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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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    MSN House Plot No: C-24 Industrial Estate, Sanathnagar Hyderabad - 18 Telangan...
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

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    https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

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    16 Dec 2024
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    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    A watershed moment in the journey of a drug is when it transitions from being a patented, high‐priced innovator product to an affordable generic.Through an inaugural approval, or a “first generic”,  the US Food Drug Administration (FDA) permits a manufacturer to market a generic version of a brand‐name drug — a process that, when successful, grants 180 days of exclusivity to the generic sponsor. This exclusivity is especially valuable when the drug in question is a blockbuster.In FDA’s fiscal year 2024 (i.e. from October 1, 2023 to September 30, 2024), the number of first-time generic drug approvals decreased by 21.3 percent — from 89 in FY 2023 to 70 in FY 2024, the lowest in at least nine years.Lupin emerged as a frontrunner in first generics, increasing its approvals from three in FY 2023 to seven in FY 2024, Apotex and Zydus Lifesciences from four to six, and Dr. Reddy’s from two to four. In contrast, Teva, Amneal, and Sun Pharma experienced a decline.Overall, neurology led the way with 10 approvals, while immunology saw eight, including three approvals in dermatology. Oncology and cardiology/vascular disease saw six approvals each. Ophthalmology saw five while psychiatry, and infectious diseases each contributed four approvals. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Novartis’ top seller Entresto, blockbuster Tasigna among six key drugs hit by generic rivalsIn 2024, the tide turned sharply for Novartis as it lost exclusivity for six of its drugs. Among them was its blockbuster Entresto, that has generated US$ 29.2 billion in revenue so far, including US$ 7.8 billion in 2024.A combination of sacubitril and valsartan, Entresto has transformed heart failure management. Entresto was the primary driver of Novartis’ sales growth last year. It was also one of the 10 drugs selected by the Biden administration in 2023 for Medicare price negotiations. Novartis has been fighting a fierce legal battle to protect Entresto from generic competition. In 2024, Entresto’s generic saga reached a crescendo. Alembic Pharmaceuticals, Laurus Labs, and Crystal Pharmaceutical’s generic versions of Entresto received FDA approval in May last year. But the Swiss drugmaker has noted that as of January 2025, there were no Entresto generics available in the US.Novartis’ Tasigna (nilotinib) has been a cornerstone in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Apotex won approvals for generics of 50 mg, 150 mg, and 200 mg of nilotinib formulations, thereby offering a more affordable option for both adult and pediatric patients. Owing to the generics, Tasigna’s sales fell 10 percent in 2024.Novartis’ Mekinist (trametinib), Votrient (pazopanib), Rydapt (midostaurin), and Promacta (eltrombopag) have long been critical treatments in oncology and hematology. With generic competition hitting these key assets, Novartis is now aggressively forging deals to strengthen its pipeline. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  FDA clears first generics for Neurocrine’s Ingrezza, Supernus’s Gocovri, ALS drugsIn psychiatry, Neurocrine Biosciences’ Ingrezza (valbenazine) capsules have carved out a niche for themselves as a first-in-class treatment for tardive dyskinesia, a movement disorder that can develop as a side effect of long-term use of antipsychotic meds. Two generics for Ingrezza from India’s Zydus and Lupin bagged FDA approval, as Ingrezza sales topped US$ 2.3 billion last year.Zydus also won first generic approval for Supernus Pharmaceuticals’ Gocovri (amantadine) extended-release capsules, which is a treatment of dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy.Four companies received FDA approvals for their first generics of Mitsubishi Tanabe’s patented drug Radicava (edaravone). These are Dr. Reddy’s Laboratories, Gland Pharma (a Fosun Pharmaceutical subsidiary), Hikma and Long Grove. Radicava is a drug that treats amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Another treatment for ALS from Italfarmaco — Tiglutik (riluzole) — received a first generic when FDA okayed Alkem Laboratories riluzole oral suspension. The med helps slow disease progression. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Pfizer’s Ibrance, Gilead’s Descovy, Lilly’s Olumiant treatment come under generic pressureIn oncology, Synthon Pharmaceuticals launched its generic version of Pfizer’s Ibrance (palbociclib) tablets. Generating sales of US$ 4.4 billion in 2024, this groundbreaking CDK4/6 inhibitor is Pfizer’s best-selling cancer drug. It has transformed treatment for hormone receptor-positive, HER2-negative advanced breast cancer by halting cancer cell division and significantly extending progression-free survival when combined with endocrine therapy.Descovy, a combination of emtricitabine and tenofovir alafenamide, stands as one of the most important therapies in the fight against HIV infection and related conditions. Originally developed by Gilead Sciences, Descovy has played a pivotal role in modern antiretroviral therapy, contributing US$ 2.1 billion to Gilead’s revenue in 2024. Apotex’s first generic approval for Descovy marked its second copycat for a blockbuster drug in 2024. The other generic approval it got its hands on was for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), a blood thinner that posted sales of € 845 million (US$ 883 million) in 2023.In immunology, Eli Lilly’s Olumiant (baricitinib) has emerged as an important therapy for treating inflammatory conditions such as rheumatoid arthritis. Aurobindo Pharma bagged FDA approval for generic baricitinib tablets.Ipsen’s Somatuline Depot (lanreotide) injection, a treatment for neuroendocrine tumors and endocrine disorders that generated about € 1.07 billion (US$1.1 billion) in 2023 sales, also has a generic now, with Cipla’s subsidiary InvaGen Pharmaceuticals receiving an FDA approval. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) FDA okays copycats for opioid withdrawal med Lucemyra, weight loss drug Qsymia, contraceptive SlyndFDA also demonstrated a focused commitment to addressing two of the nation’s biggest public health concerns — the opioid crisis and obesity. Lucemyra (lofexidine), originally developed by US WorldMeds, is a non-opioid medication indicated for mitigating symptoms associated with acute opioid withdrawal and facilitating the completion of opioid discontinuation treatment. The introduction of Indoco Remedies’ generic version is poised to expand access to this critical therapy by offering a cost-effective alternative for managing substance use disorders.Vivus’ Qsymia (phentermine/topiramate), a chronic weight management therapy, also received a first generic. Actavis’ generic for Qsymia provides a more accessible option to patients striving to lose weight. Actavis is a subsidiary of Teva.FDA also approved Lupin’s first generic version of Insud Pharma’s Slynd—a progestin‑only contraceptive containing 4 mg drospirenone for use by females of reproductive potential to prevent pregnancy. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Our viewOver the next two years, several blockbusters such as Novo Nordisk’s Ozempic (semaglutide), AstraZeneca’s Farxiga (dapagliflozin), Bristol Myers Squibb’s Revlimid (lenalidomide) and its Pfizer partnered drug Eliquis (apixaban) stand to lose their patent protection. We expect more patent litigations and some exciting innovations in the generics space.
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    Impressions: 626

    https://www.pharmacompass.com/radio-compass-blog/fda-s-first-generic-approvals-slump-21-in-2024-novartis-top-seller-entresto-cancer-blockbuster-tasigna-lead-2024-patent-cliff

    #PharmaFlow by PHARMACOMPASS
    20 Feb 2025
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    NEWS #PharmaBuzz

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    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
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    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
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    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
    Share Share
    Judge upholds MSN's generic Entresto nod amid Novartis challenge
    Judge upholds MSN's generic Entresto nod amid Novartis challenge

    19 Oct 2024

    // FIERCE PHARMA

    https://www.fiercepharma.com/pharma/judge-upholds-msns-generic-entresto-approval-novartis-continues-attempts-defend-heart

    FIERCE PHARMA
    19 Oct 2024
    Share Share
    Novartis loses latest bid to block generic version of blockbuster heart drug
    Novartis loses latest bid to block generic version of blockbuster heart drug

    17 Oct 2024

    // REUTERS

    https://www.reuters.com/legal/litigation/novartis-loses-latest-bid-block-generic-version-blockbuster-heart-drug-2024-10-16/

    REUTERS
    17 Oct 2024
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    Exelixis Updates On Second Patent Litigation Trial With MSN Labs
    Exelixis Updates On Second Patent Litigation Trial With MSN Labs

    15 Oct 2024

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20241015378225/en

    BUSINESSWIRE
    15 Oct 2024
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    ALL APIs

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    01

    Duloxetine Hydrochloride

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

    Biotech Digital Meet
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    Duloxetine Hydrochloride

    India

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

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    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 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 2021-314 - Rev 00

    Issue Date : 2023-12-06

    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 : 2024-12-31

    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

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    02

    Lacosamide

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

    Biotech Digital Meet
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    Lacosamide

    India

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

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    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 : 2024-12-31

    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. 212/A, B, C, D, Phase-II, IDA Pashamylaram, Pashamylaram(Village), Patancheru(Mandal), Sangareddy District, Pin Code - 502 307, Telangana, India

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    03

    Oseltamivir Phosphate

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

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    Oseltamivir Phosphate

    India

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

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    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 : 50370-0028

    Start Marketing Date : 2011-12-29

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    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.

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    04

    Voriconazole

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

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    Voriconazole

    India

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    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
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    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 : 14501-0014

    Start Marketing Date : 2010-03-26

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    Dutasteride

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

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    Dutasteride

    India

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    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 Inactive-api
    ✖

    Certificate Number : R1-CEP 2015-252 - Rev 00

    Issue Date : 2021-01-15

    Type : Chemical

    Substance Number : 2641

    Status : Withdrawn by Holder

     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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : IMCD Korea Co., Ltd.

    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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    06

    Pioglitazone Hydrochloride

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

    Biotech Digital Meet
    Not Confirmed
    arrow

    Pioglitazone Hydrochloride

    India

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

    arrow
    Biotech Digital Meet
    Not Confirmed
    • fda
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    ✖

    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 : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : SG Biochem Co., Ltd.

    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

    Biotech Digital Meet
    Not Confirmed
    arrow

    Montelukast Sodium

    India

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

    arrow
    Biotech Digital Meet
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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 : R1-CEP 2012-091 - Rev 00

    Issue Date : 2019-09-13

    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 : 2024-12-31

    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

    Biotech Digital Meet
    Not Confirmed
    arrow

    Moxifloxacin Hydrochloride

    India

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

    arrow
    Biotech Digital Meet
    Not Confirmed
    • fda
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    • WHO-GMP
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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 2007-355 - Rev 05

    Issue Date : 2024-08-02

    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 : 2024-12-31

    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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    Market
    Place

    09

    Pantoprazole Sodium

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

    Biotech Digital Meet
    Not Confirmed
    arrow

    Pantoprazole Sodium

    India

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

    arrow
    Biotech Digital Meet
    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 : R0-CEP 2019-274 - Rev 00

    Issue Date : 2020-03-17

    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 : 14501-0025

    Start Marketing Date : 2010-03-26

    End Marketing Date : 2024-12-31

    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

    Biotech Digital Meet
    Not Confirmed
    arrow

    Rosuvastatin Calcium

    India

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

    arrow
    Biotech Digital Meet
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    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 2020-057 - Rev 01

    Issue Date : 2024-03-20

    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 : 14501-0002

    Start Marketing Date : 2010-03-22

    End Marketing Date : 2024-12-31

    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
    Biotech Digital Meet
    Not Confirmed
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    02

    "levothyroxine Sodium Usp"

    India
    Biotech Digital Meet
    Not Confirmed
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    03

    "tenofovir Alafenamide Monofumarate"

    India
    Biotech Digital Meet
    Not Confirmed
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    04

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

    India
    Biotech Digital Meet
    Not Confirmed
    arrow

    05

    Abaloparatide

    India
    Biotech Digital Meet
    Not Confirmed
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    06

    Abemaciclib

    India
    Biotech Digital Meet
    Not Confirmed
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    07

    Abemaciclib

    India
    Biotech Digital Meet
    Not Confirmed
    arrow

    08

    Abiraterone

    India
    Biotech Digital Meet
    Not Confirmed
    arrow

    09

    Abiraterone Acetate Usp

    India
    Biotech Digital Meet
    Not Confirmed
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    10

    Abiraterone Acetate Usp [route Code ...

    India
    Biotech Digital Meet
    Not Confirmed
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    CEP/COS

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    01

    Albendazole

    CEP/COS

    Biotech Digital Meet
    Not Confirmed
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    02

    Alfuzosin hydrochloride

    CEP/COS

    Biotech Digital Meet
    Not Confirmed
    arrow

    03

    all-rac-Phytomenadione

    CEP/COS

    Biotech Digital Meet
    Not Confirmed
    arrow

    04

    Almotriptan malate

    CEP/COS

    Biotech Digital Meet
    Not Confirmed
    arrow

    05

    Aprepitant, Form I

    CEP/COS

    Biotech Digital Meet
    Not Confirmed
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    06

    Aprepitant, Route code AP

    CEP/COS

    Biotech Digital Meet
    Not Confirmed
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    07

    Aripiprazole, Type-1

    CEP/COS

    Biotech Digital Meet
    Not Confirmed
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    08

    Atazanavir sulfate

    CEP/COS

    Biotech Digital Meet
    Not Confirmed
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    09

    Atomoxetine hydrochloride

    CEP/COS

    Biotech Digital Meet
    Not Confirmed
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    10

    Atorvastatin calcium, Trihydrate

    CEP/COS

    Biotech Digital Meet
    Not Confirmed
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    JDMF

    read-more
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    01

    Abiraterone Acetate USP

    JDMF

    Biotech Digital Meet
    Not Confirmed
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    Abiraterone Acetate USP

    India
    arrow
    Biotech Digital Meet
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    Digital Content Digital Content

    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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    02

    Ambrisentan

    JDMF

    Biotech Digital Meet
    Not Confirmed
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    Ambrisentan

    India
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    Biotech Digital Meet
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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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    03

    Dapagliflozin (Amorphous)

    JDMF

    Biotech Digital Meet
    Not Confirmed
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    Dapagliflozin (Amorphous)

    India
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    Biotech Digital Meet
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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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    Market
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    04

    Duloxetine hydrochloride

    JDMF

    Biotech Digital Meet
    Not Confirmed
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    Duloxetine hydrochloride

    India
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    Biotech Digital Meet
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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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    05

    Dutasteride

    JDMF

    Biotech Digital Meet
    Not Confirmed
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    Dutasteride

    India
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    Biotech Digital Meet
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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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    06

    Ezetimibe

    JDMF

    Biotech Digital Meet
    Not Confirmed
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    Ezetimibe

    India
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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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    07

    Lacosamide USP

    JDMF

    Biotech Digital Meet
    Not Confirmed
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    Lacosamide USP

    India
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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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    08

    Milnacipran Hydrochloride

    JDMF

    Biotech Digital Meet
    Not Confirmed
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    Milnacipran Hydrochloride

    India
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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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    09

    Olopatadine hydrochloride

    JDMF

    Biotech Digital Meet
    Not Confirmed
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    Olopatadine hydrochloride

    India
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    Biotech Digital Meet
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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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    10

    Oseltamivir phosphate

    JDMF

    Biotech Digital Meet
    Not Confirmed
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    Oseltamivir phosphate

    India
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    Biotech Digital Meet
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    MSN Laboratories

    Registration Number : 229MF10042

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

    Initial Date of Registration : 2017-02-15

    Latest Date of Registration : 2023-12-13

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    EU WC

    read-more
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    01

    Abemaciclib IH

    India
    Biotech Digital Meet
    Not Confirmed
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    02

    Abiraterone IH/Abiraterone A...

    India
    Biotech Digital Meet
    Not Confirmed
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    03

    Abiraterone IH

    India
    Biotech Digital Meet
    Not Confirmed
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    04

    Acalabrutinib IH

    India
    Biotech Digital Meet
    Not Confirmed
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    05

    Aclidinium Bromide IH

    India
    Biotech Digital Meet
    Not Confirmed
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    06

    Afatinib Dimaleate IHS

    India
    Biotech Digital Meet
    Not Confirmed
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    07

    Agomelatine (IH)

    India
    Biotech Digital Meet
    Not Confirmed
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    08

    Albendazole USP/EP

    India
    Biotech Digital Meet
    Not Confirmed
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    09

    Alcaftadine IH

    India
    Biotech Digital Meet
    Not Confirmed
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    10

    Alcaftadine IH

    India
    Biotech Digital Meet
    Not Confirmed
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    01

    agomelatine

    India
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    agomelatine

    India
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    MSN Laboratories

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2023-10-05

    Registration Number : 434-59-ND

    Manufacturer Name : MSN Pharmachem Private Limited

    Manufacturer Address : Plot No. 212/A, B, C, D, Phase-II, IDA Pashamylaram, Pashamylaram(Village), Patancher...

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    Alogliptin benzoate

    India
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    Alogliptin benzoate

    India
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    MSN Laboratories

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2024-04-03

    Registration Number : 173-48-ND

    Manufacturer Name : MSN Laboratories Private Limit...

    Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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    03

    Aripiprazole (micronized)

    India
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    Aripiprazole (micronized)

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    MSN Laboratories

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2023-04-28

    Registration Number : 20230428-209-J-1471

    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, Pas...

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    04

    Atorvastatin calcium

    India
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    Atorvastatin calcium

    India
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    MSN Laboratories

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2011-12-09

    Registration Number : 20111209-132-H-186-14

    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, Pas...

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    05

    Atorvastatin calcium

    India
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    Atorvastatin calcium

    India
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    MSN Laboratories

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2015-11-17

    Registration Number : 20150114-132-H-269-29(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, Pas...

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    06

    Atorvastatin calcium

    India
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    Atorvastatin calcium

    India
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    MSN Laboratories

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2015-01-14

    Registration Number : 20150114-132-H-269-29

    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, Pas...

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    07

    Atorvastatin calcium

    India
    Biotech Digital Meet
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    Atorvastatin calcium

    India
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    Biotech Digital Meet
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    MSN Laboratories

    Registrant Name : EQ Bio Co., Ltd.

    Registration Date : 2024-02-01

    Registration Number : 20150114-132-H-269-29(2)

    Manufacturer Name : MSN Pharmachem Private Limited

    Manufacturer Address : Plot. No.212/A,B,C,D,Phase-II, IDA Pashamylaram, Pashamylaram(Village), Patancheru(Ma...

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    08

    Baricitinib

    India
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    Baricitinib

    India
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    MSN Laboratories

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2023-11-30

    Registration Number : No. 163-32-ND(B)

    Manufacturer Name : MSN Laboratories Private Limit...

    Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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    09

    Baricitinib

    India
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    Baricitinib

    India
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    MSN Laboratories

    Registrant Name : Grace Farm

    Registration Date : 2023-10-17

    Registration Number : No. 163-32-ND(A)

    Manufacturer Name : MSN Laboratories Private Limit...

    Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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    10

    Baricitinib

    India
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    Baricitinib

    India
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    MSN Laboratories

    Registrant Name : Agerson Bio Co., Ltd.

    Registration Date : 2024-04-03

    Registration Number : 163-32-ND(C)

    Manufacturer Name : MSN Laboratories Private Limit...

    Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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    FDF Dossiers

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    01

    Brand Name : ABIRATERONE ACETATE

    India
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    Brand Name : ABIRATERONE ACETATE

    India
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    Regulatory Info : RX

    Registration Country : USA

    ABIRATERONE ACETATE

    MSN Laboratories

    Dosage Form : TABLET;ORAL

    Brand Name : ABIRATERONE ACETATE

    Dosage Strength : 250MG

    Packaging :

    Approval Date : 2019-07-10

    Application Number : 210686

    Regulatory Info : RX

    Registration Country : USA

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    Brand Name : ABIRATERONE ACETATE

    India
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    Brand Name : ABIRATERONE ACETATE

    India
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    Regulatory Info : RX

    Registration Country : USA

    ABIRATERONE ACETATE

    MSN Laboratories

    Dosage Form : TABLET;ORAL

    Brand Name : ABIRATERONE ACETATE

    Dosage Strength : 500MG

    Packaging :

    Approval Date : 2024-04-24

    Application Number : 210686

    Regulatory Info : RX

    Registration Country : USA

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    03

    Brand Name : ACYCLOVIR

    India
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    Brand Name : ACYCLOVIR

    India
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    Regulatory Info : RX

    Registration Country : USA

    ACYCLOVIR

    MSN Laboratories

    Dosage Form : SUSPENSION;ORAL

    Brand Name : ACYCLOVIR

    Dosage Strength : 200MG/5ML

    Packaging :

    Approval Date : 2023-03-09

    Application Number : 217393

    Regulatory Info : RX

    Registration Country : USA

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    Brand Name : AFATINIB

    India
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    Brand Name : AFATINIB

    India
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    Regulatory Info :

    Registration Country : USA

    AFATINIB

    MSN Laboratories

    Dosage Form : TABLET;ORAL

    Brand Name : AFATINIB

    Dosage Strength : 20MG

    Packaging :

    Approval Date :

    Application Number : 210804

    Regulatory Info :

    Registration Country : USA

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    Brand Name : AFATINIB

    India
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    Brand Name : AFATINIB

    India
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    Regulatory Info :

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    AFATINIB

    MSN Laboratories

    Dosage Form : TABLET;ORAL

    Brand Name : AFATINIB

    Dosage Strength : 40MG

    Packaging :

    Approval Date :

    Application Number : 210804

    Regulatory Info :

    Registration Country : USA

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    Brand Name : AFATINIB

    India
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    Brand Name : AFATINIB

    India
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    Regulatory Info :

    Registration Country : USA

    AFATINIB

    MSN Laboratories

    Dosage Form : TABLET;ORAL

    Brand Name : AFATINIB

    Dosage Strength : 30MG

    Packaging :

    Approval Date :

    Application Number : 210804

    Regulatory Info :

    Registration Country : USA

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    Brand Name : ALBENDAZOLE

    India
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    Brand Name : ALBENDAZOLE

    India
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    Regulatory Info : RX

    Registration Country : USA

    ALBENDAZOLE

    MSN Laboratories

    Dosage Form : TABLET;ORAL

    Brand Name : ALBENDAZOLE

    Dosage Strength : 200MG

    Packaging :

    Approval Date : 2021-01-21

    Application Number : 213435

    Regulatory Info : RX

    Registration Country : USA

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    Brand Name : ALOGLIPTIN AND METFO...

    India
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    Brand Name : ALOGLIPTIN AND METFO...

    India
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    Regulatory Info :

    Registration Country : USA

    ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

    MSN Laboratories

    Dosage Form : TABLET; ORAL

    Brand Name : ALOGLIPTIN AND METFORMIN ...

    Dosage Strength : 12.5MG/500MG

    Packaging :

    Approval Date :

    Application Number : 210212

    Regulatory Info :

    Registration Country : USA

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    Brand Name : ALOGLIPTIN AND METFO...

    India
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    Brand Name : ALOGLIPTIN AND METFO...

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    ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

    MSN Laboratories

    Dosage Form : TABLET; ORAL

    Brand Name : ALOGLIPTIN AND METFORMIN ...

    Dosage Strength : 12.5MG/1000MG

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    Approval Date :

    Application Number : 210212

    Regulatory Info :

    Registration Country : USA

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    Brand Name : ALOGLIPTIN

    India
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    Brand Name : ALOGLIPTIN

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    Regulatory Info :

    Registration Country : USA

    ALOGLIPTIN BENZOATE

    MSN Laboratories

    Dosage Form : TABLET;ORAL

    Brand Name : ALOGLIPTIN

    Dosage Strength : EQ 12.5MG BASE

    Packaging :

    Approval Date :

    Application Number : 210213

    Regulatory Info :

    Registration Country : USA

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    FDA

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    01

    FDA Audited

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    FDA Audited

    USA
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    Biotech Digital Meet
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    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
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    FDA Audited

    USA
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    Biotech Digital Meet
    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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    03

    FDA Audited

    USA
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    FDA Audited

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    Biotech Digital Meet
    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
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    FDA Audited

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    Biotech Digital Meet
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    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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    05

    FDA Audited

    USA
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    FDA Audited

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    Biotech Digital Meet
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    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
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    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
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    FDA Audited

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    Biotech Digital Meet
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    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
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    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

    USA
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    FDA Audited

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    Biotech Digital Meet
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    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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    10

    FDA Audited

    USA
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    FDA Audited

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    Biotech Digital Meet
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    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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    GMP Certified

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    MSN Laboratories

    Type : GMP Certificates

    Number : 450-4/2014-...

    EudraGMDP Key : 23822

    Country : India

    Issue Date :

    Post Code : 508126

    NCA Ref : 2.3822139403...

    City : Nalgonda District

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