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    Company profile for MSN Laboratories

    Trusted Global CDMO Partner Delivering End-to-End Pharma Manufacturing & Development Solutions.

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

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    Topscience Biotech specializes in R&D, production, and sales of Sodium Hyaluronate, focusing on Medical and Pharmaceutical Grade HA.

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    With Virupaksha, you get a quality product with on-time delivery.

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    LEBSA- Your strategic API source for niche molecules.

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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]
    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets 

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    Radio Compass
    12 Mar 2025
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    VLOG #PharmaReel

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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Molecular glue degraders: Lilly, AbbVie sign billion-dollar deals; BMS leads with three late-stage drugs

    Molecular glue degraders: Lilly, AbbVie sign billion-dollar deals; BMS leads with three late-stage drugs

    This week, we delve into molecular glue degraders (MGDs), one of the most promising frontiers in drug development. MGDs address a vast number of previously “undruggable” disease-causing proteins.Unlike traditional small molecule drugs that require specific binding pockets, MGDs function by enhancing protein-protein interactions. MGDs selectively target disease-causing proteins and an enzyme known as E3 ubiquitin ligase. By creating a binding interface between the two, MGDs  destroy the target proteins.Another kind of degraders are proteolysis targeting chimeras (PROTACs) that use a bifunctional approach — one binds the target proteins, and the other binds to an E3 ligases together. These degraders induce the degradation of specific proteins by using the cell’s natural ubiquitin-proteasome system (a process in cells where damaged or unneeded proteins are tagged by a small molecule called ubiquitin and then broken down by a structure called the proteasome so that cells stay healthy and function properly).MGDs constitute a rapidly growing market, where both the targeted protein degradation technologies and investment in research and development are witnessing growth.Currently, the most recognized molecular glues are the immunomodulatory imide drugs (IMiDs), such as thalidomide, lenalidomide and pomalidomide, which have been around for some time. According to GlobalData, lenalidomide generated over US$ 6 billion in sales in 2023, thereby demonstrating the commercial viability of this therapeutic approach.Lilly, AbbVie ink billion-dollar MGD deals; Biogen partners Neomorph; Pfizer, Triana ink collaborationThe MGD space has witnessed extraordinary deal-making activity over the recent months, with major pharmaceutical companies committing billions of dollars to secure access to novel MGD platforms and pipelines. This surge in investment reflects the industry’s growing confidence in the therapeutic potential of MGDs to address previously undruggable targets.This year has already seen two landmark deals. In February, Magnet Biomedicine entered into a collaboration and license agreement with Eli Lilly worth up to US$ 1.29 billion to discover and develop novel MGDs. This partnership leverages Magnet’s TrueGlue discovery platform and approach with Lilly’s expertise in the development of small molecule therapeutics. In January, AbbVie crafted a US$ 1.64 billion deal with molecular glue biotech Neomorph, combining AbbVie’s oncology and immunology drug development capabilities with Neomorph's leading molecular glue discovery platform.While oncology remains the primary focus, these collaborations are increasingly expanding into neurodegenerative diseases, immunological disorders, and other therapeutic areas. For instance, in October, Biogen and Neomorph announced a multi-target research collaboration to discover and develop MGDs for Alzheimer’s, rare neurological, and immunological diseases, potentially worth up to US$ 1.45 billion.October also saw Novartis sign a potential US$ 2.25 billion deal with Monte Rosa Therapeutics. The deal gives Novartis exclusive worldwide rights to develop, manufacture and commercialize multiple MGDs (including MRT-6160) for undruggable targets, including in the areas of immunology and inflammation, metabolism, and genetic diseases.Earlier in October, Triana Biomedicines and Pfizer entered into a research collaboration to discover novel MGDs for multiple targets across several disease areas, including oncology, with a total potential value of up to US$ 1.55 billion.And in August 2024, SEED Therapeutics entered into a strategic research collaboration with Eisai to discover and develop novel MGDs for neurodegenerative and oncological indications, potentially worth up to US$ 1.5 billion.BMS leads with three MGDs in late-stage trials; Monte Rosa’s MRT-2359 targets solid tumorsBristol Myers Squibb has established itself as a leader in the clinical development of MGDs with three products in late-stage development. These include a next-gen MGD mezigdomide (CC-92480), which is currently in phase 3 trials in combination with carfilzomib and dexamethasone for relapsed/refractory multiple myeloma. Another candidate is golcadomide, which is in late-stage clinical trials for high-risk first-line large B-cell lymphoma. And the third MGD in BMS’ portfolio is iberdomide, which has reached phase 3 development for multiple myeloma.Monte Rosa Therapeutics has made significant progress with MRT-2359, an investigational MGD that is currently in phase 1/2 clinical trials for the treatment of patients with MYC-driven solid tumors, including non-small cell lung cancer, small cell lung cancer, and high-grade neuroendocrine cancer. Myelocytomatosis or MYC is a gene which causes various solid tumors when overactive.MRT-2359 represents an important advancement in extending the molecular glue approach beyond hematological malignancies to solid tumors, which have historically proven more challenging to address with protein degradation strategies.Other significant early-stage candidates are Nested Therapeutics’ NST-628 and Plexium's PLX-4545. NST-628 relies on a novel mechanism of action in its category of RAS-MAPK inhibitors, and overcomes some traditional limitations in the treatment of cancers.PLX-4545 is Plexium’s first small molecule degrader program to enter clinical development. This potent and selective MGD of a classically undruggable transcription factor, also known as Helios (IKZF2), explores treating solid tumors. Transcription factors are proteins that regulate gene expression by binding to specific DNA sequences.Boehringer’s KRAS degrader advances PROTACs approach; Arvinas tests ARV-102 for neurodegenerative diseasesLike MGDs, PROTACs are also witnessing advancements in both R&D and dealmaking. For instance, BridGene Biosciences recently expanded its strategic collaboration with Galapagos to develop a selective oral SMARCA2 PROTAC in precision oncology. The SMARCA2 gene provides instructions for making one piece (subunit) of a group of similar protein complexes known as SWI/SNF complexes.In the clinical arena, Prelude Therapeutics announced a collaboration with Merck to evaluate PRT3789 in combination with Keytruda (pembrolizumab) in patients with SMARCA4-mutated cancers. PRT3789 is a potent and highly selective, first-in-class SMARCA2 degrader.On the molecular front, ACBI3, a novel pan-KRAS degrader developed through a collaboration between the University of Dundee and Boehringer Ingelheim, addresses a critical gap in cancer therapy by targeting 13 out of 17 prevalent KRAS mutants. KRAS mutation is a change in the KRAS gene, a common gene that can cause cancer. ACBI3’s development is a potential breakthrough for millions of cancer patients with KRAS-driven tumors.Vepdegestrant (ARV-471), a collaborative effort between Arvinas and Pfizer, remains the most advanced PROTAC candidate to date and has met its primary endpoint in a late-stage study in breast cancer patients with estrogen receptor 1 mutations.  Similarly, Arvinas’ ARV-102 became the first PROTAC to be tested in humans for neurodegenerative diseases, marking a significant milestone in addressing brain-related disorders.Our viewMGDs offer a new, and groundbreaking approach to treating cancers and various other diseases, thereby attracting substantial investments by major pharmaceutical companies. As clinical trials show encouraging results, we expect investments in the MGDs space to increase even further. 
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    https://www.pharmacompass.com/radio-compass-blog/molecular-glue-degraders-lilly-abbvie-sign-billion-dollar-deals-bms-leads-with-three-late-stage-drugs

    #Phispers by PHARMACOMPASS
    27 Mar 2025
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    NEWS #PharmaBuzz

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    MSN`s Generics Lofexidine HCl Receives Approval in US
    MSN`s Generics Lofexidine HCl Receives Approval in US

    24 Feb 2025

    // FDA

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

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

    24 Feb 2025

    // FDA

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

    FDA
    24 Feb 2025
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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
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    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
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    ALL APIs

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    01

    Duloxetine Hydrochloride

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

    Peptide Therapy Summit
    Not Confirmed
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    Duloxetine Hydrochloride

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-11-17

    Pay. Date : 2020-11-10

    DMF Number : 20996

    Submission : 2007-10-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-368 - Rev 01

    Issue Date : 2024-07-03

    Type : Chemical

    Substance Number : 2594

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10088

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

    Initial Date of Registration : 2017-04-26

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0021n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 14501-0005

    Start Marketing Date : 2010-03-24

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2012-04-13

    Registration Number : Su342-8-ND

    Manufacturer Name : MSN Laboratories PVT LTD

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

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    02

    Lacosamide

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

    Peptide Therapy Summit
    Not Confirmed
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    Lacosamide

    India

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

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    Peptide Therapy Summit
    Not Confirmed
    • fda
    • EDQM
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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
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-04

    Pay. Date : 2012-11-20

    DMF Number : 26270

    Submission : 2012-07-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-060 - Rev 04

    Issue Date : 2024-07-19

    Type : Chemical

    Substance Number : 2992

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10101

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

    Initial Date of Registration : 2024-07-17

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2019-08-16

    Valid Till : 2025-08-15

    Written Confirmation Number : WC-0022

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 50370-0024

    Start Marketing Date : 2011-12-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2016-03-25

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

    Manufacturer Name : MSN Pharmachem Private Limited

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

     VMF Others AUDIT
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    03

    Oseltamivir Phosphate

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

    Peptide Therapy Summit
    Not Confirmed
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    Oseltamivir Phosphate

    India

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

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    Peptide Therapy Summit
    Not Confirmed
    • fda
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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
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-05-16

    Pay. Date : 2014-04-25

    DMF Number : 23889

    Submission : 2010-06-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-067 - Rev 02

    Issue Date : 2023-10-24

    Type : Chemical

    Substance Number : 2422

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10042

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

    Initial Date of Registration : 2017-02-15

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2019-08-16

    Valid Till : 2025-08-15

    Written Confirmation Number : WC-0022

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 69766-092

    Start Marketing Date : 2020-12-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2019-08-06

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

    Manufacturer Name : MSN Pharmachem Private Limited

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

     VMF Others AUDIT
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    04

    Voriconazole

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

    Peptide Therapy Summit
    Not Confirmed
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    Voriconazole

    India

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

    arrow
    Peptide Therapy Summit
    Not Confirmed
    • fda
    • EDQM
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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
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-21

    Pay. Date : 2013-09-11

    DMF Number : 21523

    Submission : 2008-04-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

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

    Issue Date : 2023-06-29

    Type : Chemical

    Substance Number : 2576

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10097

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

    Initial Date of Registration : 2018-08-02

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0021n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 70600-045

    Start Marketing Date : 2023-03-15

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    05

    Dutasteride

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

    Peptide Therapy Summit
    Not Confirmed
    arrow

    Dutasteride

    India

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

    arrow
    Peptide Therapy Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-09

    Pay. Date : 2012-12-06

    DMF Number : 23533

    Submission : 2010-02-16

    Status : Active

    Type : II

     CEP/COS 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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : 아이엠씨디코리아주식회사

    Registration Date : 2020-08-20

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

    Manufacturer Name : MSN Laboratories Private Limited

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

     VMF Others AUDIT
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    Market
    Place

    06

    Pioglitazone Hydrochloride

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

    Peptide Therapy Summit
    Not Confirmed
    arrow

    Pioglitazone Hydrochloride

    India

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

    arrow
    Peptide Therapy Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-17

    Pay. Date : 2017-02-27

    DMF Number : 24181

    Submission : 2010-09-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

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

    Issue Date : 2019-02-20

    Type : Chemical

    Substance Number : 2601

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10024

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

    Initial Date of Registration : 2019-06-28

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2020-04-15

    Valid Till : 2023-05-19

    Written Confirmation Number : WC-0281new2

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 50379-0008

    Start Marketing Date : 2012-07-03

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : (주)에스지바이오켐

    Registration Date : 2024-12-11

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

    Manufacturer Name : MSN Organics Private Limited

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

     VMF Others AUDIT
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    Place

    07

    Alfuzosin HCl

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

    Peptide Therapy Summit
    Not Confirmed
    arrow

    Alfuzosin HCl

    India

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

    arrow
    Peptide Therapy Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20867

    Submission : 2007-09-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2006-208 - Rev 06

    Issue Date : 2024-01-31

    Type : Chemical

    Substance Number : 1287

    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 : 14501-0003

    Start Marketing Date : 2010-03-22

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    08

    Moxifloxacin Hydrochloride

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

    Peptide Therapy Summit
    Not Confirmed
    arrow

    Moxifloxacin Hydrochloride

    India

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

    arrow
    Peptide Therapy Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2021-02-25

    Registration Number : 20210225-209-J-841

    Manufacturer Name : MSN Pharmachem Private Limited

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

     VMF Others AUDIT
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    Market
    Place

    09

    Pantoprazole Sodium

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

    Peptide Therapy Summit
    Not Confirmed
    arrow

    Pantoprazole Sodium

    India

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

    arrow
    Peptide Therapy Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    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 : R1-CEP 2010-060 - Rev 02

    Issue Date : 2023-01-18

    Type : Chemical

    Substance Number : 2296

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-17

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0021n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 72640-008

    Start Marketing Date : 2019-09-09

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
    Place

    10

    Rosuvastatin Calcium

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

    Peptide Therapy Summit
    Not Confirmed
    arrow

    Rosuvastatin Calcium

    India

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

    arrow
    Peptide Therapy Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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 : 72640-013

    Start Marketing Date : 2020-01-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : JSP Co., Ltd.

    Registration Date : 2023-03-23

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

    Manufacturer Name : MSN Laboratories Private Limited

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

     VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    "clopidogrel Bisulfate Usp"

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    02

    "levothyroxine Sodium Usp"

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    03

    "tenofovir Alafenamide Monofumarate"

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    04

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

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    05

    Abaloparatide

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    06

    Abemaciclib

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    07

    Abemaciclib

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    08

    Abiraterone

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    09

    Abiraterone Acetate Usp

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    10

    Abiraterone Acetate Usp [route Code ...

    India
    Peptide Therapy Summit
    Not Confirmed
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    EU WC

    read-more
    read-more

    01

    Abemaciclib IH

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    02

    Abiraterone IH/Abiraterone A...

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    03

    Abiraterone IH

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    04

    Acalabrutinib IH

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    05

    Aclidinium Bromide IH

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    06

    Afatinib Dimaleate IHS

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    07

    Agomelatine (IH)

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    08

    Albendazole USP/EP

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    09

    Alcaftadine IH

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow

    10

    Alcaftadine IH

    India
    Peptide Therapy Summit
    Not Confirmed
    arrow
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    Drugs in Development

    read-more
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    Breast Cancer Treatment Made More Affordable & Accessible with Launch of World’s First Branded Generic Palbociclib Tablets (Palborest) 75/100/125mg by...

    Details:

    Palborest (palbociclib) is a piperazine pyridopyrimidine3, second generation cyclin-dependent kinase inhibitor. Approved in combination with hormonal therapies for hormone receptor positive, human epidermal growth factor receptor negative breast cancer.


    Lead Product(s): Palbociclib

    Therapeutic Area: Oncology Brand Name: Palborest

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 17, 2023

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    01

    MSN Laboratories

    India
    arrow
    Peptide Therapy Summit
    Not Confirmed

    MSN Laboratories

    India
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    Peptide Therapy Summit
    Not Confirmed
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    Lead Product(s) : Palbociclib

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Breast Cancer Treatment Made More Affordable & Accessible with Launch of World’s First Branded G...

    Details : Palborest (palbociclib) is a piperazine pyridopyrimidine3, second generation cyclin-dependent kinase inhibitor. Approved in combination with hormonal therapies for hormone receptor positive, human epidermal growth factor receptor negative breast cancer.

    Product Name : Palborest

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 17, 2023

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    Breckenridge Pharmaceutical, Inc. Announces Launch of Lacosamide Tablets, USP (generic version of Vimpat®) Manufactured by MSN Laboratories Private Lim...

    Details:

    Lacosamide Tablets, USP (generic version of Vimpat), indicated for the prevention and control of seizures, enhances the slow inactivation of voltage-gated sodium channels without affecting the fast inactivation of voltage-gated sodium channels.


    Lead Product(s): Lacosamide

    Therapeutic Area: Neurology Brand Name: Lacosamide-Generic

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Breckenridge Pharmaceutical

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 19, 2022

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    02

    MSN Laboratories

    India
    arrow
    Peptide Therapy Summit
    Not Confirmed

    MSN Laboratories

    India
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    Peptide Therapy Summit
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    Lead Product(s) : Lacosamide

    Therapeutic Area : Neurology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Breckenridge Pharmaceutical

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Breckenridge Pharmaceutical, Inc. Announces Launch of Lacosamide Tablets, USP (generic version of ...

    Details : Lacosamide Tablets, USP (generic version of Vimpat), indicated for the prevention and control of seizures, enhances the slow inactivation of voltage-gated sodium channels without affecting the fast inactivation of voltage-gated sodium channels.

    Product Name : Lacosamide-Generic

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    April 19, 2022

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    MSN Laboratories Gets CDSCO Panel Nod For FDCs Solifenacin, Mirabegron Capsules

    Details:

    Solifenacin succinatei immediate release tablet is a muscarinic receptor antagonist and Mirabegron capsule is a potent and selective β3-adrenoceptor agonist, indicated for the treatment of overactive bladder.


    Lead Product(s): Solifenacin Succinate,Mirabegron

    Therapeutic Area: Urology Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 30, 2022

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    03

    MSN Laboratories

    India
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    Peptide Therapy Summit
    Not Confirmed

    MSN Laboratories

    India
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    Lead Product(s) : Solifenacin Succinate,Mirabegron

    Therapeutic Area : Urology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    MSN Laboratories Gets CDSCO Panel Nod For FDCs Solifenacin, Mirabegron Capsules

    Details : Solifenacin succinatei immediate release tablet is a muscarinic receptor antagonist and Mirabegron capsule is a potent and selective β3-adrenoceptor agonist, indicated for the treatment of overactive bladder.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 30, 2022

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    MSN Lab Begins Phase III Clinical Trial of Molnupiravir Capsules for Covid Treatment in India

    Details:

    Molnupiravir is an experimental drug having antiviral properties and is currently under clinical-stage study for COVID treatment.


    Lead Product(s): Molnupiravir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 25, 2021

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    04

    MSN Laboratories

    India
    arrow
    Peptide Therapy Summit
    Not Confirmed

    MSN Laboratories

    India
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    Lead Product(s) : Molnupiravir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    MSN Lab Begins Phase III Clinical Trial of Molnupiravir Capsules for Covid Treatment in India

    Details : Molnupiravir is an experimental drug having antiviral properties and is currently under clinical-stage study for COVID treatment.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    May 25, 2021

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    MSN Labs Launch Indigenous Drug Posaconazole to Treat Black Fungus

    Details:

    Posaconazole has been launched under the brand name PosaOne as 100 mg Delayed Release tablets and 300 mg injections, respectively. The drug has also been approved by the Drug Controller General of India (DGCI).


    Lead Product(s): Posaconazole

    Therapeutic Area: Infections and Infectious Diseases Brand Name: PosaOne

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 22, 2021

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    05

    MSN Laboratories

    India
    arrow
    Peptide Therapy Summit
    Not Confirmed

    MSN Laboratories

    India
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    Peptide Therapy Summit
    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Posaconazole

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    MSN Labs Launch Indigenous Drug Posaconazole to Treat Black Fungus

    Details : Posaconazole has been launched under the brand name PosaOne as 100 mg Delayed Release tablets and 300 mg injections, respectively. The drug has also been approved by the Drug Controller General of India (DGCI).

    Product Name : PosaOne

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    May 22, 2021

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    MSN Labs Launches Generic Cangrelor, a New Drug for PCI To Reduce Risk of MI

    Details:

    Company rolled out the first generic version of Cangrelor is an intravenous platelet P2Y12 antagonist ) used to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis.


    Lead Product(s): Cangrelor

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 10, 2021

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    Lead Product(s) : Cangrelor

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    MSN Labs Launches Generic Cangrelor, a New Drug for PCI To Reduce Risk of MI

    Details : Company rolled out the first generic version of Cangrelor is an intravenous platelet P2Y12 antagonist ) used to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis.

    Product Name : Undisclosed

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 10, 2021

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