Efarmes (Spain) company presentation

LACER GROUP

EFARMES

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EFARMES S.A.U.

Capabilities Activities

The CompanyKey FactsOrganizational ChartBusiness Purpose

Efarmes Development Lab.Lacer Manufacturing Site

CollaborationsGeneric Dossier Develop Custom ManufacturingGeneric Supply

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Our Mi s s i on

EFARMES S.A.U.

Activities

Capabilities


CollaborationsGeneric Dossier DevelopCustom ManufacturingGeneric Supply

Efarmes Develop. Lab.Lacer Manufacturing Site



/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






PROFI LE

The Company

EFARMES S.A.U.

Activities

Capabilities






EFARMES S.A.U.

Activities

Capabilities




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



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






: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






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






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






: 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






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


CollaborationsGeneric Dossier Develop Custom ManufacturingGeneric Supply




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




: 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



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






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