S.C. FARMEX COMPANY S.R.L.

Adresa: Sat Pipera, Str. Drumul Potcoavei nr.30,Voluntari, Jud Ilfov

Tel.: 02 230!0!" # !$ %a&: 02 230!0!'# ()mail:
o*ce+farme& .ro
GENERAL PRESENTATION OF FARMEX COMPANY
Brief Information:
Farmex Company is a well known pharmaceutical company located 3 km near Bucharest, the
capital of Romania, in a residential area, on 5000 sqm. t was esta!lished in "##$ as the newest and
the most modern Romanian pharmaceutical manufacture. %he manufacturin& site, production team
and the headquarters as well are in the same area. %he company had !een licensed to manufacture
pharmaceutical products and food supplements for human use accordin& to the 'inistry of (ealth
in Romania.
Farmex Company has &ranted )'* Certificate !y competent authorities +,ational 'edicines
-&ency. in /005. %he company under&oes a continue impro0ement of manufacturin& efficiency
and re&ulatory compliance +c)'*..
n /00$ the )'* Certificate was renewed after ,ational 'edicines -&ency inspection in
conformity with 1uropean le&islation strictness.
Contact detail:
Com!an" 2C F-R'13 C4'*-,5 2R6
N#me : -imn 2i7ri
Addre: 2trada 8rumul *otcoa0ei nr. 30
Cit" : *ipera, 9oluntari, :udetul lfo0
Co#ntr" : Romania
Tele!$one: 00;0/" /30$0$<
Fa% : 00;0/" /30$0$5
E&mail : office=farmex .ro
Rele'ant acti'itie:
Acti'itie
(#man #e
medicine
(#man #e
medicine for clinic
in'eti)ation
Ra* material
for
man#fact#rin)
Food
#!!lement
'anufacturin&
3
>
> 3
-n&ro distri!ution
3
>
> 3
mport
>
>
3 >
1xport
3
>
> 3
4ther acti0ities
2tora&e
2econdary
packa&in&
2tora&e 2tora&e
T"!e of doa)e form man#fact#red on t$e ite:
Con0entional ta!lets and coated ta!lets.
-nti!iotics hard &elatin capsules.
Food supplements ta!lets and hard &elatin capsules.
"
S.C. FARMEX COMPANY S.R.L.
Adresa: Sat Pipera, Str. Drumul Potcoavei nr.30,Voluntari, Jud Ilfov
Tel.: 02 230!0!" # !$ %a&: 02 230!0!'# ()mail:
o*ce+farme& .ro
+ecri!tion of t$e man#fact#rin) ite:
%he production area of Farmex Company is located in a residential area named 9oluntari, without
pollutin& industrial acti0ities in the surroundin&s. %he company has en0ironmental appro0al and
complies with the le&al required conditions. n order to protect the en0ironment ha0e !een adopted
se0eral measures, such as?
> nstallation of exhaust filters@
> Concludin& a ser0ice contract for the disposal of all waste in en0ironmental conditions
resultin& from production acti0ities undertaken.
Farmex Company owns two !uildin&s?
> Block A A !uilt in /00", this includes?
> Buality control la!oratory for chemico>phisical analysis@
> 8edicated area for human use medicines for clinic in0esti&ation A secondary packa&in&@
> -dministrati0e area +offices, canteen, protocol room..
> Block B A !uilt in /00;, with the followin& acti0ities?
> Reception and stora&e of raw and packa&in& materials, and finished products@
> 'anufacturin& flows of products as follows?
Flow "? solid dosa&e forms A momodose A ta!lets, coated ta!lets, capsules
Flow /? solid dosa&e forms with C>lactamics anti!iotics > penicillins A monodose A ta!lets and
capsules@
> %echnical acti0ities of maintenance
%echnical area A (9-C units, heatin& system, purified water system@
%echnical area A chiller, power &enerators, and pressure control system@
Man#fact#re area , doa)e form !ac-a)in):
Solid Ot$er
4perations
+manufactureDpacka&in&.
'anufacture
*rimary packa&in&
2econdary
packa&in&
,um!er of rooms ;" "
%otal surface +m
/
.
;<",0# "$
Block B is !uilt with sandwich walls filled with polyurethane foam, and floors are of epoxy resin.
Classified area or processin& area are made of self le0elin& epoxy resin that maintains the dura!ility of the
area as well as cleana!ility and resistance to the chemicals. Finishin& of walls, floor, and ceilin& are smooth,
free from cracks and imper0ious to water and cleanin& and sanitiEin& a&ents. -ll ceilin& fixtures such as
li&ht fittin&s, air outlets and returns, and any other fittin&s are non>flakin&, corrosion resistant and
completely closed with a seamless plaster that assure ease of cleanin& and minimiEe the potential for
accumulation of dust. Ceilin&s are sealed to pre0ent contamination from the space.
%he (.AC system Eones cleaned is consisted of chiler, !oilers, distri!ution pumps and pipes, -ir
(andlin& Fnits and filters. Betalactam flow has separated -(Fs. n the clean rooms, the air
pressure in the fillin& rooms is hi&her than that in the surroundin& rooms for maintainin& the Eones
cleaned. n the other production areas, the corridors ha0e the hi&her air pressure compared to
/
S.C. FARMEX COMPANY S.R.L.
Adresa: Sat Pipera, Str. Drumul Potcoavei nr.30,Voluntari, Jud Ilfov
Tel.: 02 230!0!" # !$ %a&: 02 230!0!'# ()mail:
o*ce+farme& .ro
production rooms in order to a0oid the cross contaminations. n &eneral, the fresh air incomin&
from outside sucked throu&h the pre filter into the air handlin& unit then, cooled !y chilled water
or heated !y hot water@ after that, the comfort air passes throu&h the fine filter or (1*- filter !efore enterin&
the respecti0e room. %he air distri!utes inside the room !y ceilin& air diffusers and &rills.
Returned and exhaust air are taken throu&h &rills from the !ottom of rooms. 8ampers are installed on the air
ducts to control the air supply and maintain the air flow within the specified pressure and air flow ran&e. %he
exhaust air in some potent areas passes throu&h the air scru!!er to remo0e contamination from the 0ented
air.
*urified Gater system? *roduction of pharmaceutical dosa&e forms depends on the quality of water
that is used to formulate product or to clean equipment, and surfaces. Farmex Company is
supported with water treatment unit !ased on re0erse osmoses principle with a capacity of /000 m
3
per hour that is desi&ned to ha0e purified water accordin& to H1ur. *h.I.
N#m/er of em!lo"ee en)a)ed in t$e 0#alit" a#rance1 !rod#ction1 0#alit" control1
en)ineerin)1 tora)e and ditri/#tion:
8epartments B- BC *roduction 1n&ineerin& 2tora&eJ
8istri!ution
2upply
chain
1mployees
,um!er
3 3 "" 3 / "
S$ort decri!tion of t$e 0#alit" mana)ement "tem:
Farmex Company possesses a well>desi&ned assurance system, which includes concepts related to
rules of &ood manufacturin& practice, quality control, and risk mana&ement, which are interrelated.
Buality -ssurance system is constantly documented, mana&ed efficiently and pro0ides the
followin& requirements?
K Clear definition of desi&n and manufacturin& processes and control of medicinal products in
accordance with the requirements of rules of manufacturin& practice, the 'arketin& -uthoriEations
and their systemic re0iew in relation with the &ain experience, so as to ensure in a consistently way
the manufacture of medicinal products of the required quality in accordance with 2pecifications of
these.
K Clearly defined responsi!ilities and plannin& staff trainin& and professional qualification@
K 8e0elopin& and implementin& or&aniEational and re&istration of papers and documents traffic
control system@
K dentification and plannin& of all 0alidation acti0ities necessary to maintain critical operations
control aspects specific acti0ity, defined and documented in 'aster *lan 9alidation and
implementation of 0alidation andDor qualifications, processes, analytical methods, equipment,
installations, systems and facilities@
K 9erifyin& results re&istration of the sta&es of manufacturin& processes and quality control
performed on raw materials, packa&in& materials, intermediate products, !ulk and finished
products, after appro0al of their quality specifications@
K 1xistence of self inspection and quality audit procedure, assessin& at re&ular inter0als the
implementation and effecti0eness of Buality -ssurance.
3
S.C. FARMEX COMPANY S.R.L.
Adresa: Sat Pipera, Str. Drumul Potcoavei nr.30,Voluntari, Jud Ilfov
Tel.: 02 230!0!" # !$ %a&: 02 230!0!'# ()mail:
o*ce+farme& .ro
K Ban on the sale or distri!ution of medicinal products !efore the qualified person certifyin& that
each !atch was manufactured and controlled as required !y 'arketin& -uthoriEation and any other
re&ulation re&ardin& production, control and release of the medicinal products.
K -ppropriate measures so that the stora&e, shipment and su!sequent handlin& of medicinal
products to !e carried out in conditions which ensure their quality and to maintain the 0alidity
period
K *eriodical ela!oration of quality re0iew of all authoriEed products, includin& products intended
for export, the existin& process to 0erify consistency, fairness current specifications for !oth raw
materials and finished product, to detect any trend and to identify ways to impro0e product and
process. 2uch tests are performed and documented annually, takin& into account pre0ious
assessments.
Bualified person responsi!le for final certification of the !atches, certifies that quality analyses are
approached in a appropriate manner and that is correct.
K 2upplier auditin&? %he suppliers of critical startin& and packa&in& materials are annually audited.
-cti0e pharmaceutical in&redients and excipients, containers, closures and printed packa&in&
materials are assessed as per the written appro0ed procedures.
-ll these ar&uments lead to the conclusion that implemented quality assurance system has a
complete documentation, and effecti0eness is monitored and documented.
Peronnel:
%o up&rade the skills of the plant personnel with a 0iew to achie0e !etter standards. %rainin& of all
personnel in the areas of production, quality control, en&ineerin&, and plant administration. is
carried out in the followin& fields?
Current Good Manufacturing Practices: this trainin& is imparted to all personnel on a
continuous !asis.
Technical training is &i0en on the 7o! that the employee has to perform. -wareness of the
technical trainin& is &i0en on an annual !asis.
The efficacy of Training is assessed throu&h trainin& e0aluation form after each lecture and
throu&h auditin& and inspection reports that e0aluate the performance of the employee.
8ependin& on auditin& and inspection reports, incident reports, complaint reports and
performance analysis reports. Retraining needs are identified.
Records of training are maintained for each employee.
Or)ani)ram:
-n or&ani&ram shows the arran&ements for quality assurance, includin& production and quality
control, as follows?
;
S.C. FARMEX COMPANY S.R.L.
Adresa: Sat Pipera, Str. Drumul Potcoavei nr.30,Voluntari, Jud Ilfov
Tel.: 02 230!0!" # !$ %a&: 02 230!0!'# ()mail: o*ce+farme& .ro
5
S.C. FARMEX COMPANY S.R.L.
Adresa: Sat Pipera, Str. Drumul Potcoavei nr.30,Voluntari, Jud Ilfov
Tel.: 02 230!0!" # !$ %a&: 02 230!0!'# ()mail:
o*ce+farme& .ro
(ealt$ Re0#irement for Peronnel En)a)ed in Prod#ction:
4nly 1mployees who are healthy and free from any conta&ious or infectious diseases are en&a&ed
in production, quality control and in maintenance area. %his is ensured throu&h?
*re employment medical examination.
- pri0ate doctor on contract !asis checks health of the employees.
Gashin& area and chan&in& room facilities are a0aila!le
Peronnel (")iene Re0#irement:
Farmex Company facilities are equipped with well maintained chan&in& rooms that include lockers.
toilets, showers, hand washin& tu!s, and hand dryers.
)owns and suits are made of clothes, and shoes that satisfy safety and comforta!le workin&
en0ironment. *rotecti0e equipment is defined accordin& to workin& area of non sterile products
with classified clean room, &rade 8 as follows?
Protecti'e
e0#i!ment for
O!eration
Foot Bod" (and (ead
,on>sterile
manufacture
8edicated shoes
for classified area
*rotecti0e suit 2in&le use &lo0es
> 2in&le use cap
> 2in&le use mask
2econdary packa&in&
8edicated shoes
for controlled area
+non classified.
*rotecti0e suit > 2in&le use cap
Githdrawin& samples
8edicated shoes
for classified area
*rotecti0e suit 2in&le use &lo0es 2in&le use cap
Buality Control 6a! 8edicated shoes *rotecti0e &rown
2in&le use &lo0es
+when applica!le.
2in&le use mask
+when applica!le.
4ther +warehouse,
technicalDmaintenance.
8edicated shoes *rotecti0e suit 2pecial &lo0es >
-ll detail of personnel protecti0e equipment, and details for &uests, are descri!ed in the dedicated
24*s.
Goal of Farme% Com!an":
n /00" the company started manufacturin& and promotin& &eneric products? -mpicillin Forte 500
m&, 4xacillin Forte 500 m&, and -moxicillin Forte 500 m&, followed in the next years of a
continuously de0elopin& of new products.
%he )'* standards are strictly applied startin& from the receipt of the raw materials from relia!le
which are strictly tested accordin& to the international standards and endin& up with safe and
effecti0e finished product.
%he company represents a well>esta!lished or&aniEation and has a professionally mana&ed system,
usin& the latest and hi&hest technolo&ies !ased on complete 0alidated documentation to !e a!le to
pro0ide to our patients, customers and partners safety, efficacy, easy access, pleasant 0iew, hi&h
quality, low prices finished products.
<
S.C. FARMEX COMPANY S.R.L.
Adresa: Sat Pipera, Str. Drumul Potcoavei nr.30,Voluntari, Jud Ilfov
Tel.: 02 230!0!" # !$ %a&: 02 230!0!'# ()mail:
o*ce+farme& .ro
n time with manufacturin& updates, Farmex Company is in full process of de0elopin& the portfolio
and is mainly interested in stren&then the actual products position on the market, !y its sales and
marketin& team.
2trate&ic colla!orations with many partners put the company on a solid foundation on which to
&row, and to de0elop its portfolio.
t is FarmexLs ma7or priority to extend the international relations also as supplier of &oods or
ser0ices. n /00$ Farmex started to export products in 6i!ya, and it is &oin& to extend its external
acti0ity in? Repu!lic of 'oldo0a, Russia, -Eer!ai7an, -l!ania, taly and any other country.
FarmexLs 9alue statement defines the way we Beha0e, Gork, and nteract shapin& a !etter future
to&ether with our partners.
M
S.C. FARMEX COMPANY S.R.L.
Adresa: Sat Pipera, Str. Drumul Potcoavei nr.30,Voluntari, Jud Ilfov
Tel.: 02 230!0!" # !$ %a&: 02 230!0!'# ()mail:
o*ce+farme& .ro
FARMEX COMPANY2S PORTFOLIO
ME+ICINAL PRO+3CTS
Nr4
crt4
Name of t$e !rod#ct
54 PARACETAMOL FARMEX 677 m) ta/let
Box x / !listers x "0 ta!lets
84 PIRACETAM FARMEX 977 m)1 ta/let
Box x ; !listers x "0 ta!lets
:4 CAPTOPRIL FARMEX 86 m) ta/let
Box x / !listers x "0 ta!lets
94 ANTIGRIPAL PC1 ta/let
Box x / !listers x "0 ta!lets
*aracetamol 500 m&, Cafeine anhydrous 50 m&
64
NIMES3LI+ FARMEX 577 m)1 ta/let
Box x " !lister x "0 ta!lets
;4 <ETOCONA=OL FARMEX 877 m)1 ta/let
Box x " !lister x "0 ta!lets
>4 OXACILINA FORTE 677 m)1 ca!#le
Box x / !listers x "0 capsules
?4 AMPICILINA FORTE 677 m)1 ca!#le
Box x / !listers x "0 capsules
Box x " !lister x "0 capsules
@4 AMOXICILINA FORTE 677 m)1 ca!#le
Box x / !listers x "0 capsules
Box x " !lister x "0 capsules
574
OMEPRA=OL FARMEX 87 m)1 ca!#le
)atroreitant
Box x 3 !listers x "0 capsules &astroresistant
554 CARBAMA=EPINA FARMEX 877 m) ta/let
Box x / !listers x "0 ta!lets
584 BE=AFIBRAT FARMEX 877 m)1 ta/let
Box x / !listers x "0 ta!lets
5:4 ACICLO.IR FARMEX 877 m) ca!#le
Box x / !listers x "0 capsules
594 ITRACONA=OL FARMEX 577 m)1 ca!#le
Box x 3 !listers x 5 capsules
$
S.C. FARMEX COMPANY S.R.L.
Adresa: Sat Pipera, Str. Drumul Potcoavei nr.30,Voluntari, Jud Ilfov
Tel.: 02 230!0!" # !$ %a&: 02 230!0!'# ()mail:
o*ce+farme& .ro
FOO+ S3PLEMENTS
Nr4
Crt4
Name of t$e !rod#ct
54
ARTROFARM 3 !listers x "0 capsules
>Chondroitin sulfat "00 m&
>)lucoEamin /50 m&
>metilsulfonilmetan 50 m&
84
GINSENG 67 m) 3 !listers x "0 capsules
>extract )insen& radix
$0 N &insenoside O 50 m&
:4
GASTRO ACTI. 3 !listers x "0 capsules
>1xtr. -loe 9era "00 m&
>1xtr.Calendula /00 m&
>1xtr.(ypericum perforatum >"00 m&
94
ANTIOSTEOPOROTIC 3 !listers x "0 capsules
>1xtr.%rifolium pretense ;0 N isofla0one O /5 m&
>*owder of oyster equi0alent to 3$ N Ca O ;00 m&
64
ANTIOXI+ANT3 !listers x "0capsules
1xtr.0itis 0inifera A 50 m&
;4
PROPFARM 3 !listers x "0 chewa!le ta!lets
&1xtract *ropolis >"<0 m&
>4
RENAL ACTI. 3 !listers x "0 capsules
&1xtract %hymus 0ul&aris >"00 m&
1xtract 9accinum 0itis idaea A "00 m&
1xtract Calluna 0ul&aris A 50 m&
?4
GIN<GO BILOBA 97 m) 3 !listers x "0 capsules
1xtr.)ink&o>!ilo!a /; N )ink&o>fla0one O ;0 m&
@4
MENOFARM 3 !listers x "0 capsules
>1xtract 2oy iEofla0one >"00 m&
574
MARINE CALCI3M OF OYSTER A .IT +: 3 !listers
x"0 capsules
>*owder of oyster ;00 m& equi0alent to 3$ m& Ca
>9itamin 83>"00 F
554
AYSLIM FARM 3 !listers x "0 capsules
>1xtract (oodia &ordonii A 350 m&
584
NEBCARE < !listers x 5 soft &elatin capsules
9itamin B" "0 m&,
Calciu pantotenate <0 m&,
6>cystine /0 m&,
'edicinal yeast "00 m&,
Peratin /0 m&,
p>amino!enEoic acid /0 m&.
5:4
TRI=YME / !listers x "0 soft &elatin capsules
*ancreatine "00 m& +amilaEe "00 ,FFDm&, protease "00
,FFDm&, 6ipase $ ,FFDm&.
594
SPASMOCOLON / !listers x "0 soft &elatin capsules
2odium dehidrocolat /0 m&,
8imethicone ;0 m&,
)lutamic acid "00 m&,
*ancreatine "50 m&,
CelulaEe /0 m&,
*epsine << m&,
'ethixe (Cl " m&
564
PEPONIL 3 !listers x "0 soft &elatin capsules
*umpkin seed oil 300 m&
5;4
BANTEX 3 !listers x "0 soft &elatin capsules
-lfa>pinen /;,$ m&,
Beta>pinen <,/ m&,
Camphen "5 m&,
Borneol "0 m&,
-netol ; m&,
Fenchon ; m&,
Cineol 3 m&,
2oy oil $3 m&
5>4
3LTRA.IT M syrup /00 ml
#