Quality a Passion - Value a Commitment SUVEN LIFE SCIENCES … · Quality a Passion - Value a Commitment. The Complete Pharmaceutical Services Organization. Hyderabad, India. : +91

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


• 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


• Product Development

• Generics Formulations• Novel Drug Delivery Systems• NCE Formulations

• Scale UP and Manufacturing• Analytical Services• Regulatory Management


PHARMACEUTICAL PRODUCT SERVICES

PHARMACEUTICALDEVELOPMENT


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



R&D LAB AREAS PROCESS DEVELOPMENT AREAS

PRODUCT DEVELOPMENT LABS



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



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.



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



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



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



Ampoules, Vials and Pre-filledSyringes filling machine


PHARMACEUTCAL DEVELOPMENT-SERVICES

Generic Product Development

Liquid Orals• Solutions• Suspensions• Emulsions Sterile Products

Injectables

Lyophilized FormulationsOphthalmic / Aural Preparations

Topical Preparations• Ointments• Creams• Gels


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


NOVEL DRUG DELIVERY SYSTEMS


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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


SCALE - UP & MANUFACTURING


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)


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


ANALYTICAL SERVICES


ANALYTICAL SERVICES

Instrumentation Laboratories – 4 Nos

Dissolution Testing Laboratory

Chemical Testing Laboratory

Solution Preparation Laboratories – 3 Nos

Microbiological Testing Laboratory

Chemical Labs Instrumentation Labs


ANALYTICAL SERVICES

Dissolution Testing Labs Instrumentation Labs

Stability Chambers


• Analytical Method Development

• Analytical Method Validation

• Impurity Profiling

• Microbiological Testing

ANALYTICAL SERVICES

• Stability Management (Pre & Post Marketing)


• 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


ANALYTICAL SERVICES

Microbial testing

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Microbial Limit Tests

Preservative Efficacy

Sterility

Endo toxins


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


REGULATORY & QUALITYASSURANCE MANAGEMENT


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


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


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


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.


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


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


Documents

Quality a Passion - Value a Commitment SUVEN LIFE SCIENCES … · Quality a Passion - Value a Commitment. The Complete Pharmaceutical Services Organization. Hyderabad, India. : +91