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Insulin Glulisine

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FINISHED DOSAGE FORMULATIONS

29 FDF Dossiers, 3 FDA Orange Book, 16 Europe, 3 Canada, 3 Australia, 4 South Africa

29 FDF Dossiers
3 FDA Orange Book
16 Europe
3 Canada
3 Australia
4 South Africa

RELATED EXCIPIENT COMPANIES

1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 Capital Farma, 2 Actylis, 1 BASF, 1 BioSpectra, 2 Seppic

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1 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 Capital Farma
2 Actylis
1 BASF
1 BioSpectra
2 Seppic

EXCIPIENTS BY APPLICATIONS

7 Parenteral, 4 Solubilizers, 3 Topical, 2 Surfactant & Foaming Agents, 1 Emulsifying Agents, 1 Thickeners and Stabilizers

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7 Parenteral
4 Solubilizers
3 Topical
2 Surfactant & Foaming Agents
1 Emulsifying Agents
1 Thickeners and Stabilizers

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GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 11 Finished Drug Prices, 8 Annual Reports

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2 US Medicaid Prescriptions
11 Finished Drug Prices
8 Annual Reports

PATENTS & EXCLUSIVITIES

8 Health Canada Patents

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8 Health Canada Patents

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

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CEP/COS

CEP/COS Certifications

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NDC API

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Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 0

MARKET PLACE

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API

0

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

29

FDF Dossiers

3

FDA Orange Book

FDA (Orange Book)

16

Europe

3

Canada

3

Australia

4

South Africa

0

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

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USP

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JP

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Others

PATENTS & EXCLUSIVITIES

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US Patents

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US Exclusivities

8

Health Canada Patents

DIGITAL CONTENT

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Data Compilation #PharmaFlow

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Weekly News Recap #Phispers

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GLOBAL SALES INFORMATION

US Medicaid (USD)

12,232,754

Annual Reports (USD Million)

3,389

Finished Drug Prices

9 RELATED EXCIPIENT COMPANIES

18EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as:

Molecular Formula

C₂₅₈H₃₈₄N₆₄O₇₈S₆

Molecular Weight

5823 g/mol

InChI Key

RCHHVVGSTHAVPF-ZPHPLDECSA-N

Insulin Glulisine

1 2D Structure

Insulin Glulisine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(4S)-4-[[2-[[(1R,6R,12S,15S,18S,21S,24S,27S,30S,33S,36S,39S,42R,47R,50S,53S,56S,59S,62S,65S,68S,71S,74R,77S,80S,83S,88R)-88-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S,3S)-2-[(2-aminoacetyl)amino]-3-methylpentanoyl]amino]-3-methylbutanoyl]amino]-4-carboxybutanoyl]amino]-5-oxopentanoyl]amino]-6-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-amino-3-phenylpropanoyl]amino]-3-methylbutanoyl]amino]hexanoyl]amino]-5-oxopentanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-4-methylpentanoyl]amino]-47-[[(1S)-3-amino-1-carboxy-3-oxopropyl]carbamoyl]-53-(2-amino-2-oxoethyl)-62-(3-amino-3-oxopropyl)-77-[(2S)-butan-2-yl]-24,56-bis(2-carboxyethyl)-83-[(1R)-1-hydroxyethyl]-12,71,80-tris(hydroxymethyl)-33,50,65-tris[(4-hydroxyphenyl)methyl]-15-(1H-imidazol-5-ylmethyl)-27-methyl-18,30,36,59,68-pentakis(2-methylpropyl)-7,10,13,16,19,22,25,28,31,34,37,40,49,52,55,58,61,64,67,70,73,76,79,82,85,87-hexacosaoxo-21,39-di(propan-2-yl)-3,4,44,45,90,91-hexathia-8,11,14,17,20,23,26,29,32,35,38,41,48,51,54,57,60,63,66,69,72,75,78,81,84,86-hexacosazabicyclo[72.11.7]dononacontane-42-carbonyl]amino]acetyl]amino]-5-[[(2S)-5-carbamimidamido-1-[[2-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S,3R)-1-[(2S)-2-[[(2S)-4-carboxy-1-[[(1S,2R)-1-carboxy-2-hydroxypropyl]amino]-1-oxobutan-2-yl]carbamoyl]pyrrolidin-1-yl]-3-hydroxy-1-oxobutan-2-yl]amino]-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-2-oxoethyl]amino]-1-oxopentan-2-yl]amino]-5-oxopentanoic acid

2.1.2 InChI

InChI=1S/C258H384N64O78S6/c1-29-132(23)206(313-193(338)105-260)253(394)317-205(131(21)22)250(391)289-160(75-83-200(348)349)219(360)283-157(71-79-190(264)335)223(364)308-184-117-404-405-118-185-244(385)305-179(112-324)241(382)295-164(90-124(7)8)227(368)296-170(97-141-53-61-147(329)62-54-141)230(371)284-156(70-78-189(263)334)220(361)291-163(89-123(5)6)225(366)285-159(74-82-199(346)347)222(363)303-176(103-191(265)336)236(377)299-172(99-143-57-65-149(331)66-58-143)233(374)309-183(243(384)304-177(256(397)398)104-192(266)337)116-403-402-115-182(215(356)273-108-194(339)278-154(72-80-197(342)343)218(359)281-152(51-42-86-271-258(267)268)213(354)272-109-195(340)279-168(95-139-46-36-32-37-47-139)229(370)298-169(96-140-48-38-33-39-49-140)232(373)300-173(100-144-59-67-150(332)68-60-144)239(380)320-209(136(27)327)255(396)322-87-43-52-187(322)247(388)286-161(76-84-201(350)351)224(365)321-210(137(28)328)257(399)400)311-251(392)204(130(19)20)316-237(378)166(92-126(11)12)293-231(372)171(98-142-55-63-148(330)64-56-142)297-226(367)162(88-122(3)4)290-211(352)134(25)277-216(357)158(73-81-198(344)345)288-249(390)203(129(17)18)315-238(379)167(93-127(13)14)294-235(376)175(102-146-107-270-121-276-146)302-240(381)178(111-323)280-196(341)110-274-214(355)181(114-401-406-119-186(310-245(184)386)246(387)319-208(135(26)326)254(395)306-180(113-325)242(383)318-207(133(24)30-2)252(393)312-185)307-228(369)165(91-125(9)10)292-234(375)174(101-145-106-269-120-275-145)301-221(362)155(69-77-188(262)333)282-217(358)153(50-40-41-85-259)287-248(389)202(128(15)16)314-212(353)151(261)94-138-44-34-31-35-45-138/h31-39,44-49,53-68,106-107,120-137,151-187,202-210,323-332H,29-30,40-43,50-52,69-105,108-119,259-261H2,1-28H3,(H2,262,333)(H2,263,334)(H2,264,335)(H2,265,336)(H2,266,337)(H,269,275)(H,270,276)(H,272,354)(H,273,356)(H,274,355)(H,277,357)(H,278,339)(H,279,340)(H,280,341)(H,281,359)(H,282,358)(H,283,360)(H,284,371)(H,285,366)(H,286,388)(H,287,389)(H,288,390)(H,289,391)(H,290,352)(H,291,361)(H,292,375)(H,293,372)(H,294,376)(H,295,382)(H,296,368)(H,297,367)(H,298,370)(H,299,377)(H,300,373)(H,301,362)(H,302,381)(H,303,363)(H,304,384)(H,305,385)(H,306,395)(H,307,369)(H,308,364)(H,309,374)(H,310,386)(H,311,392)(H,312,393)(H,313,338)(H,314,353)(H,315,379)(H,316,378)(H,317,394)(H,318,383)(H,319,387)(H,320,380)(H,321,365)(H,342,343)(H,344,345)(H,346,347)(H,348,349)(H,350,351)(H,397,398)(H,399,400)(H4,267,268,271)/t132-,133-,134-,135+,136+,137+,151-,152-,153-,154-,155-,156-,157-,158-,159-,160-,161-,162-,163-,164-,165-,166-,167-,168-,169-,170-,171-,172-,173-,174-,175-,176-,177-,178-,179-,180-,181-,182-,183-,184-,185-,186-,187-,202-,203-,204-,205-,206-,207-,208-,209-,210-/m0/s1

2.1.3 InChI Key

RCHHVVGSTHAVPF-ZPHPLDECSA-N

2.1.4 Canonical SMILES

CCC(C)C1C(=O)NC2CSSCC(C(=O)NC(CSSCC(C(=O)NCC(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(CSSCC(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC2=O)CO)CC(C)C)CC3=CC=C(C=C3)O)CCC(=O)N)CC(C)C)CCC(=O)O)CC(=O)N)CC4=CC=C(C=C4)O)C(=O)NC(CC(=O)N)C(=O)O)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CC5=CC=CC=C5)C(=O)NC(CC6=CC=CC=C6)C(=O)NC(CC7=CC=C(C=C7)O)C(=O)NC(C(C)O)C(=O)N8CCCC8C(=O)NC(CCC(=O)O)C(=O)NC(C(C)O)C(=O)O)C(C)C)CC(C)C)CC9=CC=C(C=C9)O)CC(C)C)C)CCC(=O)O)C(C)C)CC(C)C)CC2=CN=CN2)CO)NC(=O)C(CC(C)C)NC(=O)C(CC2=CN=CN2)NC(=O)C(CCC(=O)N)NC(=O)C(CCCCN)NC(=O)C(C(C)C)NC(=O)C(CC2=CC=CC=C2)N)C(=O)NC(C(=O)NC(C(=O)N1)CO)C(C)O)NC(=O)C(CCC(=O)N)NC(=O)C(CCC(=O)O)NC(=O)C(C(C)C)NC(=O)C(C(C)CC)NC(=O)CN

2.1.5 Isomeric SMILES

CC[C@H](C)[C@H]1C(=O)N[C@H]2CSSC[C@@H](C(=O)N[C@@H](CSSC[C@@H](C(=O)NCC(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H](NC2=O)CO)CC(C)C)CC3=CC=C(C=C3)O)CCC(=O)N)CC(C)C)CCC(=O)O)CC(=O)N)CC4=CC=C(C=C4)O)C(=O)N[C@@H](CC(=O)N)C(=O)O)C(=O)NCC(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)N[C@@H](CC5=CC=CC=C5)C(=O)N[C@@H](CC6=CC=CC=C6)C(=O)N[C@@H](CC7=CC=C(C=C7)O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N8CCC[C@H]8C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H]([C@@H](C)O)C(=O)O)C(C)C)CC(C)C)CC9=CC=C(C=C9)O)CC(C)C)C)CCC(=O)O)C(C)C)CC(C)C)CC2=CN=CN2)CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC2=CN=CN2)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H](CCCCN)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC2=CC=CC=C2)N)C(=O)N[C@H](C(=O)N[C@H](C(=O)N1)CO)[C@@H](C)O)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](C(C)C)NC(=O)[C@H]([C@@H](C)CC)NC(=O)CN

2.2 Create Date

2014-03-02

3 Chemical and Physical Properties

Molecular Formula	C₂₅₈H₃₈₄N₆₄O₇₈S₆
Molecular Weight	5823 g/mol
XLogP3	-12.1
Hydrogen Bond Donor Count	78
Hydrogen Bond Acceptor Count	90
Rotatable Bond Count	180
Exact Mass	5820.6440255 g/mol
Monoisotopic Mass	5818.6373159 g/mol
Topological Polar Surface Area	2450 Å²
Heavy Atom Count	406
Formal Charge	0
Complexity	14600
Isotope Atom Count	0
Defined Atom Stereocenter Count	52
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Apidra
Drug Label	APIDRA (insulin glulisine [rDNA origin] injection) is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12...
Active Ingredient	Insulin glulisine recombinant
Dosage Form	Injectable
Route	Iv (infusion), subcutaneous
Strength	300 units/3ml (100 units/ml); 1000 units/10ml (100 units/ml)
Market Status	Prescription
Company	Sanofi Aventis Us

2 of 4
Drug Name	Apidra solostar
PubMed Health	Insulin Glulisine (Injection)
Drug Classes	Antidiabetic
Drug Label	APIDRA (insulin glulisine [rDNA origin] injection) is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12...
Active Ingredient	Insulin glulisine recombinant
Dosage Form	Injectable
Route	Subcutaneous
Strength	300 units/3ml
Market Status	Prescription
Company	Sanofi Aventis Us

3 of 4
Drug Name	Apidra
Drug Label	APIDRA (insulin glulisine [rDNA origin] injection) is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12...
Active Ingredient	Insulin glulisine recombinant
Dosage Form	Injectable
Route	Iv (infusion), subcutaneous
Strength	300 units/3ml (100 units/ml); 1000 units/10ml (100 units/ml)
Market Status	Prescription
Company	Sanofi Aventis Us

4 of 4
Drug Name	Apidra solostar
PubMed Health	Insulin Glulisine (Injection)
Drug Classes	Antidiabetic
Drug Label	APIDRA (insulin glulisine [rDNA origin] injection) is a rapid-acting human insulin analog used to lower blood glucose. Insulin glulisine is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12...
Active Ingredient	Insulin glulisine recombinant
Dosage Form	Injectable
Route	Subcutaneous
Strength	300 units/3ml
Market Status	Prescription
Company	Sanofi Aventis Us

FDF Dossiers

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Finished Drug Prices

01

Brand Name : Apidra

France

Medlab Asia & Asia Health

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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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France

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RX/OTC/DISCN : Class A

SANOFI AVENTIS DEUTSCHL.GMBH

Insulin Glulisine

Dosage Form : Insulin Glulisine 1.000Iu 10Ml 1...

Dosage Strength : 1 vial SC 10 ml 100 IU/ml

Price Per Pack (Euro) : 32.93

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Country : Italy

RX/OTC/DISCN : Class A

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02

Brand Name : Apidra

France

Medlab Asia & Asia Health

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France

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RX/OTC/DISCN : Class B

Sanofi-Aventis (Switzerland) SA

Insulin Glulisine

Dosage Form : Inj Loose

Dosage Strength :

Price Per Pack (Euro) : 22.62

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Country : Switzerland

RX/OTC/DISCN : Class B

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03

Brand Name : Apidra SoloStar

France

Medlab Asia & Asia Health

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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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France

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RX/OTC/DISCN : Class B

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Insulin Glulisine

Dosage Form : Inj Loose

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Price Per Pack (Euro) : 31.7

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Country : Switzerland

RX/OTC/DISCN : Class B

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04

Brand Name : Apidra

France

Medlab Asia & Asia Health

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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Contact Supplier

France

Digital Content

RX/OTC/DISCN : Class B

Sanofi-Aventis (Switzerland) SA

Insulin Glulisine

Dosage Form : Inj Loose Optipen/Cliksta/Junior...

Dosage Strength :

Price Per Pack (Euro) : 37.28

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Country : Switzerland

RX/OTC/DISCN : Class B

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Brand Name : Apidra

France

Medlab Asia & Asia Health

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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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France

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RX/OTC/DISCN :

Sanofi-Aventis Looks Deutschland Gm...

Insulin Glulisine

Dosage Form : Injection fluid, resolution

Dosage Strength : 100 E/ml

Price Per Pack (Euro) : 27.038

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Country : Norway

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06

Brand Name : Apidra

France

Medlab Asia & Asia Health

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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Contact Supplier

France

Digital Content

RX/OTC/DISCN :

Sanofi-Aventis Looks Deutschland Gm...

Insulin Glulisine

Dosage Form : Injection fluid, resolution

Dosage Strength : 100 E/ml

Price Per Pack (Euro) : 41.481

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RX/OTC/DISCN :

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Digital Content

07

Brand Name : Apidra

France

Medlab Asia & Asia Health

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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Contact Supplier

France

Digital Content

RX/OTC/DISCN :

Sanofi-Aventis Looks Deutschland Gm...

Insulin Glulisine

Dosage Form : Injection fluid, resolution in s...

Dosage Strength : 100 E/ml

Price Per Pack (Euro) : 41.481

Published in :

Country : Norway

RX/OTC/DISCN :

Sanofi Company Banner

Portfolio PDF

Product Web Link

Digital Content

08

Brand Name : Apidra

France

Medlab Asia & Asia Health

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

Contact Supplier

France

Digital Content

RX/OTC/DISCN :

Sanofi-Aventis Looks Deutschland Gm...

Insulin Glulisine

Dosage Form : Injection fluid, resolution in t...

Dosage Strength : 100 E/ml

Price Per Pack (Euro) : 45.474

Published in :

Country : Norway

RX/OTC/DISCN :

Sanofi Company Banner

Portfolio PDF

Product Web Link

Digital Content

09

Brand Name : Apidra

France

Medlab Asia & Asia Health

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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Contact Supplier

France

Digital Content

RX/OTC/DISCN :

Sanofi-Aventis Looks Deutschland Gm...

Insulin Glulisine

Dosage Form : Injection fluid, resolution in t...

Dosage Strength : 100 E/ml

Price Per Pack (Euro) : 46.673

Published in :

Country : Norway

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Brand Name : Apidra

France

Medlab Asia & Asia Health

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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Contact Supplier

France

Digital Content

RX/OTC/DISCN : Class A

SANOFI AVENTIS DEUTSCHL.GMBH

Insulin Glulisine

Dosage Form : Insulin Glulisine 300Iu 3Ml 5 Un...

Dosage Strength : 5 cartridges SC 3 ml 300 IU

Price Per Pack (Euro) : 49.39

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