ucus IIsr. JIra.

YKPAIHA
UKRAINE
CEPTI{OIKAT BIATIOBIAHOCTI YMOB BI{POEHI{IITBA JIIKAPCbKI4X 3ACOEIB BI{MOIAM
HAJIEXHOI BI4PO BH TIqOi IIPA-KTI{KH
CERTIFICATE OF GMP COMPLIANCE
Ceprnrlixar
Crpox aii ao: // Valid
N9: // Certificate No:
till:
18.09.2018
087/20I5ISAUMP/GMP
,{epxanna c,ryx6a Yrpaihu s lirapcrxux
3aco6iB (Aepxrixc.ryx6a Ynpaiiru) :lacein.Iye:
HaiiueHyaaH
H
n Bxpo6Hllxa.
M
icue3HaxoaxeHHfl
:
Iunaxy,.r Jlaiir[caiiencur IInr. "iIrA.,
cerurqe Taurenaa, Ponap PoyA, Haaarapx, oxpyr
CoraH [f .-il.], Iuair
Hafi ueuynaraa Bripo6Euqoi(ux)
Iun.rar.ry,r "lIaii{caiie ucus IIsr.
gi:rnHui(qr)
JIra.
Name(s) of manufacturing site(s):
Immacule Lifescieces Pvt. Ltd.
Manulacturing site address:
Vill. Thanthewal, Ropal Road, Nalagarh, Distt.
Solan IH.-P.], India
:
Micue npoaa4xeH H, .[irnbHocri :
ceflnue Tanrena,r, Ponap Poya, Ha,rarapx,
oKpyr CorraH [f .-fl.], luaia
JliqeH:iq Ha Bupo6nurlrBo nirapcr,Krrx 3aco6iB
lHaii sia 12.12.2013 X!MB/13/859 (Form 28)
Micqe erlpo6uullTBa cucreMarll.lHo
B
rrpoxoaflTb
iHcnexrlaauur ri sctaHog,Teuoto nepioauuuicrrc
Ha eiauosiAHicrT, Br'rMoraM GMP sriaso :ri
BCTaHOBJTeHT4M
State Administration of Ukraine on Medicinal
Products (SAUMP) confirms the follorving:
Manufacturer's name, registered place of business:
Immacule Lifescieces Pvt. Ltd.,
Vill. Thanthewal, Ropal Road, Nalagarh, Distt.
Solan [H.-P.], India
nOpr,4I{OM.
3a pe:yrrr,rarar,ur iucnerryeaHHr qr'oro
Bxpo6Hr4Ka, ocTaHHe s ffux 6y:ro IIpoBeaeHe
14.09.2015 - 18.09.2015,
BCTAHOBIEHO, UIO BiH BiANOtsi,UAE BI4MO|AM
HANEXHOI BI{P OE HIIqOi IIPA KTI,IKI,T,
Manulacturing authorization for medicinal
products in India lrom 12.12.2013 J\!MB/13/859
(Form 28)
Facilities of above mentioned manufacturer are
subject to GMP inspections at suitable intervals in
accordance witli the National certification
procedure.
From the knowledge gair.red druing inspection
this manufacturer. the latest of which was
conducted on
of
14.09.2015 - 18.09.2015,
it is considered that it complies with the
GOOD MANUFACTURING PRACTICE
reqllirements relerred to in the
3A3HAqCHIIM B
Hacranoei CT-H MO3y 42-4.0:2015 "Jlixapcrxi
3aco6lr.
Guide 42-4.0:2015 "Medicinal products. Good
HarexHa supo6Hllqa npaKtlrKa".
(1top anut6ttu oKtll)
3acrynrrur f o,rosH xoNricii :l peopraui:aqii
!,epNuurroi c-,r;x6u Ynpainu r ,rixapcuru x
Deputy Head of Commission on
reorglnization of the State Administration of
il ,Ukraine on Medicinal Products
r: . suvorova
snco6iB
I.M. Cynopona
/{ r./:/- r.{ 4/$ n,, a o
n, o
of Ilkraine on Medicinal Products
AepxaBHa c,1yr(6a yKpaiBx 3,'riKapcLKrx 3aco6iB
''i.'i-:' I i:
of tlre llxecuti\ e olJlcer' (sec lefl )
ni,rnuc ci.:lnoniaarlcHoi ocobu. neqaT xa
120. Peremogy avenue. K)'iv-l 15. t.Ikraine, 031 l5
AJpeca: rrpocriem flepeuora,120. u. KIaiB- I 15, ytcpaiua. 03115 ";-:i
2150- l2-66
+38(0,14)
Phone:
Ter. r 38(044) 450-12-66
Iax: +38(04,1) 450- l2-66
Oaxc: 38(044) 150-12-66
'lhis l-lnglish trirnslarion is lbr refcrence only and is not part ofthe
rnailto: diklz@dikiz.gov.ua
cenilicale
ollcial
ClopiHXa/CropiHodl/2
Pa?e/Pages
ulo BlAnoBIAaroTE
BHpo6HHurBi i
BUMOTaM Ha.Ire)I(HOl npaKTXKh
xourpori srcocri
npu
Cncre:utz
cnispo6iruuqrea $apuauearr.rvuax iHcnercqi[ (PIC/S),
,4upeKruBaM eC ra pexoueHAauisN,r BcecsirHsoi
oprauisauii oxopoHa 3aopoB'x si,qHocuo npolyxuii,
Luo npurHaLreHa.a,rr ropris,ri ra arzcrpuSluii s rpairli
roxor)(eHHq a6o 4ll excnopry.
Uen cepruQirar aigo6paxae craH eupo6r:uvoi
ai,rrsuui Ha MoMeHT iucnerryaauHa, 3a3HaqeHoro
Br,rue, i He Moxe BHKoprIcroByBarI,ICfl rJt\
nigueprxenxr ei,4nosianocri, cK[lo 3 ]\{oMeHry
npoBeaeHHq qroro iHcnerryaauu.r npoir-u,ro 6i,rrue
Hix 3 por<u.
l
Jeii ceprrzQixar rK;rroqae LracrlrHu l , 2 Ta Ao.qaroK.
Hurrsicrr uboro cepru(rixara Nloxe 5yrr
araraepAr(eHa opfaHoM,
uo Llofo
rlacrusa
which is lrarl.ronized with the requirenrents of Good
practices in the marufacture and quality control ofthe
Phamaceutical Inspection Convention/Co-operation
Scheme (PIC/S), EU Directives , and World Health
Organization recommendations in respect of products
to be sold or distributed within the county of origin or
to be expofied.
This certificate reflects the status ofthe manufacturing
site at tlie time ofthe inspection noted above and
shor.rld not be relied upon to reflect the compliance
status if mole than three years have elapsed since the
date of that inspection.
This certificate includes the Parts 1, 2 and Annex.
The authenticity ofthis certificate rnay be verified with
the issuing authority
BI1,qaB.
Ptrt
2
"lliraocrxi :aco6u r,'rq,'rroauuu
1. BI4POEHI,IIII OTIEPAIIII . JTIKAPCI,KI
3ACOEII
l.l. Crepu,rrsi flrroAyKTIr
l .l . l . Acenmu,luo GlrzomoqteHi (eupo6uuai
onepatlii dtn Hocmyntlux :tiKapcurux cfioptt)
1.1.1.4. Pi.{auu B yrraKoBxax ua-noro o6'euy
1.1.2. Illo niddarcmt cn xiu4eei cmepu-risa4ii
ptrpofittuui onepa4ii d.tn Ho(ntynltu.y .rirapt t,t;tt.r
2
Humnn Mcdicinal Products
1. MANUFACTURING OPERATIONS MEDICINAL I'RODUCTS
1.1. Sterile Products
1.1 .1 . Aseptically preparecl (processing oper(iions
fbr the fbllowins dosase /brms)
1 I. I .4. Sn-rall volume liquids
) .1.2. Terminally sterilised (processing operations
.lbr the .lbllotring tlosage .fbrms)
rbop.u)
1.1.2.3. Piaznu B ynar(oBr(ax Nrarroro 06'e\{y
(creprrnbHa Boaa,)ln, is r^r<uii:i s vr(ocri
po:uuuuuxa)
1.6. Ilpone4euHa nunpo6yeanr B pa rxax
ltout.po.nro nrcocri
1.6. l. Mircpo6io,roriuHi: cr epa,rsrr:c ru
1.6.3. <Di:laqni/xiuiqsi
3acrynuun lo,ronn KOMlcll 3
!epxauuoi c,r1,x6u Ynpaiuu
:aco6in
I.M. Cyaopoea
mailto: diklz@diklz.gov.ua
.2.3. Small volume liquids (sterile water for
injections as dissolvent)
1.1
I.6. Qualiff control testing
1.6.
l. Microbiological: steriliq,
I .6.3. Chemical/Physical
Dcputy Head of Commission on
reorganization of the State Administration of
Ukraine on Medicinal Products
I. Suvorova
is nor pan of the
CropiHX,/C ropiHod2/2
IIEPEJIIK JIIKAPCI,KIIX 3ACOBIB, 3APE€CTPOBA.HIIX AEO 3ATIJTAHOBAHIIX AO
PE€CTPAUII B YXPAIHI
LIST OF PRODUCTS, AUTHORISED ORPLANNED TO BE AUTHORISED IN UKRAINE
,{oaarox ao Cepru$ixara
Annex to Certificate 087/2015/SAUMP/GMP
Bl.[
from
/f,
//.
/E/6
Ilrruaxy,r .llaiit[caiieuclr: IIsr. "llrg.
Aapeca r.,t ic ur npoBanxeHH, nirnbHocri:
cerutqe Tanrena:r, Ponap Poya, Ha:rarapx, orpyr ConaH
Br4po6Hr.iK
manufacturer
Road, Nalagarh, Distt. Solan [H.-P.], India
Ao CepruQiKara
crpoKoM au ao
to Certificate 087/20f S/SAUMP/GMP
valid
Ha:na,rirancsnoro
till
18.09.2018
:raco6v
Mixuapogua
HEIIATCHTOBAHA HA3BA
Haona ra ,rinapcsrca
Hasna ra ,rinapcsrca
Qopua ,rixapcrrcoro
Qopiua ,rixapcrxoro
:aco6y
(yrpailrcr,lrorc nosorc)
I
UI{TIIKONIH,
an, iu'er<qii
ur/u:r
po3rrrrH
250
Iuaia
Immacule Lifescieces Pvt. Ltd.
Manufacturing site address :
Vill. Thanthewal, Ropal
J\!
zhr
[.-I.],
sircuoi(rx)
peuonlrxu(urr), y rolry
uuc,ri ik nepe,rix - g,rx
(aur,riiicrxom ruonoro)
6araroxounoneurrrux
(xolr6iHoeaulrx)
(anrriiicsroro uoeoro)
Bupoduuumao sa nogHlltt uuttto,M
:aco6y
CITICOLINE,
Citicoline
solution fbr injection
250 ms/ml
3acrynxur fo,roeN xorrricii : peopraui:aqii
[epxaaHoi c.nyx6u VxpaiH r.r r,rixapcsliux
3aco6iB
I.M. Cyaopoaa
Peecrpaqiiiue
nocsiaqeHHq
(roprona ,riqeusix)
J\!
_
(n Ynpaihi)
3an:raHoeaHo ao
peecrpaqii
Deputy Head of Commission on
. ', reorganization of the State Administration
.r . ol
of Ukraine on Medicinal Products
lt' lI. Suvorova
.l
4-{-r././.t4.o-1fiu,otootn
AeprraBHa c,,ry,I(6a yrpaiHtl ],,riKapcbxlrx iaco6iB
ni,qnrc BirlnoBi.qturLHoi oqo6u, fl eqarka
A.qpeca: npocnem llepeMoflr.120, M. Kl-riB-115. ykpaiHa, 03 I l5
Ter.: 38(044) 450-12-66
Oarc: 38(044) 450-12-66
mailto: diHz(@diklz.gov.ua
State Administration of [rkraine on Modicinal Products
signature ofthe Executive olficer (see left)
Address: 120, Peremogy avenue, Kyjv- I 1 5, Ukraine, 03 I l5
Phone: +38(044) 450-12-66
I.ax: +38(044) 450-12-66
This English translation is for refcrcncc only and is not part ofthe
official certifir:ate
Cropinxa/Cropirox/1/1
Page/Pages