolution Testing Laboratory
Chemical Testing Laboratory
Solution Preparation Laboratories – 3 Nos
Microbiological Testing Laboratory
Chemical Labs Instrumentation Labs
Quality a Passion - Value a Commitment
ANALYTICAL SERVICES
Dissolution Testing Labs Instrumentation Labs
Stability Chambers
Quality a Passion - Value a Commitment
• Analytical Method Development
• Analytical Method Validation
• Impurity Profiling
• Microbiological Testing
ANALYTICAL SERVICES
• Stability Management (Pre & Post Marketing)
Quality a Passion - Value a Commitment
• State of the art well designed and equipped labs
• Modern Analytical Instruments compliant to 21 CFR part 11HPLCs
ANALYTICAL SERVICES
Analytical Method Development, Validation & Impurity Profiling
GC-HS & LS DSC
Particle Size Analyzers FTIR and others
Quality a Passion - Value a Commitment
ANALYTICAL SERVICES
Microbial testing
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Microbial Limit Tests
Preservative Efficacy
Sterility
Endo toxins
Quality a Passion - Value a Commitment
STABILITY MANAGEMENT
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Meets ICH Guidelines for all temperature zones
10 walk-in Stability Chambers of 230,000 liters
Automated Multi Point Temperature and RH recording
Well defined samples inventory and stability
management systems
21 CFR Part 11 compliant
Photo stability testing with intensity, temperature and RH
control
Quality a Passion - Value a Commitment
REGULATORY & QUALITYASSURANCE MANAGEMENT
Quality a Passion - Value a Commitment
REGULATORY MANAGEMENT
Offers entire back-end support
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Dossier Compilation
Preparation of Regulatory Responses
Post Approval Regulatory Changes
Compliance Audits
Submission of Annual Reports
Quality a Passion - Value a Commitment
Suven Life Sciences is committed to deliver quality services to all customers at all
the times.
QUALITY POLICYQuality a Passion - Value a Commitment
QUALITY ASSURANCE MANAGEMENT
• QA management comprises
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Development Assurance
Analytical Assurance
Manufacturing Assurance
Engineering Assurance
Training
Internal Quality Audits and Reviews
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QA management to ensure systems design, training & compliance
Systems to identify failures and incidents
Document issue and control
Change control management
Internal Audits to ascertain compliance to systems and takecorrective and preventive measures.
Document Archival and control samples management
Stability Management
Quality a Passion - Value a Commitment
INTELLECTUAL PROPERTY MANAGEMENT
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Supports the management of Intellectual Property
Committed to maintaining and Managing the
confidentiality of the data and transactions
Committed to Functional & Transactional Integrity
and client data to unauthorized personnel
Confidentiality Agreement between various Stake holders
IT Enabled systems to firewall and track confidential and IP
related information
Quality a Passion - Value a Commitment
S.NO TypesofPatentApplications
PatentapplicationsfiledbySuven FDC
1. FormulationPatentApplications
10
Patents Applied By Suven NishtaaQuality a Passion - Value a Commitment
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MANPOWER
An Organization Structure to support theorganizational and functional deliverables.
Well qualified and experienced personnel.
Personnel at different levels of operation recruitedwith defined Qualifications, inducted into theorganization and the functional areasappropriately trained and Qualified.
Quality a Passion - Value a Commitment
S.No Department Strength
1. ResearchandDevelopment 23
2. Analytical 24
3. QualityAssurance 11
4. Production 3
5. IPM/RegulatoryAffairs 1
6. Administration&Others 12
Quality a Passion - Value a CommitmentMANPOWER-DISTRIBUTION
“To become a preferred global pharmaceutical product services providerdelivering value and quality to the customers through collaborations and partnerships”.
VISIONQuality a Passion - Value a Commitment
Custom
erFocus
Speed
Flex
ibili
ty
Collaboration&
PartnershipIntegrity
Passion
Value
On Time
We are committed to deliver what we promise.
COLLABORATION – PARTNERSHIP
WE BUILD
Quality a Passion - Value a Commitment
Integrity
Passion
Collaboration &
Patnership
Custom
erFocus
Speed
WE DELIVER
Quality
WE WORK WITH
Transparency
Value
On Time
Flex
ibili
ty
Regd. Office:
Suven Life Sciences LimitedSerene Chambers, Road No. 5,Avenue 7,Banjara Hills,Hyderabad, INDIA – 500 034www.suven.com
Operations Office:
Suven Life Sciences LimitedPlot Nos. 267 & 268,Phase-II, IP-Pashamylaram,Patancheru (Mandal), Medak (Dist),AP, INDIA – 502 307Tel.: +91-8455-326021, 6022
CONTACT DETAILS
N . Kamalakara RaoBusiness Planning & Co-ordinationPh: +919989588205Email: [email protected]
M . Mohan RaoVice President Business Development Ph: +919392483023Email: [email protected]
Contact Persons
Quality a Passion - Value a Commitment