Corporate Presentation

Formulation Development

Analytical Development / Services

Contents

• Facility

• Company Brief

• Services offered

• Formulation Development Services

• Analytical Development Services • Analytical Development Services

• Quality Assurance

• Project Management

• Global Presence

• Location

Facility

Company Brief � Fusion Scientific is an independent knowledge based organization having around 18,000

sq. ft. premises located in Navi Mumbai. Our focus is on Pharmaceutical Development

and Analytical Development/Services.

� Fusion has successfully cleared USFDA Audit in 2015 at Previous facility same has been

extended to the new facility at Rabale .extended to the new facility at Rabale .

� The group, established in 2011, is promoted by technocrats having vast experience in

the related fields. We combine Science, Innovation and People to help our clients

address their development related challenges.

� Privately owned Ltd. Company

� Highly qualified personnel

� ISO 9001:2015

� GLP- Conformity

� Local FDA approval

Services Offered

� Formulation Development

� Analytical Method Development

� Analytical Method Validation

� Analytical testing

� Technology Transfer

Formulation Development Capabilities

• I.R. (Immediate Release) Tablets:

� Single layer and multi-layered

� Uncoated, film coated and sugar coated

� Effervescent tablets

• Low Dose

• Modified Release Tablets and Capsules:

� Delayed Release Tablets

� Extended Release Tablets/Capsules

• Semi Solids and Topical Products

• Liquid Dosage Forms such as Syrup, Suspension etc.

• Ophthalmics

Formulation Development – Scope of work

� Literature & Primary Patent Evaluation

� Pre-formulation Studies and Innovator Product Evaluation

� Galenical Formulation Development

� Formulation Optimization

� Process Optimization

� Technology Transfer to CMO Site

� Documentation support in CTD Formats

Project Initiation

Formulation Development

Logistics Analytical Development

Patent evaluation,

literature survey

Application to FDA for test license, DCGI for Import License, NOC

etc.

API Qualification

Strategy development Receipt of API,

reference products,

Product Development Flowchart

Reference product and API

evaluation

reference products, innovator product, working standard,

excipients etc.

Pre-formulation prototype

development

Analytical Method Development

Prototype selection and scale up/process

optimization

Pilot Bio study

Reference product evaluation

Prototype trial/batch analysis

Stability study

Analytical Method Validation

T.T. documentationT.T. documentation

Tech Transfer Support

Formulation Development Equipment List

� Rapid Mixer Granulator

� Fluid Bed Drier

� Cage/ Octagonal Blender

� Compression Machine (Single / Bilayer)

� Roll Compactor

� Auto coater

� Pam Capsule Filling Machine

� Blister Packaging Machine

� Availability of Low Humidity Area

Analytical Services

Pharmaceuticals Industry :

� Analytical Method development and Validation of APIs and finished dosage forms by

HPLC/GC/AAS/ICPMS/IC/GCHead space- MS

� Stability studies as per ICH guidelines

Dissolution profiling� Dissolution profiling

� Pharmaceutical analysis as per IP, USP, EP, BP etc.

� Residual Solvent Validation / Testing

Analytical Lab – Instrumentation List

� HPLC’s with UV, PDA and RI detectors

� GC with Head Space and Liquid Injector

� GC head space-MS

� Thermo ICPMS

� Microwave digestion system � Microwave digestion system

� Ion Chromatography

� UV visible Spectrophotometer

� Atomic Absorption with Hydride Generator

� Stability Chambers with 1000 litres capacity

� Dissolution Apparatus

ICPMS- Inductively coupled plasma mass spectrometry

� January 1, 2018 was the new date of applicability for USP

General Chapters <232>, <233> and <2232> along

with the ICH Q3D guidance.

� To meet these requirement of testing

elemental impurities in the pharmaceutical products elemental impurities in the pharmaceutical products

new analytical protocols using

Inductively coupled plasma mass spectrometry (ICP-MS)

is method of choice.

� With this analytical technique –testing and validation

can be performed in raw material (API and excipients) and Finished dosage form

Milestone-High performance microwave digestion system

� Sample preparation is a fundamental step towards a successful

analysis and its importance can not be underestimated.

� The ETHOS UP is specifically designed;

� for high pressure, closed vessel acid digestion- thisfor high pressure, closed vessel acid digestion- this

Approach helps in retention of volatile elements.

� High safety

� Fast digestion

� Low quantity of acid required ensuring accurate results

� Multiple sample analysis without cross contamination

Ion Chromatography -Dionex

� The Thermo Scientific™

Dionex™ ICS-5000+ System

Ion chromatography is a well-established

technique used for analyzing anions andtechnique used for analyzing anions and

cations in pharmaceutical, environmental,

food and many other samples.

GC HS –MS- Gas chromatography Head space mass

spectroscopy

� Recently several Sartan group of drug products intended for Angiotensin II receptor

block (ARB) were recalled based on the observations for the presence of following

Nitrosamines in finished goods as potentially carcinogenic impurities as a contaminant.

�N-Nitrosodimethylamine (NDMA)

� N-Nitrosodiethylamine (NDEA)

� N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)

� Nitrosodibutylamme (NDBA)

� N Nitroso di isopropylamine (NDIPA)

� N-Nitroso Pyrrolidine

� N Nitroso ethyl iso propylamine (NEIPA)

� N-Nitrosomorpholine

� N-Nitroso di propylamine (NDPA)

� N-Nitroso Piperidine

� Fusion is leading Analytical testing laboratory and can utilize established USFDA issued

methods for above listed impurities and also ready to support for development and

validation of above listed impurities in drug substance and drug products.

Quality Assurance

� Independent Quality Assurance department.

� Responsible for driving the Quality Management systems.

� Ensuring the GDP and GLP practices are implemented and followed.

� Monitoring the calibration activities as per Calibration schedule.

� Ensuring Periodic SOP trainings .

� Periodic internal audits are conducted and driven by Quality Assurance.

Project Management

Project management team with experience in various aspects of pharmaceutical field are

responsible for the following activities,

� Single point of contact for communication with Client

� Co-ordinate the on going project related daily activities

� Provide biweekly project updates to Client by email/telecons

� Ensure to achieve the committed project timelines

Global Presence

CANADA

USA

UK

GREECE

TURKEY

RUSSIA

CHINAGCC

Currently working on Formulation Development Projects for the above markets on

AUSTRALIA

GCC

South Africa

FUSION SCIENTIFIC LABORATORIES PVT. LTD.

Plot No. R-656 -TTC Industrial area,

MIDC Rabale,

Navi Mumbai – 400701

Maharashtra, India.

Email: info@fstin.com

Website: : www.fstin.com

� ~25 km from Mumbai International Airport

Contact Person Contact details

Mr. Manohar Kotwani Email id: manohar.kotwani@fstin.com

Mobile No.: +91 9819075071

Mr. Deepak Patel Email id: deepak.patel@fstin.com

Mobile No.: +91 9892086409

Ms. Rashmi Prasade Email id: rashmi.prasade@fstin.com

Mobile No.: +91 9820740366