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    Chemistry

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    Also known as: Gtpl7572, Hoe901, Hoe-901
    Molecular Formula
    C267H404N72O78S6
    Molecular Weight
    6063  g/mol
    InChI Key
    COCFEDIXXNGUNL-RFKWWTKHSA-N
    Insulin Glargine
    A recombinant LONG ACTING INSULIN and HYPOGLYCEMIC AGENT that is used to manage BLOOD GLUCOSE in patients with DIABETES MELLITUS.
    1 2D Structure

    Insulin Glargine

    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)-4-amino-2-[[(2S)-2-[[(2S)-2-amino-3-phenylpropanoyl]amino]-3-methylbutanoyl]amino]-4-oxobutanoyl]amino]-5-oxopentanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]amino]-4-methylpentanoyl]amino]-53-(2-amino-2-oxoethyl)-62-(3-amino-3-oxopropyl)-77-[(2S)-butan-2-yl]-24,56-bis(2-carboxyethyl)-47-(carboxymethylcarbamoyl)-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)-1-[[2-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S,3R)-1-[(2S)-2-[[(2S)-6-amino-1-[[(2S,3R)-1-[[(2S)-5-carbamimidamido-1-[[(1S)-4-carbamimidamido-1-carboxybutyl]amino]-1-oxopentan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1-oxohexan-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]-5-carbamimidamido-1-oxopentan-2-yl]amino]-5-oxopentanoic acid
    2.1.2 InChI
    InChI=1S/C267H404N72O78S6/c1-29-137(23)212(330-199(355)109-269)260(412)334-211(136(21)22)256(408)305-166(79-86-206(365)366)226(378)298-163(75-82-196(273)352)230(382)326-190-122-421-422-123-191-251(403)322-185(117-341)249(401)312-170(94-129(7)8)234(386)313-176(101-146-57-65-152(346)66-58-146)237(389)299-161(73-80-194(271)350)227(379)308-169(93-128(5)6)232(384)301-165(78-85-205(363)364)229(381)320-182(107-197(274)353)244(396)316-178(103-148-61-69-154(348)70-62-148)240(392)325-188(222(374)290-115-207(367)368)120-418-420-121-189(221(373)288-112-200(356)294-160(76-83-203(359)360)225(377)297-157(53-42-88-284-265(276)277)219(371)287-113-201(357)295-174(99-144-48-36-32-37-49-144)236(388)315-175(100-145-50-38-33-39-51-145)239(391)317-179(104-149-63-71-155(349)72-64-149)247(399)338-216(142(28)345)263(415)339-91-45-56-193(339)254(406)302-158(52-40-41-87-268)231(383)336-214(140(26)343)261(413)303-159(54-43-89-285-266(278)279)224(376)306-167(264(416)417)55-44-90-286-267(280)281)328-258(410)210(135(19)20)333-245(397)172(96-131(11)12)310-238(390)177(102-147-59-67-153(347)68-60-147)314-233(385)168(92-127(3)4)307-217(369)139(25)293-223(375)164(77-84-204(361)362)304-255(407)209(134(17)18)332-246(398)173(97-132(13)14)311-242(394)181(106-151-111-283-126-292-151)319-248(400)184(116-340)296-202(358)114-289-220(372)187(119-419-423-124-192(327-252(190)404)253(405)337-215(141(27)344)262(414)323-186(118-342)250(402)335-213(138(24)30-2)259(411)329-191)324-235(387)171(95-130(9)10)309-241(393)180(105-150-110-282-125-291-150)318-228(380)162(74-81-195(272)351)300-243(395)183(108-198(275)354)321-257(409)208(133(15)16)331-218(370)156(270)98-143-46-34-31-35-47-143/h31-39,46-51,57-72,110-111,125-142,156-193,208-216,340-349H,29-30,40-45,52-56,73-109,112-124,268-270H2,1-28H3,(H2,271,350)(H2,272,351)(H2,273,352)(H2,274,353)(H2,275,354)(H,282,291)(H,283,292)(H,287,371)(H,288,373)(H,289,372)(H,290,374)(H,293,375)(H,294,356)(H,295,357)(H,296,358)(H,297,377)(H,298,378)(H,299,389)(H,300,395)(H,301,384)(H,302,406)(H,303,413)(H,304,407)(H,305,408)(H,306,376)(H,307,369)(H,308,379)(H,309,393)(H,310,390)(H,311,394)(H,312,401)(H,313,386)(H,314,385)(H,315,388)(H,316,396)(H,317,391)(H,318,380)(H,319,400)(H,320,381)(H,321,409)(H,322,403)(H,323,414)(H,324,387)(H,325,392)(H,326,382)(H,327,404)(H,328,410)(H,329,411)(H,330,355)(H,331,370)(H,332,398)(H,333,397)(H,334,412)(H,335,402)(H,336,383)(H,337,405)(H,338,399)(H,359,360)(H,361,362)(H,363,364)(H,365,366)(H,367,368)(H,416,417)(H4,276,277,284)(H4,278,279,285)(H4,280,281,286)/t137-,138-,139-,140+,141+,142+,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-,188-,189-,190-,191-,192-,193-,208-,209-,210-,211-,212-,213-,214-,215-,216-/m0/s1
    2.1.3 InChI Key
    COCFEDIXXNGUNL-RFKWWTKHSA-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)NCC(=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(CCCCN)C(=O)NC(C(C)O)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)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(CC(=O)N)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)NCC(=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](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCCNC(=N)N)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](CC(=O)N)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 Synonyms
    2.2.1 MeSH Synonyms

    1. 901, Hoe

    2. A21 Gly B31 Arg B32 Arg Insulin

    3. A21-gly-b31-arg-b32-arg-insulin

    4. Basaglar

    5. Glargine

    6. Glargine, Insulin

    7. Glargine-aglr, Insulin

    8. Hoe 901

    9. Hoe-901

    10. Hoe901

    11. Insulin Glargine

    12. Insulin Glargine-aglr

    13. Insulin Glargine-yfgn

    14. Insulin, Gly(a21)-arg(b31,b32)

    15. Insulin, Glycyl(a21)-arginyl(b31,b32)

    16. Lantus

    17. Lantus Solostar

    18. Rezvoglar

    19. Semglee

    20. Solostar, Lantus

    2.2.2 Depositor-Supplied Synonyms

    1. Gtpl7572

    2. Hoe901

    3. Hoe-901

    2.3 Create Date
    2009-08-20
    3 Chemical and Physical Properties
    Molecular Weight 6063 g/mol
    Molecular Formula C267H404N72O78S6
    XLogP3-14.1
    Hydrogen Bond Donor Count85
    Hydrogen Bond Acceptor Count92
    Rotatable Bond Count191
    Exact Mass6060.8251182 g/mol
    Monoisotopic Mass6058.8184085 g/mol
    Topological Polar Surface Area2590 Ų
    Heavy Atom Count423
    Formal Charge0
    Complexity15300
    Isotope Atom Count0
    Defined Atom Stereocenter Count53
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameLantus
    PubMed HealthInsulin Glargine
    Drug ClassesAntidiabetic, Insulin, Long Acting
    Drug LabelLANTUS (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenter...
    Active IngredientInsulin glargine recombinant
    Dosage FormInjectable
    RouteInjection
    Strength100 units/ml
    Market StatusPrescription
    CompanySanofi Aventis Us

    2 of 2  
    Drug NameLantus
    PubMed HealthInsulin Glargine
    Drug ClassesAntidiabetic, Insulin, Long Acting
    Drug LabelLANTUS (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenter...
    Active IngredientInsulin glargine recombinant
    Dosage FormInjectable
    RouteInjection
    Strength100 units/ml
    Market StatusPrescription
    CompanySanofi Aventis Us

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Hypoglycemic Agents

    Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)

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    Rev. Date :

    Pay. Date :

    DMF Number : 27093

    Submission : 2013-05-24

    Status : Active

    Type : II

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    Submission : 2022-02-16

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    Submission : 2025-05-21

    Status : Active

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    Insulin glargine (recombinant)

    Registration Number : 226MF10213

    Registrant's Address : Biocon House, Ground Floor, Tower-3, Semicon Park, Electronic City, Phase-II, Hosur R...

    Initial Date of Registration : 2014-11-17

    Latest Date of Registration : 2019-01-24

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    INSULIN GLARGINE

    NDC Package Code : 52221-125

    Start Marketing Date : 2020-08-26

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    NDC Package Code : 65727-023

    Start Marketing Date : 2005-01-01

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    NDC Package Code : 85893-002

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    Insulin Glargine

    About the Company : Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are pro...

    Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are proud to be the leading company in the Asia-Pacific region that successfully researched and developed Active Pharmaceutical Ingredients (APIs) and specific therapeutic products on the foundation of advanced recombinant DNA/protein technology.
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    Insulin Glargine

    About the Company : NINGBO INNO PHARMCHEM CO.,LTD. develop, pilot and commercial produce organic chemicals, pharmaceutical intermediates and nutraceuticals. We also offer custom synthesis and manufact...

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    Drugs in Development

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

    A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus

    Details:

    Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.


    Lead Product(s): Insulin Glargine,Lixisenatide

    Therapeutic Area: Endocrinology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Peptide, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 04, 2024

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    Sanofi

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

    Lead Product(s) : Insulin Glargine,Lixisenatide

    Therapeutic Area : Endocrinology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mel...

    Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.

    Product Name : Undisclosed

    Product Type : Peptide, Unconjugated

    Upfront Cash : Inapplicable

    December 04, 2024

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

    iGlarLixi CGM Study in Chinese T2D Individuals After OADs

    Details:

    Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.


    Lead Product(s): Insulin Glargine,Lixisenatide

    Therapeutic Area: Endocrinology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Peptide, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 04, 2024

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    Sanofi

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

    Lead Product(s) : Insulin Glargine,Lixisenatide

    Therapeutic Area : Endocrinology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    iGlarLixi CGM Study in Chinese T2D Individuals After OADs

    Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.

    Product Name : Undisclosed

    Product Type : Peptide, Unconjugated

    Upfront Cash : Inapplicable

    November 04, 2024

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

    Sanofi Launches New Long-Acting Insulin Drug in India

    Details:

    Soliqua is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. It is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes.


    Lead Product(s): Insulin Glargine,Lixisenatide

    Therapeutic Area: Endocrinology Brand Name: Soliqua

    Study Phase: Approved FDFProduct Type: Peptide, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 27, 2023

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    Sanofi

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

    Lead Product(s) : Insulin Glargine,Lixisenatide

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Sanofi Launches New Long-Acting Insulin Drug in India

    Details : Soliqua is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. It is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes.

    Product Name : Soliqua

    Product Type : Peptide, Unconjugated

    Upfront Cash : Inapplicable

    March 27, 2023

    Sanofi Company Banner

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    Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)

    Details:

    Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.


    Lead Product(s): Insulin Glargine,Inapplicable

    Therapeutic Area: Endocrinology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Peptide, Unconjugated

    Sponsor: Mira Zuidgeest

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 22, 2023

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    Sanofi

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

    Lead Product(s) : Insulin Glargine,Inapplicable

    Therapeutic Area : Endocrinology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Mira Zuidgeest

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)

    Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.

    Product Name : Undisclosed

    Product Type : Peptide, Unconjugated

    Upfront Cash : Inapplicable

    March 22, 2023

    Sanofi Company Banner

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

    Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment

    Details:

    Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.


    Lead Product(s): Insulin Glargine,Inapplicable

    Therapeutic Area: Endocrinology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Peptide, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 23, 2022

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    Sanofi

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

    Lead Product(s) : Insulin Glargine,Inapplicable

    Therapeutic Area : Endocrinology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment

    Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.

    Product Name : Undisclosed

    Product Type : Peptide, Unconjugated

    Upfront Cash : Inapplicable

    September 23, 2022

    Sanofi Company Banner

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    iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

    Details:

    Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diabetes Mellitus, Type 2.


    Lead Product(s): Insulin Glargine,Lixisenatide,Metformin

    Therapeutic Area: Endocrinology Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Peptide, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 10, 2022

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    Sanofi

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

    Lead Product(s) : Insulin Glargine,Lixisenatide,Metformin

    Therapeutic Area : Endocrinology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

    Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diabetes Mellitus, Type 2.

    Product Name : Undisclosed

    Product Type : Peptide, Unconjugated

    Upfront Cash : Inapplicable

    June 10, 2022

    Sanofi Company Banner

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    • Development Update
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus

    Details:

    Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.


    Lead Product(s): Insulin Glargine,Lixisenatide

    Therapeutic Area: Endocrinology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Peptide, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 10, 2021

    Sanofi Company Banner

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    Sanofi

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

    Lead Product(s) : Insulin Glargine,Lixisenatide

    Therapeutic Area : Endocrinology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Pati...

    Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.

    Product Name : Undisclosed

    Product Type : Peptide, Unconjugated

    Upfront Cash : Inapplicable

    November 10, 2021

    Sanofi Company Banner

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

    A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extens...

    Details:

    Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.


    Lead Product(s): Insulin Glargine,Inapplicable

    Therapeutic Area: Endocrinology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Peptide, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 12, 2021

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    Sanofi

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

    Lead Product(s) : Insulin Glargine,Inapplicable

    Therapeutic Area : Endocrinology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncon...

    Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.

    Product Name : Undisclosed

    Product Type : Peptide, Unconjugated

    Upfront Cash : Inapplicable

    August 12, 2021

    Sanofi Company Banner

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    Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on ...

    Details:

    Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.


    Lead Product(s): Insulin Glargine,Inapplicable

    Therapeutic Area: Endocrinology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Peptide, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 28, 2021

    Sanofi Company Banner

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    Sanofi

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

    Lead Product(s) : Insulin Glargine,Inapplicable

    Therapeutic Area : Endocrinology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve P...

    Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.

    Product Name : Undisclosed

    Product Type : Peptide, Unconjugated

    Upfront Cash : Inapplicable

    July 28, 2021

    Sanofi Company Banner

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    New Soliqua® Data Shows Improved Blood Sugar Control Without Weight Gain Versus Premixed Insulin

    Details:

    Participants were randomized to switch from their prior insulin to either Soliqua once daily or premixed insulin twice daily, with starting doses determined and adjusted weekly. Any metformin or SGLT-2i treatment was maintained through the study period.


    Lead Product(s): Insulin Glargine,Lixisenatide

    Therapeutic Area: Endocrinology Brand Name: Soliqua

    Study Phase: UndisclosedProduct Type: Peptide, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 28, 2021

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    Sanofi

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

    Lead Product(s) : Insulin Glargine,Lixisenatide

    Therapeutic Area : Endocrinology

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    New Soliqua® Data Shows Improved Blood Sugar Control Without Weight Gain Versus Premixed Insulin

    Details : Participants were randomized to switch from their prior insulin to either Soliqua once daily or premixed insulin twice daily, with starting doses determined and adjusted weekly. Any metformin or SGLT-2i treatment was maintained through the study period.

    Product Name : Soliqua

    Product Type : Peptide, Unconjugated

    Upfront Cash : Inapplicable

    June 28, 2021

    Sanofi Company Banner

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    EUROAPI

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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Regulatory Info : Prescription

    Registration Country : Denmark

    Insulin Glargine

    Brand Name : Lantus Optiset

    Dosage Form : Injectable Solution

    Dosage Strength : 100 U/ml

    Packaging :

    Approval Date : 06-02-2001

    Application Number : 28103247201

    Regulatory Info : Prescription

    Registration Country : Denmark

    EUROAPI Compnay Banner

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    EUROAPI

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    Booth #1525
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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Regulatory Info : Prescription

    Registration Country : Denmark

    Insulin Glargine

    Brand Name : Lantus Solostar

    Dosage Form : Solution For Injection

    Dosage Strength : 100 U/ml

    Packaging :

    Approval Date : 01-09-2006

    Application Number : 28104219807

    Regulatory Info : Prescription

    Registration Country : Denmark

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    03

    EUROAPI

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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Flag France
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    Regulatory Info : Prescription

    Registration Country : Denmark

    Insulin Glargine

    Brand Name : Lantus

    Dosage Form : Injection Solution

    Dosage Strength : 100 units/ml

    Packaging :

    Approval Date : 09-06-2000

    Application Number : 28103089899

    Regulatory Info : Prescription

    Registration Country : Denmark

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    04

    EUROAPI

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    Booth #1525
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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Flag France
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    Regulatory Info : Prescription

    Registration Country : Denmark

    Insulin Glargine

    Brand Name : Lantus

    Dosage Form : Solution For Injection

    Dosage Strength : 100 units/ml

    Packaging :

    Approval Date : 09-06-2000

    Application Number : 28103065399

    Regulatory Info : Prescription

    Registration Country : Denmark

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    05

    EUROAPI

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    Booth #1525
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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Flag France
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    Regulatory Info : Prescription

    Registration Country : Denmark

    Insulin Glargine

    Brand Name : Lantus Opticlik

    Dosage Form : Solution For Injection

    Dosage Strength : 100 units/ml

    Packaging :

    Approval Date : 31-08-2004

    Application Number : 28103637404

    Regulatory Info : Prescription

    Registration Country : Denmark

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    06

    Sanofi

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

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    Regulatory Info :

    Registration Country : USA

    INSULIN GLARGINE RECOMBINANT

    Brand Name : LANTUS

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 100 UNITS/ML

    Packaging :

    Approval Date :

    Application Number : 21081

    Regulatory Info :

    Registration Country : USA

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    Sanofi

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

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    Regulatory Info :

    Registration Country : USA

    INSULIN GLARGINE RECOMBINANT

    Brand Name : LANTUS SOLOSTAR

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 300 UNITS/3ML (100 UNITS/ML)

    Packaging :

    Approval Date :

    Application Number : 21081

    Regulatory Info :

    Registration Country : USA

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    Sanofi

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

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    Regulatory Info :

    Registration Country : USA

    INSULIN GLARGINE RECOMBINANT

    Brand Name : TOUJEO SOLOSTAR

    Dosage Form : SOLUTION;SUBCUTANEOUS

    Dosage Strength : 450 UNITS/1.5ML (300 UNITS/ML)

    Packaging :

    Approval Date :

    Application Number : 206538

    Regulatory Info :

    Registration Country : USA

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    Sanofi

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

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    Regulatory Info :

    Registration Country : USA

    INSULIN GLARGINE RECOMBINANT

    Brand Name : TOUJEO MAX SOLOSTAR

    Dosage Form : SOLUTION;SUBCUTANEOUS

    Dosage Strength : 900 UNITS/3ML (300 UNITS/ML)

    Packaging :

    Approval Date :

    Application Number : 206538

    Regulatory Info :

    Registration Country : USA

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    10

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    INSULIN GLARGINE; LIXISENATIDE

    Brand Name : SOLIQUA 100/33

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    Dosage Strength : 300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML)

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    Aventis Pharma Deutschland Gmbh

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    Insulin Glargine

    Brand Name : Lantus Optiset

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    Insulin Glargine

    Brand Name : Lantus Solostar

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    Approval Date : 01-09-2006

    Application Number : 28104219807

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    Insulin Glargine

    Brand Name : Lantus

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    Approval Date : 09-06-2000

    Application Number : 28103089899

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    Aventis Pharma Deutschland Gmbh

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    Insulin Glargine

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    Approval Date : 09-06-2000

    Application Number : 28103065399

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    Insulin Glargine

    Brand Name : Lantus Opticlik

    Dosage Form : Solution For Injection

    Dosage Strength : 100 units/ml

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    Approval Date : 31-08-2004

    Application Number : 28103637404

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    Glargine

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    Dosage Form : Insulin Glargine 1.000Iu 10Ml 1 Units Parenteral Use

    Dosage Strength : 1 vial SC 1,000 IU 10 ml

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    Insulin Glargine

    Brand Name : Lantus

    Dosage Form : Injectable Solution In Cartridge

    Dosage Strength : 3.6378mg/ml

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    Approval Date : 16/05/2002

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    Regulatory Info : Authorized

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    Insulin Glargine

    Brand Name : Toujeo

    Dosage Form : Solostar Injectable Solution In Pre-Filled Pen

    Dosage Strength : 300UNIT

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    Approval Date : 11-05-2015

    Application Number : 100133034

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    Sanofi Winthrop Industrie

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    Insulin Glargin; Lixisenatid

    Brand Name : Suliqua

    Dosage Form : Solution For Injection

    Dosage Strength : 100IU/ml; 50mcg/ml

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    Approval Date : 11-01-2017

    Application Number : 28105754016

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    Regulatory Info : Approved

    Registration Country : Sweden

    Insulin Glargine

    Brand Name : Lantus

    Dosage Form : Injectable Solution

    Dosage Strength : 100units/ml

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    Approval Date : 09-06-2000

    Application Number : 2.00E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    ABOUT THIS PAGE

    Looking for / Insulin Glargine API manufacturers, exporters & distributors?

    Insulin Glargine manufacturers, exporters & distributors 1

    97

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

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Insulin Glargine manufacturer or Insulin Glargine supplier.

    API | Excipient name

    Insulin Glargine

    Synonyms

    Gtpl7572, Hoe901, Hoe-901

    About Insulin Glargine

    A recombinant LONG ACTING INSULIN and HYPOGLYCEMIC AGENT that is used to manage BLOOD GLUCOSE in patients with DIABETES MELLITUS.

    INSULIN GLARGINE (RDNA ORIGIN) Manufacturers

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

    click here to find a list of INSULIN GLARGINE (RDNA ORIGIN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

    INSULIN GLARGINE (RDNA ORIGIN) Suppliers

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

    click here to find a list of INSULIN GLARGINE (RDNA ORIGIN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

    INSULIN GLARGINE (RDNA ORIGIN) USDMF

    A INSULIN GLARGINE (RDNA ORIGIN) DMF (Drug Master File) is a document detailing the whole manufacturing process of INSULIN GLARGINE (RDNA ORIGIN) active pharmaceutical ingredient (API) in detail. Different forms of INSULIN GLARGINE (RDNA ORIGIN) DMFs exist exist since differing nations have different regulations, such as INSULIN GLARGINE (RDNA ORIGIN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A INSULIN GLARGINE (RDNA ORIGIN) DMF submitted to regulatory agencies in the US is known as a USDMF. INSULIN GLARGINE (RDNA ORIGIN) USDMF includes data on INSULIN GLARGINE (RDNA ORIGIN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The INSULIN GLARGINE (RDNA ORIGIN) USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of INSULIN GLARGINE (RDNA ORIGIN) suppliers with USDMF on PharmaCompass.

    INSULIN GLARGINE (RDNA ORIGIN) JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The INSULIN GLARGINE (RDNA ORIGIN) Drug Master File in Japan (INSULIN GLARGINE (RDNA ORIGIN) JDMF) empowers INSULIN GLARGINE (RDNA ORIGIN) API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the INSULIN GLARGINE (RDNA ORIGIN) JDMF during the approval evaluation for pharmaceutical products. At the time of INSULIN GLARGINE (RDNA ORIGIN) JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of INSULIN GLARGINE (RDNA ORIGIN) suppliers with JDMF on PharmaCompass.

    INSULIN GLARGINE (RDNA ORIGIN) NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing INSULIN GLARGINE (RDNA ORIGIN) as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for INSULIN GLARGINE (RDNA ORIGIN) API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture INSULIN GLARGINE (RDNA ORIGIN) as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain INSULIN GLARGINE (RDNA ORIGIN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a INSULIN GLARGINE (RDNA ORIGIN) NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of INSULIN GLARGINE (RDNA ORIGIN) suppliers with NDC on PharmaCompass.

    INSULIN GLARGINE (RDNA ORIGIN) GMP

    INSULIN GLARGINE (RDNA ORIGIN) 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 GLARGINE (RDNA ORIGIN) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right INSULIN GLARGINE (RDNA ORIGIN) GMP manufacturer or INSULIN GLARGINE (RDNA ORIGIN) GMP API supplier for your needs.

    INSULIN GLARGINE (RDNA ORIGIN) CoA

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

    INSULIN GLARGINE (RDNA ORIGIN) CoA mostly includes findings from lab analyses of a specific batch. For each INSULIN GLARGINE (RDNA ORIGIN) 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 GLARGINE (RDNA ORIGIN) may be tested according to a variety of international standards, such as European Pharmacopoeia (INSULIN GLARGINE (RDNA ORIGIN) EP), INSULIN GLARGINE (RDNA ORIGIN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (INSULIN GLARGINE (RDNA ORIGIN) 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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