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    Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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    Honour is a leading global CDMO and specialty chemicals & ingredients manufacturer with seven facilities set to global standards of safety and quality. With our offerings, Honour Synthesis and Honour Specialty, we embrace the science of partnership and possibilities. Our 2500+ team delivers excellence to our pharmaceutical and biotechnology partners through practical solutions. Our commitment to transforming everyday life expands to specialty ingredients for electronics and pharma. Upholding top Environmental, Social, and Governance standards, we collaborate with stakeholders for sustainable, people-centric, transformative outcomes.

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    Nexity, Tower 30, 12th Floor, Survey No. 83/1, Knowledge City, Raidurg, Hydera...
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    DATA COMPILATION #PharmaFlow

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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    01

    Sitagliptin Phosphate

    India

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

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    CPhI WW Frankfurt
    Booth #6.1B62
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    • WHO-GMP
    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
    USDMF arrow-down Click Us! arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-02-16

    Pay. Date : 2016-09-12

    DMF Number : 30857

    Submission : 2016-09-22

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2016-324 - Rev 01

    Issue Date : 2024-12-16

    Type : Chemical

    Substance Number : 2778

    Status : Valid

     JDMF arrow-down
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    Registration Number : 303MF10124

    Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.

    Initial Date of Registration : 2021-08-16

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 69037-0022

    Start Marketing Date : 2016-12-31

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Available Reg. Filing : CN
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    02

    Tadalafil

    India

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

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    CPhI WW Frankfurt
    Booth #6.1B62
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-02-08

    Pay. Date : 2015-09-29

    DMF Number : 29765

    Submission : 2015-12-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-083 - Rev 00

    Issue Date : 2022-07-25

    Type : Chemical

    Substance Number : 2606

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10172

    Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.

    Initial Date of Registration : 2018-12-21

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 69037-0015

    Start Marketing Date : 2003-11-21

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Available Reg. Filing : CN
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    03

    Teriflunomide

    India

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

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    CPhI WW Frankfurt
    Booth #6.1B62
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-11-06

    Pay. Date : 2015-09-08

    DMF Number : 29701

    Submission : 2015-10-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-422 - Rev 00

    Issue Date : 2025-04-11

    Type : Chemical

    Substance Number : 3036

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2023-11-28

    Valid Till : 2025-05-05

    Written Confirmation Number : WC-0362

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 69037-0016

    Start Marketing Date : 2012-09-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Available Reg. Filing : CN
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    04

    Alogliptin Benzoate

    India

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

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    CPhI WW Frankfurt
    Booth #6.1B62
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-09-02

    Pay. Date : 2016-06-13

    DMF Number : 30577

    Submission : 2016-07-18

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 306MF10015

    Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.

    Initial Date of Registration : 2024-01-24

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 69037-0024

    Start Marketing Date : 2013-01-15

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Phamchem Service Co., Ltd.

    Registration Date : 2024-01-24

    Registration Number : Su331-11-ND(3)

    Manufacturer Name : Honour Lab Limited(Unit-III)

    Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd., N.Narsapuram Nakkapalli Mandal, Anakapalli District, Andhra Pradesh, India

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    Available Reg. Filing : ASMF
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    05

    Clobazam

    India

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    CPhI WW Frankfurt
    Booth #6.1B62
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-08-24

    Pay. Date : 2015-05-26

    DMF Number : 29351

    Submission : 2015-06-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-237 - Rev 00

    Issue Date : 2023-02-13

    Type : Chemical

    Substance Number : 1974

    Status : Valid

     JDMF EU-WC NDC arrow-down
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    NDC Package Code : 69037-0009

    Start Marketing Date : 2011-10-21

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF CN arrow-down
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    Available Reg. Filing : CN
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    06

    Empagliflozin

    India

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

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    CPhI WW Frankfurt
    Booth #6.1B62
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-07-05

    Pay. Date : 2017-04-13

    DMF Number : 31523

    Submission : 2017-06-02

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2023-05-22

    Valid Till : 2026-05-27

    Written Confirmation Number : WC-0559

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 69037-0029

    Start Marketing Date : 2014-08-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kyungbo Pharmaceutical Co., Ltd.

    Registration Date : 2024-12-16

    Registration Number : Thu21-10-ND(9)

    Manufacturer Name : Honour Lab Limited(Unit-III)

    Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd., N. Narasapuram Village, Nakkapalli Mandal, Anakapalli District, Andhra Pradesh, India

     VMF ASMF arrow-down
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    Available Reg. Filing : ASMF
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    07

    Fingolimod Hydrochloride

    India

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

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    CPhI WW Frankfurt
    Booth #6.1B62
    • fda
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    • WHO-GMP
    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-20

    Pay. Date : 2014-06-16

    DMF Number : 28225

    Submission : 2014-04-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-171 - Rev 01

    Issue Date : 2023-07-27

    Type : Chemical

    Substance Number : 2988

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 69037-0006

    Start Marketing Date : 2010-09-21

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    08

    Linagliptin

    India

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

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    CPhI WW Frankfurt
    Booth #6.1B62
    • fda
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-03-13

    Pay. Date : 2014-12-23

    DMF Number : 28877

    Submission : 2015-01-07

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 305MF10029

    Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.

    Initial Date of Registration : 2023-02-15

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 69037-0010

    Start Marketing Date : 2014-03-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
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    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2024-09-05

    Registration Number : No. 4579-15-ND(4)

    Manufacturer Name : Honour Lab Limited Unit III

    Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapally Mandal, Anakapalli District - 531 081, Andhra Pradesh, India

     VMF ASMF, CN arrow-down
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    09

    Pirfenidone

    India

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

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    CPhI WW Frankfurt
    Booth #6.1B62
    • fda
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    • WHO-GMP
    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-12-18

    Pay. Date : 2015-09-08

    DMF Number : 29700

    Submission : 2015-11-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-122 - Rev 00

    Issue Date : 2022-10-19

    Type : Chemical

    Substance Number : 2856

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 69037-0013

    Start Marketing Date : 2014-10-15

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Phamchem Service Co., Ltd.

    Registration Date : 2023-12-13

    Registration Number : 20210518-211-J-994(1)

    Manufacturer Name : Honour Lab Limited Unit III

    Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd, N.Narasapuram Village, Nakkapally Mandal, Anakapalli District, Andhra Pradesh, India

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    10

    Ticagrelor

    India

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

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    CPhI WW Frankfurt
    Booth #6.1B62
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-03-13

    Pay. Date : 2014-12-23

    DMF Number : 28879

    Submission : 2015-01-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-131 - Rev 00

    Issue Date : 2024-11-18

    Type : Chemical

    Substance Number : 3087

    Status : Valid

     JDMF EU-WC NDC arrow-down
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    NDC Package Code : 69037-0007

    Start Marketing Date : 2011-07-20

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Lee Sung International Co., Ltd.

    Registration Date : 2018-03-26

    Registration Number : No. 4579-16-ND(2)

    Manufacturer Name : Honour Lab Limited(Unit-III)

    Manufacturer Address : Plot No.4, Hetero Infrastructure SEZ Ltd., N.Narsapuram Village, Nakkapalli Mandal, Anakapalli District-531081, Andhra Pradesh, India

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    01

    Clobazam

    India
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

    Honour Lab

    Certificate Numbers : R1-CEP 2016-237 - Rev 00

    Status : Valid

    Issue Date : 2023-02-13

    Type : Chemical

    Substance Number : 1974

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    Certificate Numbers : R0-CEP 2019-171 - Rev 01

    Status : Valid

    Issue Date : 2023-07-27

    Type : Chemical

    Substance Number : 2988

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    Certificate Numbers : R1-CEP 2016-122 - Rev 00

    Status : Valid

    Issue Date : 2022-10-19

    Type : Chemical

    Substance Number : 2856

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    Sitagliptin phosphate monohydrate

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    Certificate Numbers : CEP 2016-324 - Rev 01

    Status : Valid

    Issue Date : 2024-12-16

    Type : Chemical

    Substance Number : 2778

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    Tadalafil

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    Certificate Numbers : R1-CEP 2016-083 - Rev 00

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    Issue Date : 2022-07-25

    Type : Chemical

    Substance Number : 2606

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    Certificate Numbers : CEP 2023-422 - Rev 00

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    Issue Date : 2025-04-11

    Type : Chemical

    Substance Number : 3036

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    Certificate Numbers : CEP 2022-131 - Rev 00

    Status : Valid

    Issue Date : 2024-11-18

    Type : Chemical

    Substance Number : 3087

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