sana pharma is a fast growing research company with a sana...

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

• 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.


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


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


General

Manager

Regulatory

Manager Development

Manager

Quality Manager Business

Development

Manager

Financial Manager

Site map/technical departments


SANA PHARMA: MARKET DRIVEN RESEARSH

As key success factor

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


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

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.

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

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.

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.

ISO 17025

Certified Laboratories


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.


SANA PHARMA: Market Driver Research

LABs

• Dissolution Apparatus for solid

Dosage form

• Franz Diffusion cell for semisolid

dosage form


• Provide method development

experimental design, progress report,

method validation protocol and report

and method monograph.


• 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.


40 C 75%RH

Stability Chambers 30 C 65 %RH 40 C 75 %RH

• Qualified to provide the following tests:

• Total microbial count

• Microbial contamination

• Bioassay

• Preservative effectiveness

• LAL test

• Sanitizer Efficacy test



Micro lab

Pilot area


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.

Publications


• 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).


• 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.


Exposure to regulated Market


• 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.


Turnkey Projects


Tracking records & the added value


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


• 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.



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

Sana Pharma technology transfer projects added 150 Millions sales in

2015 for customers received Sana dossiers of different therapeutic

classes.


• 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.


sana pharma is a fast growing research company with a sana...

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