SANA Pharma is a fast growing Research Company with a … pharma... · differences between diverse...
Transcript of SANA Pharma is a fast growing Research Company with a … pharma... · differences between diverse...
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SANA Pharma is a fast growing Research Company with a
broad spectrum of pharmaceutical services managed at
highest standard level.
SANA Pharma has been recognized as one of the fastest
growing companies in the region in 2011 & 2012 (All world
network and Harvard business school classification).
Independent R&D with ISO 17025 certified laboratories,
provide Tech transfer projects and analytical services.
Market driven research company focusing on market needs.
Integrated pharmaceutical engineering services.
SANA PHARMA: MARKET DRIVEN RESEARCH
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• SANA Vision
To be the outsourcing partner of choice to generic pharmaceutical companies in the region
and world wide.
• SANA Mission
SANA Pharma objectives are to increase the pharmaceutical companies' sales and profits
through development/licensing pharmaceutical products, analytical services, technologies
to their pipelines.
SANA Pharma is working on licensing an advanced and niche projects to pharmaceutical
companies in order to maximize their profits and reduce their competition.
SANA Pharma, and through its qualified laboratories, and being work under international
GLP standards (ISO 17025, 2005) provides various technical services at an affordable cost.
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Established by technocrats and expertise from Pharma industry in 2007.
Currently has business projects in more than 24 countries including Europe.
Turnover in 2015: $3.5 Million.
Efficient network in MENA region and EU.
Activities/History
Activities Year
Pharmaceutical Service activities:
Product development, Contract analysis, Regulatory consultation 2007
Service activities linked with longterm supply agreements or royalty based or
profit sharing (niche products) 2010
Started market authorization business, and marketing medicated cosmetics,
CNS products in Jordan and MENA region (based on contract manufacturing) 2011
Started the first manufacturing site for medicated cosmetics in Amman-Jordan 2012
Integration of product development, API business and technology transfer 2013
Developed new processes for Sofosbuvir API and established Technovir
company to handle the business of HCV products in Egypt and the region. 2014
Entering new markets in EU and Asia. 2016
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Advisory board
Microbiology
supervisor
Analysis S.H
/Technical
Manager
Quality
Manager
Microbial
testing:
pharmaceutical,
cosmetic
product and
water
Analysis
supervisor
Chemical
Analyst
Regulatory
supervisor
Regulatory
Officer
R&D Advisor
Pre-formulation
S.H
Formulation
S.H
QA officer
physiochemical
QA officer
Microbiology
Analytical Services
,analytical methods
,development and
validation stability
Compliance,
documentation
control ,internal
audits
SANA PHARMA: MARKET DRIVEN RESEARCH
General
Manager
Regulatory
Manager Development
Manager
Quality Manager Business
Development
Manager
Financial Manager
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Site map/technical departments
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As key success factor
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Department # of employee
QC 14 (8 females)
QA 4 (2 females)
Microlab 4 (3 females)
Development and technology transfer 8 (3 females)
Regulatory 6 (6 females)
HR/Finance 4 (2 females)
Technical director Mohammad Alfar
GM Samer Najjar
Business development 2
Sales & Marketing 10 (4 females)
Quality director Mohammad Al Far
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M.Sc. Pharmaceutical technology, with focused research on transdermal
drug delivery system and drug release from sustained release matrices.
20 years of experience in pharmaceutical research. 7 Years of them as R&D
manager at Joswe medical and responsible for development their pipeline.
Extensive knowledge and experience of analytical methods development,
validation, Pre-formulation, stability testing, and scaling up of products.
Extensive knowledge and experience of regulatory filing including CTD
dossiers preparation and response to regulatory inquiries.
Good knowledge of IPR issues related to formulation and registration
processes.
Extensive knowledge of pharmacokinetics related to drug development and
conduction of bioequivalence studies, with solid experience in monitoring
and auditing of bioequivalence studies and CRO's.
Good knowledge and experience in cGMP and site inspection.
Member of JFDA committees for quality control and site
inspection/approval
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Former R&D director at Pharma international.
26 years of experience in pharmaceutical research at DAD, Hayat Pharma
and PIC. Extensive knowledge and experience of development of different
dosage forms including sustained release product and drug combination
and more than 120 product successfully developed with BE successful rate
> 95%.
Successful product registration in regulated markets including EU.
Good knowledge of IPR issues related to formulation and registration
processes.
Extensive knowledge of pharmacokinetics related to drug development and
conduction of bioequivalence studies.
Good knowledge and experience in cGMP and site inspection.
Member of JFDA committees for site approvals and a JFDA quality
inspector.
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B.Sc. (Pharm.), M. Phil., JPA
Intensive marketing experience at regional level (MENA), Near East, Indian
subcontinent, Far East and Europe
Uncompromising ethics and transparent communications underpin
business-focused value proposition that facilitate competitiveness via high
standard service.
A result oriented professional with leadership skills, skilled in bridging
differences between diverse agenda and directing them to a common goal,
in unifying team efforts and optimizing its dynamics, and harnessing
strategic and operational drivers to achieve the desired goals.
Eager to execute a stretched role that involves planning, adding for
growth, subtracting for profit, improvement of business processes and
broad understanding of competitiveness that will consequently alter the
status quo of the business.
Acknowledged for well defined understanding of the generic
pharmaceutical business and capacity to identify and align emerging
markets needs and emerging technologies effects with products and
services. with emphasis on Pharmaceutical biotechnology products,
Oncology and potent drugs.
God bless his sole
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B.Sc. pharmacy
10 years experience in registration and regulatory departments at
Joswe medical, Tabuk Pharma and Sana Pharma.
Expert in CTD files preparation (Common technical documents) and EU
regulations.
Excellent experience in registration requirement in MENA region.
Working on registration at regulated markets.
Excellent experience and knowledge of documentation and archiving.
Expert in Pharmacovigilance and post marketing surveillance.
Excellent experience in preparing PSUR.
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BSc. Applied Chemistry
20 years of experience in pharmaceutical analysis.
Quality inspector for JAS.
Expert of GLP and ISO 17025 quality system
Working under regulated analytical environment.
Expert of analytical method development and analytical method
transfer.
Validation and stability studies.
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ISO 17025
Certified Laboratories
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Testing of finished product.
Testing of active ingredient including impurity profile.
Stability studies.
Comparative dissolution studies of solid dosage forms
In vitro release from semisolid products.
Analytical method development and validation.
Microbial testing of material and finished products of
pharmaceutical and cosmetic products.
Pharmacodynamic studies using comparative enzymatic
assay.
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SANA PHARMA: Market Driver Research
LABs
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• Dissolution Apparatus for solid
Dosage form
• Franz Diffusion cell for semisolid
dosage form
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• Provide method development
experimental design, progress report,
method validation protocol and report
and method monograph.
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• With a network of ICH stability
storage facilities, we offer an
extensive capacity and a range
of conditions including climatic
walk in chambers, cabinets and
refrigerated storage which are
fully controlled and monitored.
SANA PHARMA: MARKET DRIVEN RESEARSH
40 C 75%RH
Stability Chambers 30 C 65 %RH 40 C 75 %RH
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• Qualified to provide the following tests:
• Total microbial count
• Microbial contamination
• Bioassay
• Preservative effectiveness
• LAL test
• Sanitizer Efficacy test
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SANA PHARMA: MARKET DRIVEN RESEARSH
Micro lab
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Pilot area
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SANA PHARMA: THE TECHNICAL PARTNER OF CHOICE
JFDA (Jordan food and drug administration)
Sana laboratories were inspected and approved by JFDA for drug development, stability
testing, contract analysis and technology transfer. SANA NOW IS RECOGNIZED AS
REFERENCE LABORATORY
ISO 17025
Sana laboratories were inspected by Jordan Accreditation System (JAS) and approved as
reference laboratories for contract analysis (ISO/IEC 17025).
Sana pharma laboratories have been inspected by European CRO in Austria, Labatec
(Switzerland) and have been approved for conducting various analytical testing for finished
products.
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Publications
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• Sana pharma involved in many research projects in different areas. The following were published in an international journals:
• Solubility of Diclofenac sodium, effect off additive. A comparative study with Diclofenac Diethylamine, Drug development & industrial pharmacy, 2000.
• The use of Drug excipient in designing and evaluation of TDDS, under publication.
• Spectroscopic and HPLC methods for determination of Alendronate in tablets and urine, Talanta 64(2004) 695-702.
• Olanzapine Inhibits Glycogen Synthase Kinase-3β: An Investigation by Docking Simulation and Experimental Validation, European Journal of pharmacology, under publication.
• Sustained release suspension of an antiepileptic for pediatric applications", patent under filing in cooperation with a group of researchers, faculty of pharmacy, UJ.
• Modulation of Buspirone HCl release from hypromellose matrices using chitosan succinate: Implication for pH-independent release. European journal of pharmaceutics and biopharmaceutics (2008).
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• Novel HPLC method for determination of Sitosterols in herbal products, (under
publication).
• Determination of Primeverin and Primulaverin in cough syrup containing Primula root
extract, (under publication).
• SANA PHARMA HAS DEVELOPED NOVEL PROCESS FOR TOLPERISONE TABLET (MUSCLE
RELAXANT) AND IN THE PROCESS OF PATENT FILING.
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Exposure to regulated Market
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• CTD filing.
• Response to deficiency letters.
• Translation of leaflets, patents,…
• Expert reports: clinical and non clinical.
• QOS
• PSUR
• Readability of the labeling and package leaflets.
• PK and biowaiver reports
• Re-registration file review and update.
• Stability study review and justifications.
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Turnkey Projects
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Tracking records & the added value
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Through collaborative integration with international
engineering companies and manufacturers of
machineries, utilities and cleanrooms.
Sana pharma provides:
Turnkey projects
Machineries and utilities
Cleanrooms.
Validation master plan and full documentation system
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• Development of oncology pipeline.
• Development of HCV pipeline.
• Development of CNS pipeline.
• Injectable product pipeline.
• Development of novel combination and super generic products.
• Qualification of JFDA laboratories according to ISO 17025 (Project supported by EU union).
• Development, manufacturing and selling niche medicated cosmetic products
• in Jordan and MENA.
• Development of OTC products for a Swiss company.
• Novel manufacturing process development for challenging drugs.
• Successful technology transfer projects in MENA region and EU.
• Successful process development of two API’s: Fingolimod & Sofosbuvir integrated with finished product dossier development.
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SANA PHARMA: MARKET DRIVEN RESEARCH
Strategic
customer
The added value
Hikma First generic pipeline of potential products including
Quetiapine XR, Tacrolimus ointment, Sitagliptin, Orlistat
Elkendi (Algeria) This company started at the same time with Sana
pharma and sales increased exceeding 140 Million in
2015. Sana pharma is responsible for 30-35% of Elkendi
pipeline
Pharma
international (PIC)
A pipeline product including MEBO, orlistat, sofosbuvir,
Fingolimod, and CNS pipeline
Labatec
Switzerland
Tolperisone F/C tablet, with novel manufacturing
process, vitamin D3 high dose,
Saiph (Tunisia) CV, CNS pipelines development
Biopharm (Algeria) CV, CNS pipelines development
Razes, Algeria Injectable pipeline
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Sana Pharma technology transfer projects added 150 Millions sales in
2015 for customers received Sana dossiers of different therapeutic
classes.
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• Sana Pharma has developed, registered, manufactured and
marketed a pipeline of niche medicated
cosmetics/cosmeceuticals in Jordan and MENA region.
• The main category of Sana products cover Scars,
dermatological product, muscles and joints care products,
male & female lubricants.
• CE mark obtained.
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SANA PHARMA: Market Driver Research