menu
    • menu

    Find Pramlintide manufacturers, exporters & distributors on PharmaCompass

    Evonik

    Virtual Booth

    Contact Supplier

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

    Virtual Booth

    Contact Supplier

    Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

    Virtual Booth

    Contact Supplier

    With Fermion, start the journey of your innovative API.

    Virtual Booth

    Contact Supplier

    Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

    Virtual Booth

    Contact Supplier

    Temad- We think of world-class quality.

    Virtual Booth

    Contact Supplier

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    REF. STANDARDS & IMPURITIES

    PharmaCompass

    Synopsis

    Product SearchProduct Search

    Synopsis

    ACTIVE PHARMA INGREDIENTS

    11

    API Suppliers

    API Suppliers

    3

    USDMF

    US DMFs Filed

    0

    CEP/COS

    CEP/COS Certifications

    0

    JDMF

    JDMFs Filed

    0

    EU WC

    EU WC

    0

    KDMF

    KDMF

    3

    NDC API

    NDC API

    0

    VMF

    NDC API

    5

    Listed Suppliers

    Other Suppliers

    0INTERMEDIATES

    REF. STANDARDS OR IMPURITIES

    0

    EDQM

    0

    USP

    0

    JP

    2

    Others

    FINISHED DOSAGE FORMULATIONS

    3

    FDF Dossiers

    FDF Dossiers

    3

    FDA Orange Book

    FDA (Orange Book)

    0

    Europe

    Europe

    0

    Canada

    Canada

    0

    Australia

    Australia

    0

    South Africa

    South Africa

    0

    Listed Dossiers

    Listed Dossiers

    11DRUGS IN DEVELOPMENT

    FDF DossiersDRUG PRODUCT COMPOSITIONS

    32RELATED EXCIPIENT COMPANIES

    70EXCIPIENTS BY APPLICATIONS

    PATENTS & EXCLUSIVITIES

    0

    US Patents

    0

    US Exclusivities

    0

    Health Canada Patents

    API REF. PRICE (USD/KG)

    $
    $ 4,679,430

    GLOBAL SALES INFORMATION

    US Medicaid

    4,050,756

    Annual Reports

    82

    Regulatory FDF Prices

    Listed Dossiers
    API/FDF Prices: Book a Demo to
    explore the features and consider
    upgrading later

    MARKET PLACE

    1

    API

    0

    FDF

    DIGITAL CONTENT

    1

    Data Compilation #PharmaFlow

    0

    Stock Recap #PipelineProspector

    0

    Weekly News Recap #Phispers

    0

    News #PharmaBuzz

    Chemistry

    Click the arrow to open the dropdown
    read-moreClick the button for full data set
    read-moreClick the button for full data set
    Also known as: Pramlintide acetate [usan], Schembl238214, Unii-726i6te06g, Aco137, 726i6te06g, 25-l-proline-28-l-proline-29-l-proline-, acetate (salt), hydrate
    Molecular Formula
    C171H269N51O53S2
    Molecular Weight
    3951  g/mol
    InChI Key
    NRKVKVQDUCJPIZ-MKAGXXMWSA-N
    Pramlintide
    Pramlintide Acetate is the acetate salt form of pramlintide, a peptide analogue of human amylin with 3 proline substitutions at position 25, 28 and 29, with antihyperglycemic activity. By mimicking amylin, pramlintide slows gastric emptying, inhibits digestive secretions (gastric acid, pancreatic enzymes, and bile), reduces glucagon secretion, and increases satiety; all of these actions are mediated mostly by glucose-sensitive areas in the brain stem. The overall result is a decrease in blood glucose levels. The use of pramlintide may cause an increased risk of insulin-induced hypoglycemia.
    1 2D Structure

    Pramlintide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-N-[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(2S)-4-amino-1-[[(2S)-1-[[2-[(2S)-2-[[(2S,3S)-1-[[(2S)-1-[(2S)-2-[(2S)-2-[[(2S,3R)-1-[[(2S)-4-amino-1-[[(2S)-1-[[2-[[(2S)-1-[[(2S)-4-amino-1-[[(2S,3R)-1-[[(2S)-1-amino-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-2-oxoethyl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]carbamoyl]pyrrolidine-1-carbonyl]pyrrolidin-1-yl]-4-methyl-1-oxopentan-2-yl]amino]-3-methyl-1-oxopentan-2-yl]carbamoyl]pyrrolidin-1-yl]-2-oxoethyl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-(1H-imidazol-5-yl)-1-oxopropan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-1-oxopropan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-5-carbamimidamido-1-oxopentan-2-yl]-2-[[(2S,3R)-2-[[(2S)-2-[[(2R)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-4-amino-2-[[(2R)-2-[[(2S)-2,6-diaminohexanoyl]amino]-3-sulfanylpropanoyl]amino]-4-oxobutanoyl]amino]-3-hydroxybutanoyl]amino]propanoyl]amino]-3-hydroxybutanoyl]amino]-3-sulfanylpropanoyl]amino]propanoyl]amino]-3-hydroxybutanoyl]amino]pentanediamide
    2.1.2 InChI
    InChI=1S/C171H269N51O53S2/c1-21-81(12)130(163(268)207-110(56-78(6)7)169(274)222-53-33-42-118(222)170(275)221-52-32-41-117(221)160(265)219-135(89(20)230)167(272)206-109(66-125(180)238)151(256)212-128(79(8)9)161(266)186-68-126(239)192-111(70-223)154(259)203-107(64-123(178)236)152(257)218-134(88(19)229)166(271)195-98(136(181)241)57-92-43-45-94(231)46-44-92)214-159(264)116-40-31-51-220(116)127(240)69-187-141(246)101(58-90-34-24-22-25-35-90)199-148(253)105(62-121(176)234)201-149(254)106(63-122(177)235)202-155(260)112(71-224)209-156(261)113(72-225)208-146(251)103(60-93-67-184-75-188-93)205-162(267)129(80(10)11)213-150(255)100(55-77(4)5)198-145(250)102(59-91-36-26-23-27-37-91)200-147(252)104(61-120(175)233)196-137(242)82(13)189-144(249)99(54-76(2)3)197-142(247)96(39-30-50-185-171(182)183)193-143(248)97(47-48-119(174)232)194-165(270)132(86(17)227)215-138(243)83(14)190-157(262)114(73-276)211-168(273)133(87(18)228)216-139(244)84(15)191-164(269)131(85(16)226)217-153(258)108(65-124(179)237)204-158(263)115(74-277)210-140(245)95(173)38-28-29-49-172/h22-27,34-37,43-46,67,75-89,95-118,128-135,223-231,276-277H,21,28-33,38-42,47-66,68-74,172-173H2,1-20H3,(H2,174,232)(H2,175,233)(H2,176,234)(H2,177,235)(H2,178,236)(H2,179,237)(H2,180,238)(H2,181,241)(H,184,188)(H,186,266)(H,187,246)(H,189,249)(H,190,262)(H,191,269)(H,192,239)(H,193,248)(H,194,270)(H,195,271)(H,196,242)(H,197,247)(H,198,250)(H,199,253)(H,200,252)(H,201,254)(H,202,260)(H,203,259)(H,204,263)(H,205,267)(H,206,272)(H,207,268)(H,208,251)(H,209,261)(H,210,245)(H,211,273)(H,212,256)(H,213,255)(H,214,264)(H,215,243)(H,216,244)(H,217,258)(H,218,257)(H,219,265)(H4,182,183,185)/t81-,82-,83-,84-,85+,86+,87+,88+,89+,95-,96-,97-,98-,99-,100-,101-,102-,103-,104-,105-,106-,107-,108-,109-,110-,111-,112-,113-,114-,115-,116-,117-,118-,128-,129-,130-,131-,132-,133-,134-,135-/m0/s1
    2.1.3 InChI Key
    NRKVKVQDUCJPIZ-MKAGXXMWSA-N
    2.1.4 Canonical SMILES
    CCC(C)C(C(=O)NC(CC(C)C)C(=O)N1CCCC1C(=O)N2CCCC2C(=O)NC(C(C)O)C(=O)NC(CC(=O)N)C(=O)NC(C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(CC(=O)N)C(=O)NC(C(C)O)C(=O)NC(CC3=CC=C(C=C3)O)C(=O)N)NC(=O)C4CCCN4C(=O)CNC(=O)C(CC5=CC=CC=C5)NC(=O)C(CC(=O)N)NC(=O)C(CC(=O)N)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CC6=CN=CN6)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC7=CC=CC=C7)NC(=O)C(CC(=O)N)NC(=O)C(C)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(CCC(=O)N)NC(=O)C(C(C)O)NC(=O)C(C)NC(=O)C(CS)NC(=O)C(C(C)O)NC(=O)C(C)NC(=O)C(C(C)O)NC(=O)C(CC(=O)N)NC(=O)C(CS)NC(=O)C(CCCCN)N
    2.1.5 Isomeric SMILES
    CC[C@H](C)[C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N1CCC[C@H]1C(=O)N2CCC[C@H]2C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H](C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC3=CC=C(C=C3)O)C(=O)N)NC(=O)[C@@H]4CCCN4C(=O)CNC(=O)[C@H](CC5=CC=CC=C5)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H](CC6=CN=CN6)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC7=CC=CC=C7)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](C)NC(=O)[C@H](CS)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](C)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](CS)NC(=O)[C@H](CCCCN)N
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Ac 0137

    2. Ac 137

    3. Lys-cys-asn-thr-ala-thr-cys-ala-thr-gln-arg-leu-ala-asn-phe-leu-val-his-ser-ser-asn-asn-phe-gly-pro-ile-leu-pro-pro-thr-asn-val-gly-ser-asn-thr-tyr-nh2

    4. Pramlintide

    5. Pramlintide Acetate

    6. Tripro-amylin

    2.2.2 Depositor-Supplied Synonyms

    1. Pramlintide Acetate [usan]

    2. Schembl238214

    3. Unii-726i6te06g

    4. Aco137

    5. 726i6te06g

    6. 25-l-proline-28-l-proline-29-l-proline-, Acetate (salt), Hydrate

    7. 25-l-proline-28-l-proline-29-l-prolineamylin (human) Acetate (salt), Hydrate

    2.3 Create Date
    2007-07-03
    3 Chemical and Physical Properties
    Molecular Weight 3951 g/mol
    Molecular Formula C171H269N51O53S2
    XLogP3-16.7
    Hydrogen Bond Donor Count58
    Hydrogen Bond Acceptor Count59
    Rotatable Bond Count122
    Exact Mass3949.9396798 g/mol
    Monoisotopic Mass3948.9363250 g/mol
    Topological Polar Surface Area1690 Ų
    Heavy Atom Count277
    Formal Charge0
    Complexity9620
    Isotope Atom Count0
    Defined Atom Stereocenter Count41
    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 NameSymlin
    PubMed HealthPramlintide (Injection)
    Drug ClassesAntidiabetic
    Active IngredientPramlintide acetate
    Dosage FormInjectable
    RouteSubcutaneous
    Strengtheq 1.5mg base/1.5ml (eq 1mg base/ml); eq 2.7mg base/2.7ml (eq 1mg base/ml)
    Market StatusPrescription
    CompanyAstrazeneca Ab

    2 of 2  
    Drug NameSymlin
    PubMed HealthPramlintide (Injection)
    Drug ClassesAntidiabetic
    Active IngredientPramlintide acetate
    Dosage FormInjectable
    RouteSubcutaneous
    Strengtheq 1.5mg base/1.5ml (eq 1mg base/ml); eq 2.7mg base/2.7ml (eq 1mg base/ml)
    Market StatusPrescription
    CompanyAstrazeneca Ab

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Hypoglycemic Agents

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

    API SUPPLIERS

    read-more
    read-more

    01

    Bachem AG

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Nitrosamine Risks in Peptide APIs
    Hosting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

    Contact Supplier Contact Supplier
    Flag Switzerland
    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52416-106

    Start Marketing Date : 2005-05-16

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    Bachem company banner

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    Sun Pharmaceutical Industries Limi...

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PREP
    Not Confirmed
    arrow

    Sun Pharmaceutical Industries Limi...

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PREP
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-04-30

    Pay. Date : 2017-03-27

    DMF Number : 31548

    Submission : 2018-03-29

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    03

    Mallinckrodt Pharmaceuticals

    Ireland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PREP
    Not Confirmed
    arrow

    Mallinckrodt Pharmaceuticals

    Ireland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PREP
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12646

    Submission : 1997-09-05

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    04

    PolyPeptide Group

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PREP
    Not Confirmed
    arrow

    PolyPeptide Group

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PREP
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15096

    Submission : 2000-10-16

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    05

    Biopeptek Pharmaceuticals

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PREP
    Not Confirmed
    arrow

    Biopeptek Pharmaceuticals

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PREP
    Not Confirmed
    USDMF CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 73212-099

    Start Marketing Date : 2024-06-03

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    06

    Country

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PREP
    Not Confirmed
    arrow

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PREP
    Not Confirmed
    USDMF CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 85512-1178

    Start Marketing Date : 2025-06-02

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    07

    BCN Peptides

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PREP
    Not Confirmed
    arrow

    BCN Peptides

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    PREP
    Not Confirmed
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    08

    Teva Pharmaceutical Industries

    Israel

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PREP
    Not Confirmed
    arrow

    09

    ANHUI ANKE BIOTECHNOLOGY (GROUP) C...

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PREP
    Not Confirmed
    arrow

    10

    Shenzhen JYMed Technology

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    PREP
    Not Confirmed
    arrow
    Only 10 entries up to this point, click to access all click full view read-more
    click full view
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    DRUG PRODUCT COMPOSITIONS

    Do you need Business Intel? Ask us

    DOSAGE - INJECTABLE;SUBCUTANEOUS - EQ 1.5MG B...DOSAGE - INJECTABLE;SUBCUTANEOUS - EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)

    USFDA APPLICATION NUMBER - 21332

    read-more

    DOSAGE - INJECTABLE;SUBCUTANEOUS - EQ 2.7MG B...DOSAGE - INJECTABLE;SUBCUTANEOUS - EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)

    USFDA APPLICATION NUMBER - 21332

    read-more

    Related Excipient Companies

    Upload your portfolio for free, ask us

    Excipients by Applications

    Click here to find the perfect excipient manufacturers by their capabilities

    Fillers, Diluents & Binders

    read-more
    read-more

    Chewable & Orodispersible Aids

    read-more
    read-more

    Direct Compression

    read-more
    read-more

    Taste Masking

    read-more
    read-more

    Disintegrants & Superdisintegrants

    read-more
    read-more

    Parenteral

    read-more
    read-more

    Co-Processed Excipients

    read-more
    read-more

    Granulation

    read-more
    read-more

    Solubilizers

    read-more
    read-more

    Thickeners and Stabilizers

    read-more
    read-more

    Digital Content read-more

    Create Content with PharmaCompass, ask us

    DATA COMPILATION #PharmaFlow

    read-more
    read-more
    FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments

    FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments

    This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder).  Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period.  Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.  
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 4748

    https://www.pharmacompass.com/radio-compass-blog/fda-s-june-2024-list-of-off-patent-off-exclusivity-drugs-sees-rise-in-cancer-hiv-treatments

    #PharmaFlow by PHARMACOMPASS
    11 Jul 2024
    Share Share

    Global Sales Information

    Do you need Business Intel? Ask us

    Market Place

    Do you need sourcing support? Ask us

    REF. STANDARDS & IMPURITIES

    Upload your portfolio for free, ask us

    ABOUT THIS PAGE

    Looking for / Pramlintide API manufacturers, exporters & distributors?

    Pramlintide manufacturers, exporters & distributors 1

    31

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

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

    PharmaCompass also assists you with knowing the Pramlintide API Price utilized in the formulation of products. Pramlintide API Price is not always fixed or binding as the Pramlintide Price is obtained through a variety of data sources. The Pramlintide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Pramlintide

    Synonyms

    Pramlintide acetate [usan], Schembl238214, Unii-726i6te06g, Aco137, 726i6te06g, 25-l-proline-28-l-proline-29-l-proline-, acetate (salt), hydrate

    About Pramlintide

    Pramlintide Acetate is the acetate salt form of pramlintide, a peptide analogue of human amylin with 3 proline substitutions at position 25, 28 and 29, with antihyperglycemic activity. By mimicking amylin, pramlintide slows gastric emptying, inhibits digestive secretions (gastric acid, pancreatic enzymes, and bile), reduces glucagon secretion, and increases satiety; all of these actions are mediated mostly by glucose-sensitive areas in the brain stem. The overall result is a decrease in blood glucose levels. The use of pramlintide may cause an increased risk of insulin-induced hypoglycemia.

    Pramlintide Manufacturers

    A Pramlintide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pramlintide, including repackagers and relabelers. The FDA regulates Pramlintide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pramlintide 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 Pramlintide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Pramlintide Suppliers

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

    click here to find a list of Pramlintide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Pramlintide USDMF

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

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

    click here to find a list of Pramlintide suppliers with USDMF on PharmaCompass.

    Pramlintide 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 Pramlintide as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Pramlintide 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 Pramlintide 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 Pramlintide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pramlintide NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Pramlintide suppliers with NDC on PharmaCompass.

    Pramlintide GMP

    Pramlintide 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 Pramlintide 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 Pramlintide GMP manufacturer or Pramlintide GMP API supplier for your needs.

    Pramlintide CoA

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

    Pramlintide CoA mostly includes findings from lab analyses of a specific batch. For each Pramlintide 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.

    Pramlintide may be tested according to a variety of international standards, such as European Pharmacopoeia (Pramlintide EP), Pramlintide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pramlintide 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.
    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search