efarmes (spain) company presentation
DESCRIPTION
Introduction to leading generic dossier developer and manufactureTRANSCRIPT
EFARMES S.A.U.
Capabilities Activities
The CompanyKey FactsOrganizational ChartBusiness Purpose
Efarmes Development Lab.Lacer Manufacturing Site
CollaborationsGeneric Dossier Develop Custom ManufacturingGeneric Supply
VIEW OUR PRODUCTS: genericlicensing.com/efarmes – DIRECT CONTACT
Our Mi s s i on
EFARMES S.A.U.
Activities
Capabilities
The CompanyKey FactsOrganizational ChartBusiness Purpose
CollaborationsGeneric Dossier DevelopCustom ManufacturingGeneric Supply
Efarmes Develop. Lab.Lacer Manufacturing Site
VIEW OUR PRODUCTS: genericlicensing.com/efarmes – DIRECT CONTACT
/HI STORY MI LESTONES
1987 . . . . .Lac e r S A pur c has e s Ef arme s S A U
1995 Ef arme s be c ome s t he ge ne r i c bus i ne s s uni t of Lac e r 1 by l aunc hi ng i t s s t ge ne r i c pr oduc t i n Spai n
3 . Qual i x Pharmac e ut i c al s i s f ounded by Ef arme s A whol l y owned s ubs i di ar y and marke t i ng arm of Ef arme s
i n Spai n
2004 Trans f e r of al l manuf ac t ur i ng ac t i vi t i e s t o’ Lac e r s br and new s i t e
5 Qual i x s e l l s i t s ge ne r i c pi pe l i ne t o Ranbaxy
6 Ef arme s r e de f i ne s i t s ge ne r i c ac t i vi t i e s unde r a new s t r at e gy
7 1 Ef arme s l aunc he s i t s s t pr oduc t s out s i de t he EU
8 - Fi r s t MA appr oval of c o de ve l opment i n t he EU
9 Fi r s t appr oval of Marke t i ng Aut hor i z at i ons t hr oughDCP
The Company
EFARMES S.A.U.
Activities
Capabilities
The CompanyKey FactsOrganizational ChartBusiness Purpose
CollaborationsGeneric Dossier DevelopCustom ManufacturingGeneric Supply
Efarmes Develop. Lab.Lacer Manufacturing Site
VIEW OUR PRODUCTS: genericlicensing.com/efarmes – DIRECT CONTACT
PROFI LE
The Company
EFARMES S.A.U.
Activities
Capabilities
The CompanyKey FactsOrganizational ChartBusiness Purpose
CollaborationsGeneric Dossier DevelopCustom ManufacturingGeneric Supply
Efarmes Develop. Lab.Lacer Manufacturing Site
VIEW OUR PRODUCTS: genericlicensing.com/efarmes – DIRECT CONTACT
EFARMES S.A.U.
Activities
Capabilities
The CompanyKey FactsOrganizational ChartBusiness Purpose
CollaborationsGeneric Dossier DevelopCustom ManufacturingGeneric Supply
Efarmes Develop. Lab.Lacer Manufacturing Site
Key Fac t s
I nc r e as e of l i c e ns i ng ac t i vi t y t hr ough par t ne r al l i anc e s wi t h t op pharmac e ut i c al
c ompani e s f oc us i ng on i nt e r nat i onal gr owt h 2006s i nc e
- Co de ve l opment s and t hi r d par t y ( ) 25% de ve l opment s and s uppl y have r e ac he d
80% of our ac t i vi t y and of our gr owt h i n2010
• New bus i ne s s oppor t uni t i e s f or “ni c he ( ) marke t s ” pr oduc t s avai l abl e wi t h MA
• Di ve r s i f i c at i on of ge ne r i c de ve l opment ( , por t f ol i o i n new marke t s e gment s OTC
)ge ne r i c s pl us
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DIRECTOREFARMES
ASSI STANT
BUSINESS DEV.
Ef arme s Or gani z at i onal Char t
CONTROLLI NGREGULATORYAFFAI RS
PHARMACEUTI CAL
R&D
REGULATORY AFFAIRS
GALENI CALDEVELOPMEN
T
PHARMACEUTICAL R&D
CONTROLLING
GALENICAL DEVELOPMENT
ASSISTANT
ANALYTICALDEVELOPMENT
EFARMES S.A.U.
Activities
Capabilities
The CompanyKey FactsOrganizational ChartBusiness Purpose
CollaborationsGeneric Dossier DevelopCustom ManufacturingGeneric Supply
Efarmes Develop. Lab.Lacer Manufacturing Site
VIEW OUR PRODUCTS: genericlicensing.com/efarmes – DIRECT CONTACT
:EFARMES of f e r s i t s c us t ome r s
Dos s i e r s i n CTD f ormat of ge ne r i c f i ni s he d dos age f orms and f ul l r e gul at or y s e r vi c e
’ unt i l mar ke t i ng aut hor i z at i on of c os t ume r s.pr oduc t s
, -Suppl y of l i c e ns e d s ol i d l i qui d and s emi s ol i d pharmac e ut i c al pr oduc t s unde r
’ .c us t ome r s br and
( ) .Cont r ac t manuf ac t ur e s e r vi c e by LACER
.Added val ue t hr ough i nnovat i ve f ormul at i on
Bus i ne s s Pur pos e
EFARMES S.A.U.
Activities
Capabilities
The CompanyKey FactsOrganizational ChartBusiness Purpose
CollaborationsGeneric Dossier DevelopCustom ManufacturingGeneric Supply
Efarmes Develop. Lab.Lacer Manufacturing Site
VIEW OUR PRODUCTS: genericlicensing.com/efarmes – DIRECT CONTACT
Ef arme s De ve l opmentLabor at or i e s
Mai n f e at ur e s600 m2 of l abor at or y s pac e cGMP pi l ot s c al e pl ant
Formul at i on ( , , )Sol i ds c aps ul e s t abl e t s c oat e d t abl e t s ( , )Oral l i qui ds s ol ut i ons s us pe ns i ons - ( , , , )Semi s ol i ds oi nt ment s ge l s c r e ams pas t e s Pharmac e ut i c al de ve l opment i n ac c or danc e wi t h t he I CH : - ( - , Convent i onal e qui pment mi xe r s gr anul at or s V t wi n bl e nde r s
) , Col l e t t e dr ye r s ( , ) , f l ui d be d ove n and Mi l l s c aps ul e and t abl e t machi ne r y
t abl e t c oat i ng ( - - ) , f i l m c oat i ng and s ugar c oat i ng pac kagi ng f ac i l i t i e s
i nc l udi ng bl i s t e r i ng machi ne r y
Anal yt i c al De ve l opment HPLC equi pment St abi l i t y Chambe r s Me t hod de ve l opment & mi c r obi ol ogi c al t e s t i ng val i dat i on St abi l i t y t e s t i ng i n ac c or danc e wi t h t he I CH : , - , , -I ns t r ument at i on i nc l ude s HPLC HPLC MS GC GC MS e qui pment ( . 1 2) . Sol ut i on e qui pment App & Al l ge ne r al c hemi s t r y
, t e c hni que s s t abi l i t y Chambe r s
EFARMES S.A.U.
Activities
Capabilities
The CompanyKey FactsOrganizational ChartBusiness Purpose
CollaborationsGeneric Dossier DevelopCustom ManufacturingGeneric Supply
Efarmes Develop. Lab.Lacer Manufacturing Site
VIEW OUR PRODUCTS: genericlicensing.com/efarmes – DIRECT CONTACT
Lac e r Gr oup Manuf ac t ur i ng Si t e
15, 000 m2 - - - s t at e of t he ar t manuf ac t ur i ng s i t e
Loc at e d i n Bar c e l ona pr ovi nc e
, - Spe c i al i z e d i n l i qui ds s emi s ol i ds and s ol i ds
Ful l y cGMP manuf ac t ur i ng s i t e f or c omme r c i al and pi l ot bat c he s
EFARMES S.A.U.
Activities
Capabilities
The CompanyKey FactsOrganizational ChartBusiness Purpose
CollaborationsGeneric Dossier DevelopCustom ManufacturingGeneric Supply
Efarmes Develop. Lab.Lacer Manufacturing Site
VIEW OUR PRODUCTS: genericlicensing.com/efarmes – DIRECT CONTACT
: De f i ni t i on of i nt e r e s t l i c e ns e of e xi s t i ng, -de ve l opment c us t om de ve l opment or c o
de ve l opment
De f i ni t i on of t he l i c e ns i ng s t r at e gy
Di s c us s i on of t he de ve l opment pl an and c oope r at i on c ondi t i ons
Si gni ng of /l i c e ns e de ve l opment and s uppl yagr e ement
: - / I f appl i c abl e f ol l ow up of de ve l opment and or r e gi s t r at i on pr oc e s s unt i l c onc l ude d
Trans f e r of t he marke t i ng aut hor i z at i on t o, c l i e nt l aunc h and s uppl y of f i ni s he d pr oduc t
EFARMES S.A.U.
Activities
Capabilities
The CompanyKey FactsOrganizational ChartBusiness Purpose
CollaborationsGeneric Dossier DevelopCustom ManufacturingGeneric Supply
Efarmes Develop. Lab.Lacer Manufacturing Site
VIEW OUR PRODUCTS: genericlicensing.com/efarmes – DIRECT CONTACT
De f i ni ng a pat e nt & c omme r c i al s t r at e gy
( ) Se ar c h or out s our c e d de ve l opment of ( , )f e as i bl e API pat e nt c os t
( Pharmac e ut i c al de ve l opment i nnovat i ve)t e c hnol ogi e s
Anal yt i c al de ve l opment & s t abi l i t y s t udi e s
Cl i ni c al de ve l opment
Manuf ac t ur i ng pr oc e s s de ve l opment
Pr e par at i on of r e gi s t r at i on f i l e s & f ol l ow up of r e gi s t r at i on pr oc e s s
Gene r i c Dos s i e r De ve l opment
EFARMES S.A.U.
Activities
Capabilities
The CompanyKey FactsOrganizational ChartBusiness Purpose
CollaborationsGeneric Dossier Develop Custom ManufacturingGeneric Supply
Efarmes Develop. Lab.Lacer Manufacturing Site
VIEW OUR PRODUCTS: genericlicensing.com/efarmes – DIRECT CONTACT
Cus t om Manuf ac t ur i ng
Fi ni s he d Dos age Form Capabi l i t i e s
EFARMES S.A.U.
Activities
Capabilities
The CompanyKey FactsOrganizational ChartBusiness Purpose
CollaborationsGeneric Dossier DevelopCustom ManufacturingGeneric Supply
Efarmes Develop. Lab.Lacer Manufacturing Site
: 30. 000 Tot al Ar e a m2
: 15. 000 Cons t r uc t e d m2
: 15. 000 Growt h pot e nt i al m2
: 140 Tot al St af f
: 30 Cl i e nt s di f f e r e ntc ompani e s : 25Count r i e s
• Figures
: 1. 200 Tabl e t s mi l l i on / uni t s ye ar
: 500 Caps ul e s mi l l i on uni t s/ ye ar - : 3. 500 Semi s ol i d f orms
/ t ons ye ar : 2. 500 / Li qui d f orms t onsye ar
• Ac t i vi t y
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Gene r i c Suppl y
Ef arme s s uppl i e s Gene r i c Fi ni s he d Dos age , Forms t o many ke y pl aye r s i nc l udi ng t he
:f ol l owi ng par t ne r s
GSK MYLAN RATI OPHARM / SANDOZ HEXAL STADA
…And many l oc al pl aye r s
EFARMES S.A.U.
Activities
Capabilities
The CompanyKey FactsOrganizational ChartBusiness Purpose
CollaborationsGeneric Dossier DevelopCustom ManufacturingGeneric Supply
Efarmes Develop. Lab.Lacer Manufacturing Site
VIEW OUR PRODUCTS: genericlicensing.com/efarmes – DIRECT CONTACT
Thank you f or !your at t e nt i on
VIEW OUR PRODUCTS: genericlicensing.com/efarmes – DIRECT CONTACT