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    About

    Laurus Labs is a leading research and development-driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. Laurus Labs also manufactures APIs in oncology and other therapeutic areas. Its strategic and early investments in R&D and manufacturing infrastructure have enabled it to beco...
    Laurus Labs is a leading research and development-driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. Laurus Labs also manufactures APIs in oncology and other therapeutic areas. Its strategic and early investments in R&D and manufacturing infrastructure have enabled it to become one of the leading suppliers of APIs in the ARV therapeutic area. Out of Ten largest generic pharmaceutical companies in the world, by revenues, are our customers.

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    CONTACT DETAILS

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    2nd Floor, Serene Chambers, Rd # 7,Banjara Hills, Hyderabad 500 034
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    +91 40 3980 4333
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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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    Laurus Labs Q4 FY25 PAT up 208% to Rs. 234 Cr
    Laurus Labs Q4 FY25 PAT up 208% to Rs. 234 Cr

    24 Apr 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/laurus-labs-q4-fy25-pat-up-208-to-rs-234-cr-17072

    INDPHARMAPOST
    24 Apr 2025
    Share Share
    Indian pharma stocks decline after Trump again threatens tariffs
    Indian pharma stocks decline after Trump again threatens tariffs

    09 Apr 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/indian-pharma-stocks-decline-after-trump-again-threatens-tariffs-2025-04-09/https://www.reuters.com/business/healthcare-pharmaceuticals/indian-pharma-stocks-decline-after-trump-again-threatens-tariffs-2025-04-09/

    REUTERS
    09 Apr 2025
    Share Share
    Laurus Labs posts Q3 FY25 consolidated PAT higher at Rs. 92.30 Cr
    Laurus Labs posts Q3 FY25 consolidated PAT higher at Rs. 92.30 Cr

    28 Jan 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/laurus-labs-posts-q3-fy25-consolidated-pat-higher-at-rs-9230-cr-16716

    INDPHARMAPOST
    28 Jan 2025
    Share Share
    Laurus Labs' arm gets Form 483 from FDA 'adverse experience' probe
    Laurus Labs' arm gets Form 483 from FDA 'adverse experience' probe

    22 Jan 2025

    // CNBCTV

    https://www.cnbctv18.com/market/stocks/laurus-labs-share-price-arm-us-fda-form-483-post-marketing-adverse-drug-experience-pade-inspection-19544707.htm

    CNBCTV
    22 Jan 2025
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    Laurus Labs invests in Laurus Bio
    Laurus Labs invests in Laurus Bio

    09 Dec 2024

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/laurus-labs-invests-in-laurus-bio-16516

    INDPHARMAPOST
    09 Dec 2024
    Share Share
    Laurus Labs posts Financial Results Q2 FY 2025
    Laurus Labs posts Financial Results Q2 FY 2025

    24 Oct 2024

    // PRESS RELEASE

    https://www.lauruslabs.com/Investors/PDF/PressReleases/PressRelease16092024.pdf

    PRESS RELEASE
    24 Oct 2024
    Share Share

    ALL APIs

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    01

    Gemcitabine

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

    STLE Annual Meeting
    Not Confirmed
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    Gemcitabine

    India

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

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    STLE Annual Meeting
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-23

    Pay. Date : 2012-11-16

    DMF Number : 22800

    Submission : 2009-05-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-026 - Rev 02

    Issue Date : 2023-01-24

    Type : Chemical

    Substance Number : 2306

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10069

    Registrant's Address : 2nd Floor, Serene Chambers, Road No#7, Banjara Hills, Hyderabad, Telangana, INDIA

    Initial Date of Registration : 2018-06-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-07-03

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0213

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42385-748

    Start Marketing Date : 2009-05-16

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samyang Holdings Co., Ltd.

    Registration Date : 2021-07-13

    Registration Number : 20110516-86-D-100-15(6)

    Manufacturer Name : Laurus Labs Limited

    Manufacturer Address : Plot No. 21, Jawaharlal Nehru Pharma City Parawada, Anakapalli-531 021,Andhra Pradesh, India

     VMF Others AUDIT
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    02

    Metformin

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

    STLE Annual Meeting
    Not Confirmed
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    Metformin

    India

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

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    STLE Annual Meeting
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-06-14

    Pay. Date : 2016-04-04

    DMF Number : 30114

    Submission : 2016-05-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-319 - Rev 01

    Issue Date : 2023-01-24

    Type : Chemical

    Substance Number : 931

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10025

    Registrant's Address : 2nd Floor, Serene Chambers, Road No:7, Banjara Hills, Hyderabad - 500034, Telangana, India

    Initial Date of Registration : 2024-02-07

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-07-03

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0213

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42385-501

    Start Marketing Date : 2016-04-19

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sangjin Corporation

    Registration Date : 2024-04-16

    Registration Number : 20240416-37-C-410-30

    Manufacturer Name : Laurus Labs Limited

    Manufacturer Address : Unit-II, Plot No. 19, 20 & 21, Western Sector, APSEZ, Gurajapalem Village, Rambilli Mandal, Anakapalli District -531011, Andhra Pradesh, India

     VMF Others AUDIT
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    03

    Abacavir Sulfate

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

    STLE Annual Meeting
    Not Confirmed
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    Abacavir Sulfate

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-05-20

    Pay. Date : 2014-11-21

    DMF Number : 28818

    Submission : 2014-12-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-353 - Rev 02

    Issue Date : 2024-11-27

    Type : Chemical

    Substance Number : 2589

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-07-03

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0213

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    04

    Bortezomib

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

    STLE Annual Meeting
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    Bortezomib

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-06

    Pay. Date : 2012-12-18

    DMF Number : 26774

    Submission : 2012-12-19

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 228MF10207

    Registrant's Address : 2nd Floor, Serene Chambers, Road No#7, Banjara Hills, Hyderabad, Telangana, INDIA

    Initial Date of Registration : 2016-11-02

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2023-07-03

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0213

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42385-716

    Start Marketing Date : 2012-12-18

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharma Science Korea Co., Ltd.

    Registration Date : 2022-02-04

    Registration Number : No.87-25-ND(1)

    Manufacturer Name : Laurus Labs Limited(Unit-1)

    Manufacturer Address : Plot No. 21, Jawaharlal Nehru Pharma City,Parawada(M), Visakhapatnam-531021,Andhra Pradesh,India

     VMF Others AUDIT
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    05

    Hydroxychloroquine Sulphate

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

    STLE Annual Meeting
    Not Confirmed
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    Hydroxychloroquine Sulphate

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-10-19

    Pay. Date : 2017-08-30

    DMF Number : 31956

    Submission : 2017-09-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-129 - Rev 02

    Issue Date : 2023-01-25

    Type : Chemical

    Substance Number : 2849

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-07-03

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0213

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    06

    Imatinib Mesylate

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

    STLE Annual Meeting
    Not Confirmed
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    Imatinib Mesylate

    India

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

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    STLE Annual Meeting
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-20

    Pay. Date : 2013-05-13

    DMF Number : 27089

    Submission : 2013-05-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-245 - Rev 01

    Issue Date : 2023-01-18

    Type : Chemical

    Substance Number : 2736

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-07-03

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0213

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42385-316

    Start Marketing Date : 2013-05-09

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    07

    Irinotecan Hydrochloride

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

    STLE Annual Meeting
    Not Confirmed
    arrow

    Irinotecan Hydrochloride

    India

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

    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-11-02

    Pay. Date : 2018-10-31

    DMF Number : 22296

    Submission : 2008-11-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-292 - Rev 02

    Issue Date : 2023-12-11

    Type : Chemical

    Substance Number : 2675

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-07-03

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0213

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42385-711

    Start Marketing Date : 2008-11-21

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Iksoo Pharmaceutical Co., Ltd.

    Registration Date : 2021-03-16

    Registration Number : 20210316-210-J-880

    Manufacturer Name : Laurus Labs Private Limited

    Manufacturer Address : Plot No. 21, Jawaharlal Nehru Pharma City, Parawada, Anakapalli-531021, Andhra Pradesh, India

     VMF Others AUDIT
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    08

    Lamivudine

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

    STLE Annual Meeting
    Not Confirmed
    arrow

    Lamivudine

    India

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

    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-08-04

    Pay. Date : 2017-06-28

    DMF Number : 31854

    Submission : 2017-07-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-133 - Rev 03

    Issue Date : 2025-02-26

    Type : Chemical

    Substance Number : 2217

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-07-03

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0213

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42385-714

    Start Marketing Date : 2017-07-07

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea MSD Co., Ltd.

    Registration Date : 2022-01-10

    Registration Number : 20220110-209-J-1202

    Manufacturer Name : Laurus Labs Limited (Unit 1)

    Manufacturer Address : Plot No.21, Jawaharlal Nehru Pharma City, Parawada, Anakapalli-531021, Andhra Pradesh, India

     VMF Others AUDIT
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    Market
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    09

    Montelukast Sodium

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

    STLE Annual Meeting
    Not Confirmed
    arrow

    Montelukast Sodium

    India

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

    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-24

    Pay. Date : 2017-03-13

    DMF Number : 23736

    Submission : 2010-04-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2013-311 - Rev 02

    Issue Date : 2024-11-25

    Type : Chemical

    Substance Number : 2583

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-07-03

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0213

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42385-709

    Start Marketing Date : 2010-04-16

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hanyoung Farm Co., Ltd.

    Registration Date : 2022-07-06

    Registration Number : 20190426-209-J-170(1)

    Manufacturer Name : Laurus Labs Limited

    Manufacturer Address : Plot No. 21, Jawaharlal Nehru Pharma City, Parawada, Anakapalli-531 021, Andhra Pradesh, India.

     VMF Others AUDIT
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    10

    Pemetrexed Disodium

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

    STLE Annual Meeting
    Not Confirmed
    arrow

    Pemetrexed Disodium

    India

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

    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-09-10

    Pay. Date : 2014-04-08

    DMF Number : 26431

    Submission : 2012-09-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-188 - Rev 00

    Issue Date : 2024-12-06

    Type : Chemical

    Substance Number : 3046

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-07-03

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0213

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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