PEOPLE'S REPUBLIC OF CHINA

CER TIFICATE OF A PHARMACEUTICAL PRODUCT

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( Pharmaceutical Product Approved in China )

This certificate confonns to the format recommended by the World Health Organization.
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fil~~-'% t:p)(: ;ñ: 20190175

(Certificate No.) ~X: JS20190175
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Importing Country ~)(: The Republic of Cameroon, Benin, epal, Republic
/Region (Requesting of Togo, Republic of Guinea, Republic of Garner,
Country /Region) Senegal, Nigeria, Gabon, Mali, Burkina Faso, Republic
of Cote d' Ivoire, Madagascar, Congo, Republic of Costa
Rica, Peru
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Name and Dosages Form
of the Product ~)(: Salbutamol Sulfate Inhaltion Aerosol Aerosol

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Trade Name
~)(: Not Applicable
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Active lngredient(s) and
Strength[Not disclosed to ~)(: Salbutamol lOOmcg/dose
the public]
 9l>C: ~~~~1ifit~rJ;T~M 24mg, ffl~Jif-tJ;TH3iM 20mg; -:k
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:ñtfi~ C15Jllf:f*) [::fxt li~~l3üU!i~ C94%) 5mg (J}?,.f_;t.ffi~t:E1HH~-it.ffl); xll(Z,ff
7'~0:Jfl lml; immz:.m 14. 28g.
For complete ~)(: Each canister contains: Salbutamol sulfate 24mg,
composition including
equivalent to Salbutamol 20mg; Soya phosphatidyl
excipients,see
choli ne (94%) 5mg (involved in Pretreatment of
attached[Not disclosed to
the public] salbutamol sulfate): Ethanol lml; Tetrafluoroethane
14. 28g.

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Is this product strength :l% (Yes) e .¡ )
licensed to be placed on
the market for use in the
exporting country

~Fj~~~~~B~:{:E ~ (Yes) e .¡ )
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Is this product strength
~ (No) e )
actually on the market in
exporting country
¡x ~mm x Ji;- e 1* t4 Fj
.¡.~-'%) ,&_jttftt ( .¡.~)
i:p)(: IE~t'l=E-* H20123384 2012-12-11
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Number of product
~)(: 2012--12-11
license (DMF number)
and date of issue
tp)(: ~j+lrñ~~*~FjiJ~0'iiJ
~~
Fj ~ ~.;n: :íblt~;¡-Fj~ Name ~Jt: Yangzhou No. 3 Pharmaceutical Co., Ltd.
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Manufacturer or
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Product-license ±&hl
holder(name and address) ~)(: No. 51 Guotai Road, Yil ing Town, Jiangdu
Address
Are a, Yangzhou City

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cturer
lf the license holder is
not the manufacturer, the 'fl )l:
name and address of the
manufacturer producing ±&hl
~Jt:
the dosage form is Address
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Does the certifying ~ (Yes) ( .J )
authority arrange for
periodic inspections of
the manufacturing plant
in which the dosage fonn
is produced

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Periodicity of routine 1
inspections (years)

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Do the facilities and
operations confonn to the
requirements of Chinese
GMP
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This is to certify that the above product(s) comply with the relevant standards of the P. R.
China, have been registered and authorized to be sold in China. The exportation of the
roduct(s) is not restricted.
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This certificate 2021-06-02
remain valid until

f6 ~
Name ~:t: JIANGSU DRUG ADMINISTRATIO

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Address
~:t: No.5 Gulou Street, Nanjing,
Jiangsu Province
eg i!
025-83209367
Tele hone number
Certifying authority 1! Ji
Fax

Si ature
~il-!:5 BM
Stamp and date