Efarmes (Spain) company presentation

LACER GROUP

EFARMES

VIEW OUR PRODUCTS ON

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

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

REGULATORY AFFAIRS

GALENI CALDEVELOPMEN

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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