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    Company profile for MSN Laboratories

    SPI Pharma has been solving formulation challenges using superior functional materials.

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    About

    Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderaba...
    Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs

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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    Alchem NicSelect™ grants customers royalty-free access to T-MAX™ tech for 3-in-1 vape satisfaction in flavour-restricted markets

    micAlchem NicSelect™ grants customers royalty-free access to T-MAX™ tech for 3-in-1 vape satisfaction in flavour-restricted markets

    With increasing flavour bans in key markets, vaping brands are facing significant challenges in providing satisfying alternatives to vapers and smokers looking to transition. Recognising this need, Alchem NicSelect™ is making a bold move by offering its key customers royalty-free and unrestricted geographical access to its revolutionary T-MAX™ technology.“At Alchem NicSelect™, we understand the urgency for vaping brands to adapt to new regulations without compromising on satisfaction. By offering royalty-free access to T-MAX™ technology, we empower our customers to provide the closest cigarette-like experience possible, even in markets with strict flavour restrictions,” said Riccardo Santambrogio, Europe Sales Manager.HIGHLIGHTS// offering royalty-free access to T-MAX™ technology/ unrestricted geographical access/ closest cigarette-like experience Addressing the biggest barrier: Nicotine satisfactionOne of the primary reasons many vapers are dissatisfied and smokers struggle to switch to vaping is that traditional nicotine solutions fail to replicate the rapid satisfaction provided by cigarettes. Nicotine replacement therapies (NRTs) and even conventional vaping products often lack the immediate nicotine hit, throat feel, and overall experience that smokers are accustomed to. T-MAX™ solves this problem by engineering a nicotine experience that closely mimics cigarette consumption without relying on flavours.T-MAX™ provides a unique 3-in-1 approach:1. The Speed of a Cigarette – Rapid nicotine delivery and rush within seconds for immediate satisfaction.2. The Power of Nicotine Salts – A stronger perceived nicotine effect without exceeding legal limits (20 mg/ml nicotine limit under the European Tobacco Products Directive). With T-MAX™, 8 mg/ml feels like 20 mg/ml, and 14 mg/ml feels like 40 mg/ml.3. The Throat Hit of Freebase Nicotine – Especially in a flavour-free formulation, the combined ingredients in T-MAX™ deliver an even more satisfying throat feel than expected from nicotine base, much closer to and more familiar with a cigarette throat feel that habitual smokers recognise.HIGHLIGHTS// unique 3-in-1 approach/ rush within seconds/ stronger perceived nicotine effect without exceeding legal limits/ more satisfying throat feel that habitual smokers recogniseNo flavour, but not less satisfyingWhile flavours have traditionally played a role in vaping adoption, market realities are shifting. With flavour bans spreading across regions, brands need solutions that deliver satisfaction without relying on taste. Consumer research has shown that T-MAX™ performs exceptionally well even without added flavours. Since most cigarette smokers do not smoke for the tobacco flavour but rather for the nicotine hit and habitual experience, T-MAX™ provides a viable alternative that aligns with new regulatory landscapes.HIGHLIGHTS// flavour bans spreading across regions/ T-MAX™ performs exceptionally well even without added flavoursEmpowering vape brands with free access to T-MAX™By granting customers royalty-free access to the T-MAX™ technology, Alchem NicSelect™ is removing barriers for vaping brands and original equipment manufacturers (OEMs) looking to adapt to regulatory changes. This open-access approach ensures that manufacturers can integrate T-MAX™ into their product lines without additional costs, allowing them to offer superior nicotine satisfaction in markets where flavours are no longer an option.HIGHLIGHTS// removing barriers for vaping brands and OEMs looking to adapt/ manufacturers can integrate T-MAX™ into product lines without additional costsThe future of vaping in restricted marketsWith T-MAX™, the vaping industry has a powerful tool to retain customers and convert smokers who have struggled with traditional vaping products. By delivering the key elements of cigarette satisfaction — without combustion or flavours — T-MAX™ is set to redefine what a satisfying vape experience means in a post-flavour-ban world.“Our commitment to innovation and accessibility means we are providing our customers with the solutions they need to navigate an evolving regulatory landscape. T-MAX™ allows brands to offer a highly satisfying experience that mimics smoking without relying on flavours. The message is clear: no flavour, but not less satisfying”, added Santambrogio.HIGHLIGHTS// powerful tool to retain customers and convert smokers/ delivering the key elements of cigarette satisfaction without combustion or flavours/ no flavour, but not less satisfying

    Impressions: 274

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    https://www.pharmacompass.com/speak-pharma/alchem-nicselect-grants-customers-royalty-free-access-to-t-max-tech-for-3-in-1-vape-satisfaction-in-flavour-restricted-markets

    Radio Compass
    06 May 2025
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    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaConnecting People, Mentalities & MarketsConnecting People, Mentalities & Markets

    Connecting People, Mentalities & Markets
    Connecting People, Mentalities & Markets

    reelConnecting People, Mentalities & Markets

    This PharmaReel highlights Transo-Pharm USA’s offerings of premium Phyto Cannabidiol (CBD) and Phyto Cannabigerol (CBG) isolates from its cGMP-certified facility inspected by the FDA and ANVISA. The company has an expanded reach across the US and EU.

    Impressions: 332

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    DMF filings surge 44% in Q1 2025; India tops list with 51% rise in year-on-year submissions

    DMF filings surge 44% in Q1 2025; India tops list with 51% rise in year-on-year submissions

    The first quarter (Q1) of 2025 witnessed an impressive surge in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA), signaling a robust expansion in pharmaceutical development activities, the looming threat of tariffs notwithstanding.A total of 339 Type II DMFs were submitted during this period, as opposed to 235 submissions in Q1 2024, marking an exceptional increase of 44.26 percent. PharmaCompass’ data suggests that this is a record high for any first quarter.Overall, 440 DMFs were submitted across all categories (Types II, III, IV, and V) during Q1 2025, compared to 353 in the same period last year — representing a 24.65 percent increase.India and China continued to dominate the DMF landscape. India led with 162 submissions in Q1 2025, posting a remarkable 51.4 percent increase over 107 submissions recorded in Q1 2024. China followed with 135 submissions, representing a 33.66 percent increase over the 101 filings in Q1 2024.Taiwan sprung a surprise as a distant third. It made 12 DMF submissions in Q1 2025, as opposed to just one in Q1 2024. Western countries like the US, Spain, Germany, and Italy have maintained relatively stable or declining submission rates. Only the Netherlands showed significant growth with four DMF submissions in Q1 2025, up from zero in Q1 2024. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available)Indian giants MSN, Aurobindo, Cipla, Dr Reddy’s lead record-breaking DMF surgeIndia lived up to its “pharmacy of the world” reputation with the highest DMF submissions. In fact, seven of the top eight companies in the DMF tally were headquartered in India. MSN Group, emerged as the unequivocal leader with 23 submissions in Q1 2025, as against 15 in Q1 2024. Aurobindo Pharma increased its DMF activity from seven submissions in Q1 2024 to 12 in Q1 2025. Alivus Life Sciences, formerly known as Glenmark, made a dramatic leap with eight submissions in Q1 2025, quadrupling its previous year’s count of just two. Cipla more than doubled its DMF submissions — from three in Q1 2024 to eight in Q1 2025.Dr. Reddy’s Laboratories, one of India’s largest generic drugmakers, filed seven DMF submissions. The company’s Q1 2025 DMF portfolio includes high-value molecules like deucravacitinib, finerenone, enzalutamide, niraparib tosylate monohydrate, tucatinib, and tizanidine hydrochloride.Dr. Reddy’s has also indicated that they are open to manufacturing in the US. Meanwhile, Hetero Drugs filed seven submissions while Lee Pharma recorded six in Q1 2025.Chinese manufacturer Jiangsu East-Mab Biomedical Technology also established a significant presence with six DMFs. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Semaglutide, finerenone see most DMF submissions; first-time filings surge 64%Semaglutide and finerenone emerged as the most documented molecules in Q1 2025, each garnering nine DMF submissions. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist that has revolutionized diabetes management and weight loss treatment, continues to attract significant manufacturer interest. Similarly, finerenone, a non-steroidal drug used in treating chronic kidney disease in type 2 diabetes patients, has garnered attention from manufacturers.Carfilzomib, used in multiple myeloma treatment, secured the third position with five DMF submissions. Deucravacitinib, a novel drug approved for moderate to severe plaque psoriasis, followed with four DMF submissions.There were several molecules with three DMF submissions each. Among them were tapinarof, a novel drug for psoriasis, and tirzepatide, a GLP-1/GIP receptor agonist that has shown remarkable efficacy in diabetes and weight management. During the quarter, 23 molecules received their inaugural DMF submissions. This number has risen by 64 percent since Q1 2024, when only 14 drugs saw their first DMF filings.In Q1 2025, these 23 first-time molecules collectively garnered 30 DMF submissions, with deucravacitinib emerging as the clear leader. Indian companies Dr. Reddy’s Laboratories and Cipla filed DMFs for this plaque psoriasis treatment as did Spain’s Curia and PMC Global.The Q1 2025 roster of first-time DMF filings include retatrutide (another GLP-1 receptor agonist), sotagliflozin, setmelanotide acetate, daridorexant, nusinersen, zavegepant, belzutifan, elacestrant dihydrochloride, selumetinib sulfate, sotorasib, atogepant, omadacycline tosylate, osilodrostat phosphate, ensifentrine, landiolol hydrochloride, maralixibat chloride, maribavir, methyl olivetolate, diazoxide choline, sparsentan, thinnertide, and vismodegib. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Our viewGiven Trump’s rhetoric around tariffs on imported drugs, the record-breaking DMF submissions in Q1 2025 sent out a strong message that the global pharmaceutical industry is willing to take on the complex geopolitical situation with resilience and strategic foresight.On a different note, the rise in DMF filings also indicate increased workload for the FDA staff, as also more inspections by the agency. It seems like more ‘laid off’ FDA employees will be asked to return to work in the coming days.
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    Impressions: 519

    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-surge-44-in-q1-2025-india-tops-list-with-51-rise-in-year-on-year-submissions

    #PharmaFlow by PHARMACOMPASS
    15 May 2025
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    NEWS #PharmaBuzz

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    Pharma Companies Rush to Develop Weight-loss Drug Semaglutide
    Pharma Companies Rush to Develop Weight-loss Drug Semaglutide

    12 Apr 2025

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/weight-is-over-pharma-companies-race-to-make-weight-loss-drug-semaglutide/articleshow/120215666.cms

    ECONOMICTIMES
    12 Apr 2025
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    MSN`s Generics Lofexidine HCl Receives Approval in US
    MSN`s Generics Lofexidine HCl Receives Approval in US

    24 Feb 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218699

    FDA
    24 Feb 2025
    Share Share
    MSN`s Generics Posaconazole Receives Approval in US
    MSN`s Generics Posaconazole Receives Approval in US

    24 Feb 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218434

    FDA
    24 Feb 2025
    Share Share
    MSN Lab`s Generics Perampanel Receive Tentative Approval in US
    MSN Lab`s Generics Perampanel Receive Tentative Approval in US

    08 Jan 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218178

    FDA
    08 Jan 2025
    Share Share
    MSN Lab`s Generics Perampanel Receives Tentative Approval in US
    MSN Lab`s Generics Perampanel Receives Tentative Approval in US

    16 Dec 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218152

    FDA
    16 Dec 2024
    Share Share
    BeiGene defends Brukinsa from MSN's generic threat until 2037
    BeiGene defends Brukinsa from MSN's generic threat until 2037

    19 Nov 2024

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/patent-settlement-beigene-defends-brukinsa-msns-generic-threat-until-2037

    FIERCE PHARMA
    19 Nov 2024
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    ALL APIs

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    01

    Duloxetine Hydrochloride

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

    American Thoracic Society
    Not Confirmed
    arrow

    Duloxetine Hydrochloride

    India

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

    arrow
    American Thoracic Society
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-11-17

    Pay. Date : 2020-11-10

    DMF Number : 20996

    Submission : 2007-10-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-368 - Rev 01

    Issue Date : 2024-07-03

    Type : Chemical

    Substance Number : 2594

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10088

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.

    Initial Date of Registration : 2017-04-26

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0021n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 14501-0005

    Start Marketing Date : 2010-03-24

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2012-04-13

    Registration Number : Su342-8-ND

    Manufacturer Name : MSN Laboratories PVT LTD

    Manufacturer Address : Sy. No. 317 , 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), Sangareddy District, Pincode-502 329, Telangana, India

     VMF Others AUDIT
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    02

    Dutasteride

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

    American Thoracic Society
    Not Confirmed
    arrow

    Dutasteride

    India

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

    arrow
    American Thoracic Society
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-09

    Pay. Date : 2012-12-06

    DMF Number : 23533

    Submission : 2010-02-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-019 - Rev 01

    Issue Date : 2024-12-16

    Type : Chemical

    Substance Number : 2641

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10024

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.

    Initial Date of Registration : 2018-02-14

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0021n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 14501-0006

    Start Marketing Date : 2010-03-24

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : 아이엠씨디코리아주식회사

    Registration Date : 2020-08-20

    Registration Number : No. 173-26-ND(2)

    Manufacturer Name : MSN Laboratories Private Limited

    Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), Sangareddy District, Pin code : 502 329, Telangana, India.

     VMF Others AUDIT
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    03

    Lacosamide

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

    American Thoracic Society
    Not Confirmed
    arrow

    Lacosamide

    India

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

    arrow
    American Thoracic Society
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-04

    Pay. Date : 2012-11-20

    DMF Number : 26270

    Submission : 2012-07-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-060 - Rev 04

    Issue Date : 2024-07-19

    Type : Chemical

    Substance Number : 2992

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10101

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.

    Initial Date of Registration : 2024-07-17

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2019-08-16

    Valid Till : 2025-08-15

    Written Confirmation Number : WC-0022

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 50370-0024

    Start Marketing Date : 2011-12-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2016-03-25

    Registration Number : No. 4749-16-ND(1)

    Manufacturer Name : MSN Pharmachem Private Limited

    Manufacturer Address : Plot No.: 182 to 186 ,192-A, 193 to 197 & 212/ A,B,C,D, Phase-II, IDA Pashamylaram, Pashamylararn (Village), Patancheru (Mandal), Sangareddy District, Telangana, Pin code: 502 307, India.

     VMF Others AUDIT
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    04

    Oseltamivir Phosphate

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

    American Thoracic Society
    Not Confirmed
    arrow

    Oseltamivir Phosphate

    India

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

    arrow
    American Thoracic Society
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-05-16

    Pay. Date : 2014-04-25

    DMF Number : 23889

    Submission : 2010-06-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-067 - Rev 02

    Issue Date : 2023-10-24

    Type : Chemical

    Substance Number : 2422

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10042

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.

    Initial Date of Registration : 2017-02-15

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2019-08-16

    Valid Till : 2025-08-15

    Written Confirmation Number : WC-0022

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 69766-092

    Start Marketing Date : 2020-12-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2019-08-06

    Registration Number : 20180308-209-J-187(2)

    Manufacturer Name : MSN Pharmachem Private Limited

    Manufacturer Address : Plot No. 212/ A,B,C,D, Phase-II, IDA Pashamylaram, Pashamylaram (Village), Patancheru (Mandal), Sangareddy District, 502 307, Telangana India.

     VMF Others AUDIT
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    05

    Voriconazole

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

    American Thoracic Society
    Not Confirmed
    arrow

    Voriconazole

    India

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

    arrow
    American Thoracic Society
    Not Confirmed
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    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-21

    Pay. Date : 2013-09-11

    DMF Number : 21523

    Submission : 2008-04-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2011-387 - Rev 01

    Issue Date : 2023-06-29

    Type : Chemical

    Substance Number : 2576

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10097

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.

    Initial Date of Registration : 2018-08-02

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0021n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 70600-045

    Start Marketing Date : 2023-03-15

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Pioglitazone Hydrochloride

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

    American Thoracic Society
    Not Confirmed
    arrow

    Pioglitazone Hydrochloride

    India

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

    arrow
    American Thoracic Society
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-17

    Pay. Date : 2017-02-27

    DMF Number : 24181

    Submission : 2010-09-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-005 - Rev 00

    Issue Date : 2019-02-20

    Type : Chemical

    Substance Number : 2601

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10024

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.

    Initial Date of Registration : 2019-06-28

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2020-04-15

    Valid Till : 2023-05-19

    Written Confirmation Number : WC-0281new2

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 50379-0008

    Start Marketing Date : 2012-07-03

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : (주)에스지바이오켐

    Registration Date : 2024-12-11

    Registration Number : 20130415-196-I-227-11(9)

    Manufacturer Name : MSN Organics Private Limited

    Manufacturer Address : Sy. No. 224/A, Bibinagar(Village), Bibinagar(Mandal), Yadadri Bhuvanagiri District, Telangana, Pincode: 508 126, India

     VMF Others AUDIT
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    07

    Montelukast Sodium

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

    American Thoracic Society
    Not Confirmed
    arrow

    Montelukast Sodium

    India

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

    arrow
    American Thoracic Society
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-05-04

    Pay. Date : 2015-04-29

    DMF Number : 20580

    Submission : 2007-06-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-091 - Rev 01

    Issue Date : 2025-02-17

    Type : Chemical

    Substance Number : 2583

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2019-08-16

    Valid Till : 2025-08-15

    Written Confirmation Number : WC-0022

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 50370-0003

    Start Marketing Date : 2010-04-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2024-06-28

    Registration Number : 20200221-209-J-431(A)

    Manufacturer Name : MSN Pharmachem Private Limited

    Manufacturer Address : Plot. No. 182 to 186 ,192-A, 193 to 197 & 212/A,B,C,D,Phase-II, IDA Pashamylaram, Pashamylaram(Village), Patancheru(Mandal), Sangareddy District, Telangana, Pincode-502 307, India

     VMF Others AUDIT
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    08

    Moxifloxacin Hydrochloride

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

    American Thoracic Society
    Not Confirmed
    arrow

    Moxifloxacin Hydrochloride

    India

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

    arrow
    American Thoracic Society
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-11

    Pay. Date : 2013-07-02

    DMF Number : 20755

    Submission : 2007-08-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2015-360 - Rev 02

    Issue Date : 2024-04-30

    Type : Chemical

    Substance Number : 2254

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2019-08-16

    Valid Till : 2025-08-15

    Written Confirmation Number : WC-0022

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 50370-0001

    Start Marketing Date : 2010-04-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2021-02-25

    Registration Number : 20210225-209-J-841

    Manufacturer Name : MSN Pharmachem Private Limited

    Manufacturer Address : Plot No.: 182 to 186, 192-A, 193 to 197 & Plot No. 212/A, B, C, D, Phase-II, IDA Pashamylaram, Pashamylaram(Village), Patancheru(Mandal), Sangareddy District, Pin Code - 502 307, Telangana, India

     VMF Others AUDIT
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    09

    Pantoprazole Sodium

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

    American Thoracic Society
    Not Confirmed
    arrow

    Pantoprazole Sodium

    India

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

    arrow
    American Thoracic Society
    Not Confirmed
    • fda
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-10-22

    Pay. Date : 2014-10-17

    DMF Number : 20850

    Submission : 2007-09-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-274 - Rev 01

    Issue Date : 2025-02-21

    Type : Chemical

    Substance Number : 2296

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0021n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 72640-008

    Start Marketing Date : 2019-09-09

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Rosuvastatin Calcium

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

    American Thoracic Society
    Not Confirmed
    arrow

    Rosuvastatin Calcium

    India

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

    arrow
    American Thoracic Society
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-11

    Pay. Date : 2013-07-03

    DMF Number : 20712

    Submission : 2007-07-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-454 - Rev 01

    Issue Date : 2024-10-02

    Type : Chemical

    Substance Number : 2631

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0021n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 72640-013

    Start Marketing Date : 2020-01-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : JSP Co., Ltd.

    Registration Date : 2023-03-23

    Registration Number : 20190220-209-J-215(13)

    Manufacturer Name : MSN Laboratories Private Limited

    Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), Sangareddy District, Pin code : 502 329, Telangana, India.

     VMF Others AUDIT
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    USDMF

    read-more
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    01

    "clopidogrel Bisulfate Usp"

    India
    American Thoracic Society
    Not Confirmed
    arrow

    02

    "levothyroxine Sodium Usp"

    India
    American Thoracic Society
    Not Confirmed
    arrow

    03

    "tenofovir Alafenamide Monofumarate"

    India
    American Thoracic Society
    Not Confirmed
    arrow

    04

    (2r,3r)-3(3-methoxy Phenyl)-n,n,2-tr...

    India
    American Thoracic Society
    Not Confirmed
    arrow

    05

    Abaloparatide

    India
    American Thoracic Society
    Not Confirmed
    arrow

    Abaloparatide

    India
    arrow
    American Thoracic Society
    Not Confirmed
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    MSN Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-05-16

    Pay. Date : 2022-05-06

    DMF Number : 34697

    Submission : 2020-05-30

    Status : Active

    Type : II

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    06

    Abemaciclib

    India
    American Thoracic Society
    Not Confirmed
    arrow

    07

    Abemaciclib

    India
    American Thoracic Society
    Not Confirmed
    arrow

    08

    Abiraterone

    India
    STLE Annual Meeting
    Not Confirmed
    arrow

    09

    Abiraterone Acetate Usp

    India
    American Thoracic Society
    Not Confirmed
    arrow

    10

    Abiraterone Acetate Usp [route Code ...

    India
    American Thoracic Society
    Not Confirmed
    arrow
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    JDMF

    read-more
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    01

    Abiraterone Acetate USP

    JDMF

    STLE Annual Meeting
    Not Confirmed
    arrow

    Abiraterone Acetate USP

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
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    MSN Laboratories

    Registration Number : 304MF10113

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

    Initial Date of Registration : 2022-08-03

    Latest Date of Registration : 2024-10-10

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    Market
    Place

    02

    Ambrisentan

    JDMF

    STLE Annual Meeting
    Not Confirmed
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    Ambrisentan

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
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    MSN Laboratories

    Registration Number : 302MF10087

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

    Initial Date of Registration : 2020-07-22

    Latest Date of Registration : 2021-05-10

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    Market
    Place

    03

    Bosutinib Monohydrate [Form I] (BV)

    JDMF

    STLE Annual Meeting
    Not Confirmed
    arrow

    Bosutinib Monohydrate [Form I] (BV)

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
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    MSN Laboratories

    Registration Number : 307MF10038

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

    Initial Date of Registration : 2025-02-26

    Latest Date of Registration : 2025-02-26

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    Market
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    04

    Dapagliflozin (Amorphous)

    JDMF

    STLE Annual Meeting
    Not Confirmed
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    Dapagliflozin (Amorphous)

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
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    MSN Laboratories

    Registration Number : 306MF10106

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

    Initial Date of Registration : 2024-07-24

    Latest Date of Registration : 2024-07-24

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    05

    Duloxetine hydrochloride

    JDMF

    STLE Annual Meeting
    Not Confirmed
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    Duloxetine hydrochloride

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
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    MSN Laboratories

    Registration Number : 229MF10088

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

    Initial Date of Registration : 2017-04-26

    Latest Date of Registration : 2022-11-16

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    Market
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    06

    Dutasteride

    JDMF

    STLE Annual Meeting
    Not Confirmed
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    Dutasteride

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
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    MSN Laboratories

    Registration Number : 230MF10024

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

    Initial Date of Registration : 2018-02-14

    Latest Date of Registration : 2018-02-14

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    07

    Ezetimibe

    JDMF

    STLE Annual Meeting
    Not Confirmed
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    Ezetimibe

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
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    MSN Laboratories

    Registration Number : 230MF10090

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

    Initial Date of Registration : 2018-07-26

    Latest Date of Registration : 2019-05-16

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    08

    Lacosamide USP

    JDMF

    STLE Annual Meeting
    Not Confirmed
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    Lacosamide USP

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
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    MSN Laboratories

    Registration Number : 306MF10101

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

    Initial Date of Registration : 2024-07-17

    Latest Date of Registration : 2024-07-17

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    09

    Milnacipran Hydrochloride

    JDMF

    STLE Annual Meeting
    Not Confirmed
    arrow

    Milnacipran Hydrochloride

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
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    • WHO-GMP
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    MSN Laboratories

    Registration Number : 305MF10092

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

    Initial Date of Registration : 2023-08-02

    Latest Date of Registration : 2023-08-02

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    10

    Olopatadine hydrochloride

    JDMF

    STLE Annual Meeting
    Not Confirmed
    arrow

    Olopatadine hydrochloride

    India
    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
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    MSN Laboratories

    Registration Number : 224MF10094

    Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...

    Initial Date of Registration : 2012-04-27

    Latest Date of Registration : 2021-06-01

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    01

    Brand Name : ABIRATERONE ACETATE

    India
    STLE Annual Meeting
    Not Confirmed
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    Brand Name : ABIRATERONE ACETATE

    India
    STLE Annual Meeting
    Not Confirmed
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    RLD : No

    TE Code : AB

    ABIRATERONE ACETATE

    MSN Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABIRATERONE ACETATE

    Dosage Strength : 250MG

    Approval Date : 2019-07-10

    Application Number : 210686

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    02

    Brand Name : ABIRATERONE ACETATE

    India
    STLE Annual Meeting
    Not Confirmed
    arrow

    Brand Name : ABIRATERONE ACETATE

    India
    STLE Annual Meeting
    Not Confirmed
    arrow
    • fda
    • EDQM
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    RLD : No

    TE Code : AB

    ABIRATERONE ACETATE

    MSN Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABIRATERONE ACETATE

    Dosage Strength : 500MG

    Approval Date : 2024-04-24

    Application Number : 210686

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    03

    Brand Name : ACYCLOVIR

    India
    STLE Annual Meeting
    Not Confirmed
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    Brand Name : ACYCLOVIR

    India
    STLE Annual Meeting
    Not Confirmed
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    RLD : No

    TE Code : AB

    ACYCLOVIR

    MSN Laboratories

    Dosage Form : SUSPENSION; ORAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 200MG/5ML

    Approval Date : 2023-03-09

    Application Number : 217393

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    04

    Brand Name : AFATINIB

    India
    STLE Annual Meeting
    Not Confirmed
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    Brand Name : AFATINIB

    India
    STLE Annual Meeting
    Not Confirmed
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    RLD :

    TE Code :

    AFATINIB

    MSN Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : AFATINIB

    Dosage Strength : 20MG

    Approval Date :

    Application Number : 210804

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    05

    Brand Name : AFATINIB

    India
    STLE Annual Meeting
    Not Confirmed
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    Brand Name : AFATINIB

    India
    STLE Annual Meeting
    Not Confirmed
    arrow
    • fda
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    RLD :

    TE Code :

    AFATINIB

    MSN Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : AFATINIB

    Dosage Strength : 30MG

    Approval Date :

    Application Number : 210804

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    TE Code :

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    India
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    RLD :

    TE Code :

    AFATINIB

    MSN Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : AFATINIB

    Dosage Strength : 40MG

    Approval Date :

    Application Number : 210804

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    Brand Name : ALBENDAZOLE

    India
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    RLD : No

    TE Code : AB

    ALBENDAZOLE

    MSN Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : ALBENDAZOLE

    Dosage Strength : 200MG

    Approval Date : 2021-01-21

    Application Number : 213435

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ALOGLIPTIN AND METFO...

    India
    American Thoracic Society
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    RLD :

    TE Code :

    ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

    MSN Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : ALOGLIPTIN AND METFORMIN...

    Dosage Strength : 12.5MG/500MG

    Approval Date :

    Application Number : 210212

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    TE Code :

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    India
    STLE Annual Meeting
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    RLD :

    TE Code :

    ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

    MSN Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : ALOGLIPTIN AND METFORMIN...

    Dosage Strength : 12.5MG/1000MG

    Approval Date :

    Application Number : 210212

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    TE Code :

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    India
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    RLD :

    TE Code :

    ALOGLIPTIN BENZOATE

    MSN Laboratories

    Dosage Form : TABLET; ORAL

    Proprietary Name : ALOGLIPTIN

    Dosage Strength : EQ 6.25MG BASE

    Approval Date :

    Application Number : 210213

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    01

    Calcobutrol Sodium

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

    American Thoracic Society
    Not Confirmed
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    Calcobutrol Sodium

    India

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

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    American Thoracic Society
    Not Confirmed
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36940

    Submission : 2022-03-31

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 72640-023

    Start Marketing Date : 2022-03-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    FDA

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    FDA Audited

    USA
    American Thoracic Society
    Not Confirmed
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    FDA Audited

    USA
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    American Thoracic Society
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-07-21

    MSN Laboratories

    City : Rangareddy District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-07-21

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    FDA Audited

    USA
    American Thoracic Society
    Not Confirmed
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    FDA Audited

    USA
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    American Thoracic Society
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-06-30

    MSN Laboratories

    City : Chandampet

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-06-30

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    FDA Audited

    USA
    American Thoracic Society
    Not Confirmed
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    FDA Audited

    USA
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    American Thoracic Society
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-06-10

    MSN Laboratories

    City : Patancheru, Medak Distric...

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-06-10

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    FDA Audited

    USA
    American Thoracic Society
    Not Confirmed
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    FDA Audited

    USA
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    American Thoracic Society
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-04-03

    MSN Laboratories

    City : Medak District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-04-03

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    FDA Audited

    USA
    American Thoracic Society
    Not Confirmed
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    FDA Audited

    USA
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    American Thoracic Society
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-02-06

    MSN Laboratories

    City : Medak District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-02-06

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    06

    FDA Audited

    USA
    American Thoracic Society
    Not Confirmed
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    FDA Audited

    USA
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    American Thoracic Society
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-10-31

    MSN Laboratories

    City : Bollaram

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-10-31

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    FDA Audited

    USA
    American Thoracic Society
    Not Confirmed
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    FDA Audited

    USA
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    American Thoracic Society
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-13

    MSN Laboratories

    City : Patancheru, Medak Distric...

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-13

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    08

    FDA Audited

    USA
    American Thoracic Society
    Not Confirmed
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    FDA Audited

    USA
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    American Thoracic Society
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-08-30

    MSN Laboratories

    City : Nalgonda District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-08-30

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    09

    FDA Audited

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    American Thoracic Society
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    FDA Audited

    USA
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    American Thoracic Society
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2012-03-09

    MSN Laboratories

    City : Medak District

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2012-03-09

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    FDA Audited

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    American Thoracic Society
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    USA
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    American Thoracic Society
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-08-05

    MSN Laboratories

    City : Patancheru, Medak Distric...

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2011-08-05

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    GDUFA

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    01

    GDUFA fees paid

    USA
    American Thoracic Society
    Not Confirmed
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    GDUFA fees paid

    USA
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    American Thoracic Society
    Not Confirmed
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    Paid in : 2019

    MSN Laboratories

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : MSN LABORATORIES PRIVATE LIMIT...

    Business Address : Unit-II, Sy. No. 50, Kardanu...

    FEI Number : 3008656542

    Country : India

    Paid in : 2019

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    02

    GDUFA fees paid

    USA
    American Thoracic Society
    Not Confirmed
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    GDUFA fees paid

    USA
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    American Thoracic Society
    Not Confirmed
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    MSN Laboratories

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : MSN LABORATORIES PRIVATE LIMIT...

    Business Address : Sy. No. 317, 320, 321, 322, ...

    FEI Number : 3005254981

    Country : India

    Paid in : 2019

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    GDUFA fees paid

    USA
    American Thoracic Society
    Not Confirmed
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    GDUFA fees paid

    USA
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    American Thoracic Society
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    MSN Laboratories

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : MSN Laboratories Private Limit...

    Business Address : Survey No. 1277 & 1319 to 13...

    FEI Number : 3011033544

    Country : India

    Paid in : 2019

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    USA
    American Thoracic Society
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    USA
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    MSN Laboratories

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : MSN ORGANICS PRIVATE LIMITED

    Business Address : Sy. No. 224/A, Bibinagar (Vi...

    FEI Number : 3008822771

    Country : India

    Paid in : 2019

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    MSN Laboratories

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : MSN PHARMACHEM PRIVATE LIMITED

    Business Address : Plot No.: 212/ A,B,C,D, Phas...

    FEI Number : 3006165229

    Country : India

    Paid in : 2019

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    ABOUT THIS PAGE

    Contact MSN Laboratories and get a quotation

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    Find a price of Duloxetine Hydrochloride bulk with DMF, CEP, JDMF, WC offered by MSN Laboratories

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