menu
    • menu

    Find Elagolix Sodium manufacturers, exporters & distributors on PharmaCompass

    Client Email Product
    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

    Virtual Booth

    Contact Supplier

    Bora Pharmaceuticals- Making success more certain.

    Virtual Booth

    Contact Supplier

    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

    Virtual Booth

    Contact Supplier

    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    Virtual Booth

    Contact Supplier

    Axplora- The partner of choice for complex APIs.

    Virtual Booth

    Contact Supplier

    Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

    Virtual Booth

    Contact Supplier

    ACTIVE PHARMA INGREDIENTS

    INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS & EXCLUSIVITIES

    PharmaCompass

    Synopsis

    Product SearchProduct Search

    Synopsis

    ACTIVE PHARMA INGREDIENTS

    43

    API Suppliers

    API Suppliers

    20

    USDMF

    US DMFs Filed

    0

    CEP/COS

    CEP/COS Certifications

    0

    JDMF

    JDMFs Filed

    1

    EU WC

    EU WC

    0

    KDMF

    KDMF

    12

    NDC API

    NDC API

    0

    VMF

    NDC API

    31

    Listed Suppliers

    Other Suppliers

    API REF. PRICE (USD/KG)

    $
    $ 6,337

    MARKET PLACE

    5

    API

    0

    FDF

    7INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    5

    FDF Dossiers

    FDF Dossiers

    3

    FDA Orange Book

    FDA (Orange Book)

    0

    Europe

    Europe

    2

    Canada

    Canada

    0

    Australia

    Australia

    0

    South Africa

    South Africa

    0

    Listed Dossiers

    Listed Dossiers

    0 DRUGS IN DEVELOPMENT

    FDF Dossiers

    DRUG PRODUCT COMPOSITIONS

    REF. STANDARDS OR IMPURITIES

    0

    EDQM

    0

    USP

    0

    JP

    0

    Others

    PATENTS & EXCLUSIVITIES

    23

    US Patents

    0

    US Exclusivities

    0

    Health Canada Patents

    DIGITAL CONTENT

    5

    Data Compilation #PharmaFlow

    0

    Stock Recap #PipelineProspector

    0

    Weekly News Recap #Phispers

    30

    News #PharmaBuzz

    GLOBAL SALES INFORMATION

    US Medicaid

    3,696,413

    Annual Reports

    363

    Finished Drug Prices

    NA

    0RELATED EXCIPIENT COMPANIES

    0EXCIPIENTS BY APPLICATIONS

    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: Elagolix sodium salt, 832720-36-2, Orlissa, Elagolix sodium [usan], Nbi-56418 na, Nbi-56418-na
    Molecular Formula
    C32H29F5N3NaO5
    Molecular Weight
    653.6  g/mol
    InChI Key
    DQYGXRQUFSRDCH-UQIIZPHYSA-M
    FDA UNII
    5948VUI423
    Elagolix Sodium
    1 2D Structure

    Elagolix Sodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;4-[[(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-4-methyl-2,6-dioxopyrimidin-1-yl]-1-phenylethyl]amino]butanoate
    2.1.2 InChI
    InChI=1S/C32H30F5N3O5.Na/c1-19-28(21-11-6-14-26(45-2)29(21)34)30(43)40(18-25(20-9-4-3-5-10-20)38-16-8-15-27(41)42)31(44)39(19)17-22-23(32(35,36)37)12-7-13-24(22)33;/h3-7,9-14,25,38H,8,15-18H2,1-2H3,(H,41,42);/q;+1/p-1/t25-;/m0./s1
    2.1.3 InChI Key
    DQYGXRQUFSRDCH-UQIIZPHYSA-M
    2.1.4 Canonical SMILES
    CC1=C(C(=O)N(C(=O)N1CC2=C(C=CC=C2F)C(F)(F)F)CC(C3=CC=CC=C3)NCCCC(=O)[O-])C4=C(C(=CC=C4)OC)F.[Na+]
    2.1.5 Isomeric SMILES
    CC1=C(C(=O)N(C(=O)N1CC2=C(C=CC=C2F)C(F)(F)F)C[C@@H](C3=CC=CC=C3)NCCCC(=O)[O-])C4=C(C(=CC=C4)OC)F.[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    5948VUI423
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Elagolix

    2. Orilissa

    3. R-(+)-4-(2-(5-(2-fluoro-3-methoxyphenyl)-3-(2-fluoro-6-(trifluoromethyl)benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2h-pyrimidin-1-yl)-1-phenylethylamino)butyrate

    2.3.2 Depositor-Supplied Synonyms

    1. Elagolix Sodium Salt

    2. 832720-36-2

    3. Orlissa

    4. Elagolix Sodium [usan]

    5. Nbi-56418 Na

    6. Nbi-56418-na

    7. 832720-36-2 (sodium)

    8. 5948vui423

    9. Elagolix Sodium (usan)

    10. Sodium (r)-4-((2-(5-(2-fluoro-3-methoxyphenyl)-3-(2-fluoro-6-(trifluoromethyl)benzyl)-4-methyl-2,6-dioxo-2,3-dihydropyrimidin-1(6h)-yl)-1-phenylethyl)amino)butanoate

    11. Chembl502182

    12. Sodium;4-[[(1r)-2-[5-(2-fluoro-3-methoxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-4-methyl-2,6-dioxopyrimidin-1-yl]-1-phenylethyl]amino]butanoate

    13. Unii-5948vui423

    14. Nbi56418 Na

    15. Orilissa (tn)

    16. C32h29f5n3o5.na

    17. Schembl1641994

    18. Elagolix Sodium [who-dd]

    19. Elagolix Sodium Salt [mi]

    20. Dtxsid601003247

    21. Ex-a2388

    22. Mfcd12546649

    23. Elagolix Sodium [orange Book]

    24. Akos030524154

    25. Nbi56418; Abt-620

    26. Ccg-270333

    27. Oriahnn Component Elagolix Sodium

    28. Ac-29671

    29. As-56299

    30. Be163657

    31. Hy-14369

    32. Elagolix Sodium Component Of Oriahnn

    33. Cs-0003317

    34. D09336

    35. Q27261650

    36. 4-((r)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2h-pyrimidin-1-yl]-1-phenyl-ethylamino)-butyric Acid Sodium Salt

    37. Butanoic Acid, 4-(((1r)-2-(5-(2-fluoro-3-methoxyphenyl)-3-((2-fluoro-6-(trifluoromethyl)phenyl)methyl)-3,6-dihydro-4-methyl-2,6-dioxo-1(2h)-pyrimidinyl)-1- Phenylethyl)amino)-, Monosodium Salt

    38. Butanoic Acid, 4-(((1r)-2-(5-(2-fluoro-3-methoxyphenyl)-3-((2-fluoro-6-(trifluoromethyl)phenyl)methyl)-3,6-dihydro-4-methyl-2,6-dioxo-1(2h)-pyrimidinyl)-1-phenylethyl)amino)-, Monosodium Salt

    39. Sodium 4-(((1r)-2-(5-(2-fluoro-3-methoxyphenyl)-3-((2-fluoro-6- (trifluoromethyl)phenyl)methyl)-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2h)-yl)-1- Phenylethyl)amino)butanoate

    40. Sodium 4-(((1r)-2-(5-(2-fluoro-3-methoxyphenyl)-3-((2-fluoro-6-(trifluoromethyl)phenyl)methyl)-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2h)-yl)-1-phenylethyl)amino)butanoate

    2.4 Create Date
    2008-05-19
    3 Chemical and Physical Properties
    Molecular Weight 653.6 g/mol
    Molecular Formula C32H29F5N3NaO5
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count11
    Rotatable Bond Count12
    Exact Mass653.19250613 g/mol
    Monoisotopic Mass653.19250613 g/mol
    Topological Polar Surface Area102 Ų
    Heavy Atom Count46
    Formal Charge0
    Complexity1090
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 1  
    Drug NameORILISSA
    Active IngredientELAGOLIX SODIUM
    CompanyABBVIE INC (Application Number: N210450. Patents: 6872728, 7056927, 7176211, 7179815, 7419983, 7462625)

    API Reference Price

    read-more
    read-more
    [{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1634063400,"product":"ELAGOLIX SODIUM (TAX INVOICE NO:59102151","address":"1ST FLOOR,PLOT NO.497,VIVEKANANDANAGAR COLONY, KUKATPALLY","city":"HYDERABAD","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"GULF AGENCY COMPANY ","customerCountry":"UNITED ARAB EMIRATES","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"14850","totalValueFC":"14550.4","currency":"USD","unitRateINR":1090000,"date":"13-Oct-2021","totalValueINR":"1090000","totalValueInUsd":"14550.4","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"5270006","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"1ST FLOOR,PLOT NO.497,VIVEKANANDANAGAR COLONY, KUKATPALLY, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649356200,"product":"ELAGOLIX SODIUM (TAX INV NO:BPVCI\/22-23","address":"PLOT NO 92, 1-98\/2\/92,KAVURI HILLS - PHASE II,","city":"JUBILEE HILLS,TELANGANA","supplier":"BIOPHORE INDIA PHARMACEUTICALS PVT LTD","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"BILIM PHARMACEUTICALS","customerCountry":"TURKEY","quantity":"0.75","actualQuantity":"0.75","unit":"KGS","unitRateFc":"7500","totalValueFC":"5500.4","currency":"USD","unitRateINR":553333.33333333337,"date":"08-Apr-2022","totalValueINR":"415000","totalValueInUsd":"5500.4","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"9564778","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"PLOT NO 92, 1-98\/2\/92,KAVURI HILLS - PHASE II,, JUBILEE HILLS,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700677800,"product":"ELAGOLIX SODIUM NN (EXPORT INVOICE NO:6123010440 DT:22.11.2023)","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"LEE PHARMA","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"COMMERCIAL BANK OF ","customerCountry":"BANGLADESH","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"2500","totalValueFC":"2413.8","currency":"USD","unitRateINR":201000,"date":"23-Nov-2023","totalValueINR":"201000","totalValueInUsd":"2413.8","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"5535496","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SYNO.257 258\/1, DNO.11-6\/56,, VILLAGE BALANGAR POST HYDERABAD","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1625596200,"product":"ELAGOLIX SODIUM","address":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3","city":"","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"SINGAPORE","customer":"SYNGENE INTERNATIONAL LIMITED","customerCountry":"INDIA","quantity":"92.00","actualQuantity":"92","unit":"KGS","unitRateFc":"6800","totalValueFC":"632090.9","currency":"USD","unitRateINR":"512040","date":"07-Jul-2021","totalValueINR":"47107680","totalValueInUsd":"632090.9","indian_port":"Biocon-SEZ","hs_no":"29420090","bill_no":"1009383","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"SINGAPORE","supplierAddress":"36 HOPING STREET, LOUCHU COUNTY TAOYUAN TAIWAN-33842 0 0","customerAddress":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1632940200,"product":"ELAGOLIX SODIUM","address":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3","city":"","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"TAOYUAN","customer":"SYNGENE INTERNATIONAL LIMITED","customerCountry":"INDIA","quantity":"11.00","actualQuantity":"11","unit":"KGS","unitRateFc":"6800","totalValueFC":"75657.8","currency":"USD","unitRateINR":"505920","date":"30-Sep-2021","totalValueINR":"5565120","totalValueInUsd":"75657.8","indian_port":"Biocon-SEZ","hs_no":"29339990","bill_no":"1014147","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAOYUAN","supplierAddress":"NO.36 HOPING STREET LOUCHU TAOYUAN 33842 Taiwan","customerAddress":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1633026600,"product":"ELAGOLIX SODIUM (TEST LIC NO.TL\/BDZ\/21\/000217 DT:15\/09\/2021)","address":"ALKEM HOUSE, DEVASHISH ADJACENT T O,MATULYA CENTRE, SENAPATI BAPAT MA","city":"MUMBAI,MAHARASHTRA","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"67.53","actualQuantity":"67.526","unit":"KGS","unitRateFc":"5500","totalValueFC":"368854.8","currency":"USD","unitRateINR":"409200","date":"01-Oct-2021","totalValueINR":"27631639.2","totalValueInUsd":"368854.8","indian_port":"DELHI AIR","hs_no":"29339990","bill_no":"5659510","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT T O,MATULYA CENTRE, SENAPATI BAPAT MA"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1633026600,"product":"ELAGOLIX SODIUM (TEST LIC NO.TL\/BDZ\/21\/000217 DT:15\/09\/2021)","address":"ALKEM HOUSE, DEVASHISH ADJACENT T O,MATULYA CENTRE, SENAPATI BAPAT MA","city":"MUMBAI,MAHARASHTRA","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"ALKEM LABORATORIES","customerCountry":"INDIA","quantity":"78.21","actualQuantity":"78.206","unit":"KGS","unitRateFc":"5500","totalValueFC":"427193.3","currency":"USD","unitRateINR":"409200","date":"01-Oct-2021","totalValueINR":"32001895.2","totalValueInUsd":"427193.3","indian_port":"DELHI AIR","hs_no":"29339990","bill_no":"5659510","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALKEM HOUSE, DEVASHISH ADJACENT T O,MATULYA CENTRE, SENAPATI BAPAT MA"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1636482600,"product":"ELAGOLIX SODIUM (SAMPLES FOR R&D PURPOSES ONLY)","address":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI","city":"GARDEN CITY OFF WESTERN EXPR HIGHWA","supplier":"PLUSCHEM","supplierCountry":"SWITZERLAND","foreign_port":"NA","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"0.18","actualQuantity":"0.175","unit":"KGS","unitRateFc":"5700","totalValueFC":"1214.3","currency":"USD","unitRateINR":"516762","date":"10-Nov-2021","totalValueINR":"90433.35","totalValueInUsd":"1214.3","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"6197851","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1636482600,"product":"ELAGOLIX SODIUM (SAMPLES FOR R&D PURPOSES ONLY)","address":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI","city":"GARDEN CITY OFF WESTERN EXPR HIGHWA","supplier":"PLUSCHEM","supplierCountry":"SWITZERLAND","foreign_port":"NA","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"0.48","actualQuantity":"0.475","unit":"KGS","unitRateFc":"5700","totalValueFC":"3296.1","currency":"USD","unitRateINR":"516762","date":"10-Nov-2021","totalValueINR":"245461.95","totalValueInUsd":"3296.1","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"6197851","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1673202600,"product":"ELAGOLIX SODIUM","address":"INSPIRE BKC PART OF 601 AND 701,BA NDRAKURLA COMPLEX BANDRA EAST","city":"MUMBAI,MAHARASHTRA","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"NOVARTIS PHARMACEUTICALS CORPORATION","customerCountry":"INDIA","quantity":"24.00","actualQuantity":"24","unit":"KGS","unitRateFc":"6800","totalValueFC":"167073.5","currency":"USD","unitRateINR":"569160","date":"09-Jan-2023","totalValueINR":"13659840","totalValueInUsd":"167073.5","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"4105524","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"INSPIRE BKC PART OF 601 AND 701,BA NDRAKURLA COMPLEX BANDRA EAST"}]
    07-Jul-2021
    23-Nov-2023
    KGS
    overview
    Loading...

    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

    Upgrade, download data, analyse, strategize, subscribe with us contact

    Digital Content read-more

    Create Content with PharmaCompass, ask us

    DATA COMPILATION #PharmaFlow

    read-more
    read-more
    DMF submissions rise 12.1% in 2022; India sees 10.6% drop in Type II filings

    DMF submissions rise 12.1% in 2022; India sees 10.6% drop in Type II filings

    In 2022, the world finally began to emerge out of Covid-related restrictions. Though 2020 and 2021 saw several travel-related curbs, there was no let up in the speed at which generic active pharmaceutical ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug Administration (FDA). In the four years between 2018 and 2021, the number of Type II DMF submissions (i.e. submissions for drug substance, drug substance intermediate, and material used in their preparation, or drug product) remained steady at over 630 per year.In 2022, the DMF submissions rose at an impressive pace of 12.1 percent. A total of 1,024 DMFs (Types II, III, IV and V) were submitted in 2022, as opposed to 913 in 2021.Last year, Type II DMF submissions increased by 7.2 percent — a total of 715 Type II DMFs were submitted in 2022 as opposed to 667 in 2021. However, of the 715 DMFs filed with the FDA, only 190 (26 percent) had their reviews completed.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available) DMF submissions from India dip 10.6%, China’s filings increase 45%As always, DMFs filed from India and China were significantly higher than DMFs from other countries. However, the year saw DMF submissions from India drop by 10.6 percent. Overall DMF submission from India stood at 336, as opposed to 376 in 2021. In comparison, China’s DMF filings increased by 45 percent to 231 in 2022, as opposed to 159 in 2021. Interestingly, FDA had issued 31 Form 483s in 2022 out of which 15 were issued to Indian drugmakers. Out of 15, seven Form 483s were issued to manufacturing units belonging to four Indian API manufacturers — Lupin, Aurobindo Pharma, Torrent and Biocon Biologics.While DMFs are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products, a Form 483 is a notification sent by the FDA to a drugmaker regarding objectionable conditions at a facility. A Form 483 is issued at the conclusion of an inspection, when an investigator finds regulatory violations and/or non-compliance of good manufacturing practices. January 2023 saw a spate of Form 483s issued to Indian drugmakers, raising concerns within the pharma industry.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available)   India’s Metrochem API tops DMF submissionsIndia’s Metrochem API led the list of companies with the highest number of DMF submissions at 19. MSN Labs stood second with 16 submissions.Other top Indian companies were Aurobindo Pharma (15), Biophore India (15), Hetero Group (11) and Cipla (10), followed by two Chinese companies — BrightGene Bio-Medical Technology and Changzhou Pharmaceutical Factory — with 9 submissions each.The maximum number of DMF filings were for elagolix sodium (11), empagliflozin (eight), tofacitinib citrate (six), revefenacin (six), apixaban (five), brivaracetam (five), cannabidiol (five), followed by mirabegron (five) and tafamidis (five).A total of 79 DMFs were filed for the first time for 64 products, of which 28 had their GDUFA  (Generic Drug User Fee Amendments) review completed. These include revefenacin (six), migalastat hydrochloride (three), cupric sulfate (three), ivosidenib (two), upadacitinib (one) and voxelotor (one). Revefenacin is losing its marketing exclusivity this year.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available)   Our viewIn our last (H1 2022) review of DMF submissions, we had mentioned that less than half of the 350 Type II DMFs filed by the FDA had been reviewed, as the user fee program had not been reauthorized.FDA published the New GDUFA III fee structure at the eleventh hour — on September 30, 2022. GDUFA III includes several enhancements to the abbreviated new drug application (ANDA) assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality and affordable generics.With the GDUFA III, the US government has made clear its intent to lower generic drug prices. In future, more drugs are likely to go off-patent and we are likely to see the number of DMF submissions rise even further.In the second quarter of 2022, FDA resumed unannounced inspections in India. The regulator has also stepped up onsite inspections. FDA wants cheaper drugs, but not at the cost of quality. There are no short-cuts for generic and bulk drug manufacturers wanting to export to the US.(This article has been updated to accurately reflect the information on Metrochem API and MSN Labs.) 
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 2382

    https://www.pharmacompass.com/radio-compass-blog/dmf-submissions-rise-12-1-in-2022-india-sees-10-6-drop-in-type-ii-filings

    #PharmaFlow by PHARMACOMPASS
    02 Feb 2023
    Share Share

    NEWS #PharmaBuzz

    read-more
    read-more

    Global Sales Information

    Do you need Business Intel? Ask us

    Market Place

    Do you need sourcing support? Ask us

    Patents & EXCLUSIVITIES

    Check the patents & exclusivity for this product

    ABOUT THIS PAGE

    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