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Insulin Glulisine

Suanfarma, at the Core of a Better Life.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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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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2 Actylis
1 BASF
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2 Seppic

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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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2 Surfactant & Foaming Agents
1 Emulsifying Agents
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2 US Medicaid Prescriptions, 11 Finished Drug Prices, 8 Annual Reports

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11 Finished Drug Prices
8 Annual Reports

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8 Health Canada Patents

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Synopsis

ACTIVE PHARMA INGREDIENTS

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FDF

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FINISHED DOSAGE FORMULATIONS

29

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3

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16

Europe

3

Canada

3

Australia

4

South Africa

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Annual Reports (USD Million)

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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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ABOUT THIS PAGE

Insulin Glulisine Manufacturers

A Insulin Glulisine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Insulin Glulisine, including repackagers and relabelers. The FDA regulates Insulin Glulisine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Insulin Glulisine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Insulin Glulisine Suppliers

A Insulin Glulisine supplier is an individual or a company that provides Insulin Glulisine active pharmaceutical ingredient (API) or Insulin Glulisine finished formulations upon request. The Insulin Glulisine suppliers may include Insulin Glulisine API manufacturers, exporters, distributors and traders.

Insulin Glulisine GMP

Insulin Glulisine Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Insulin Glulisine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Insulin Glulisine GMP manufacturer or Insulin Glulisine GMP API supplier for your needs.

Insulin Glulisine CoA

A Insulin Glulisine CoA (Certificate of Analysis) is a formal document that attests to Insulin Glulisine's compliance with Insulin Glulisine specifications and serves as a tool for batch-level quality control.

Insulin Glulisine CoA mostly includes findings from lab analyses of a specific batch. For each Insulin Glulisine CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Insulin Glulisine may be tested according to a variety of international standards, such as European Pharmacopoeia (Insulin Glulisine EP), Insulin Glulisine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Insulin Glulisine USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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