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    Company profile for Amoli Organics

    Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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    Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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    xyz-pharma-m-2024-10-07

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    Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

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    Aspen API. More than just an API.

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    EVENTS

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    About

    Amoli is the vision and perseverance of its founder, Mr. Umed Doshi a widely respected entrepreneur. Amoli has a successful track record in the pharmaceutical and allied industry. Making a beginning as a manufacturer of API’s and Intermediates, it made successful forays in the field of ‘Contract Research’ and ‘Custom Synthesis’. Amoli has been working collaboratively with some of the leading global healthcare player...
    Amoli is the vision and perseverance of its founder, Mr. Umed Doshi a widely respected entrepreneur. Amoli has a successful track record in the pharmaceutical and allied industry. Making a beginning as a manufacturer of API’s and Intermediates, it made successful forays in the field of ‘Contract Research’ and ‘Custom Synthesis’. Amoli has been working collaboratively with some of the leading global healthcare players. Our Strength: 1100 strong dedicated work force, 2 state-of the art manufacturing Sites, Sites are CGMP and SHE compliant, Well equipped R&D centre (Process Development),Custom Synthesis and Contract Manufacturing, etc

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    CONTACT DETAILS

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    Amoli Organicsindia-flag Flag
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    India
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    407, Dalamal House, Jamnalal Bajaj Road, Nariman Point, Mumbai - 400 021, Maha...
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    +91-22-6621 4715
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    Email
    enquiries@pharmacompass.com
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    Website
    https://www.amoliindia.com/
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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  

    Impressions: 4607

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

    Radio Compass
    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025. 
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    Impressions: 421

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-bora-polpharma-make-acquisitions-evonik-euroapi-porton-announce-technological-expansions

    #PharmaFlow by PHARMACOMPASS
    19 Dec 2024
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    ALL APIs

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    01

    Venlafaxine Hydrochloride

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Venlafaxine Hydrochloride

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    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 : 2019-11-14

    Pay. Date : 2019-11-08

    DMF Number : 21439

    Submission : 2008-03-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-092 - Rev 01

    Issue Date : 2019-12-06

    Type : Chemical

    Substance Number : 2119

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 306MF10043

    Registrant's Address : 407, Dalamal House, Jamnalal Bajaj Road, Nariman Point, Mumbai-400021. India.

    Initial Date of Registration : 2024-03-13

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-24

    Valid Till : 2025-08-12

    Written Confirmation Number : WC-0077A5-6

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62512-0055

    Start Marketing Date : 1997-10-20

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT
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    02

    Carbamazepine

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Carbamazepine

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-27

    Pay. Date : 2013-01-15

    DMF Number : 23170

    Submission : 2009-10-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-129 - Rev 01

    Issue Date : 2023-10-26

    Type : Chemical

    Substance Number : 543

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10157

    Registrant's Address : 407, Dalamal House, Jamnalal Bajaj Road, Nariman Point, Mumbai-400021. India.

    Initial Date of Registration : 2018-11-16

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-08-13

    Valid Till : 2022-08-12

    Written Confirmation Number : WC-0077

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62512-0024

    Start Marketing Date : 2013-11-25

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    03

    Atorvastatin

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Atorvastatin

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-08-07

    Pay. Date : 2019-06-25

    DMF Number : 25346

    Submission : 2011-11-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-206 - Rev 02

    Issue Date : 2023-03-23

    Type : Chemical

    Substance Number : 2191

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-24

    Valid Till : 2025-08-12

    Written Confirmation Number : WC-0077A5-6

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62512-0022

    Start Marketing Date : 2015-03-07

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    04

    Diclofenac Sodium

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Diclofenac Sodium

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11676

    Submission : 1995-09-26

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1997-066 - Rev 04

    Issue Date : 2021-06-01

    Type : Chemical

    Substance Number : 1002

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10010

    Registrant's Address : 407, Dalamal House, Jamnalal Bajaj Road, Nariman Point, Mumbai-400021. India

    Initial Date of Registration : 2006-01-27

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2016-06-23

    Valid Till : 2019-07-02

    Written Confirmation Number : WC-0134

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62512-0012

    Start Marketing Date : 1991-03-28

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Masung LS Co., Ltd.

    Registration Date : 2023-10-24

    Registration Number : 20111111-80-D-108-12(A)

    Manufacturer Name : Amoli Organics Pvt. Ltd

    Manufacturer Address : Plot No. 322/4, 40 Shed Area, GIDC, Vapi-396195, Gujarat State, India

     VMF Others AUDIT
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    05

    Tadalafil

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Tadalafil

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-03-20

    Pay. Date : 2016-08-19

    DMF Number : 30608

    Submission : 2016-06-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-183 - Rev 01

    Issue Date : 2024-01-11

    Type : Chemical

    Substance Number : 2606

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-29

    Valid Till : 2025-08-12

    Written Confirmation Number : WC-0077A8

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62512-0056

    Start Marketing Date : 2017-11-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Celecoxib

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Celecoxib

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-02

    Pay. Date : 2016-08-19

    DMF Number : 25427

    Submission : 2012-01-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-200 - Rev 00

    Issue Date : 2024-08-14

    Type : Chemical

    Substance Number : 2591

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-08-13

    Valid Till : 2022-08-12

    Written Confirmation Number : WC-0077

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62512-0018

    Start Marketing Date : 2015-05-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : M-Peak Korea Co., Ltd.

    Registration Date : 2021-06-23

    Registration Number : 20210623-209-J-846

    Manufacturer Name : Amoli Organics Pvt. Ltd

    Manufacturer Address : Block No. 422, ECP Canal Road, Village-Luna, Taluka-Padra, District-Vadodara, PIN-391 440 State-Gujarat, INDIA

     VMF Others AUDIT
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    07

    Clotrimazole

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Clotrimazole

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
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    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-09-17

    Pay. Date : 2016-03-16

    DMF Number : 26483

    Submission : 2012-10-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-009 - Rev 01

    Issue Date : 2019-10-07

    Type : Chemical

    Substance Number : 757

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2016-06-23

    Valid Till : 2019-07-02

    Written Confirmation Number : WC-0134

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62512-0044

    Start Marketing Date : 2010-09-02

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    08

    Diclofenac Potassium

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Diclofenac Potassium

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-10-27

    Pay. Date : 2017-10-16

    DMF Number : 23028

    Submission : 2009-08-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-144 - Rev 01

    Issue Date : 2022-06-17

    Type : Chemical

    Substance Number : 1508

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2016-06-23

    Valid Till : 2019-07-02

    Written Confirmation Number : WC-0134

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62512-0048

    Start Marketing Date : 1998-08-06

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF Others AUDIT
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    09

    Hydrochlorothiazide

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Hydrochlorothiazide

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-05-09

    Pay. Date : 2015-11-20

    DMF Number : 25849

    Submission : 2012-03-13

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-362 - Rev 00

    Issue Date : 2024-11-18

    Type : Chemical

    Substance Number : 394

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2020-03-09

    Valid Till : 2022-08-12

    Written Confirmation Number : WC-0077A3

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62512-0028

    Start Marketing Date : 2013-12-04

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    blank

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    10

    Olmesartan Medoxomil

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

    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Olmesartan Medoxomil

    India

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

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

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-06-11

    Pay. Date : 2014-05-19

    DMF Number : 27164

    Submission : 2013-05-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-404 - Rev 01

    Issue Date : 2023-02-22

    Type : Chemical

    Substance Number : 2600

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-08-13

    Valid Till : 2022-08-12

    Written Confirmation Number : WC-0077

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62512-0034

    Start Marketing Date : 2004-05-25

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    Apixaban

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Apixaban

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Amoli Organics

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-12-26

    Pay. Date : 2023-09-28

    DMF Number : 38900

    Submission : 2023-09-23

    Status : Active

    Type : II

    blank

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    Market
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    02

    Aripiprazole Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    03

    Ascorbic Acid Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    04

    Atorvastatin Calcium Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    05

    Carbamazepine Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Carbamazepine Usp

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Amoli Organics

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-09-27

    Pay. Date : 2013-01-15

    DMF Number : 23170

    Submission : 2009-10-14

    Status : Active

    Type : II

    blank

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    Stock Recap
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    Market
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    06

    Celecoxib Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Celecoxib Usp

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Amoli Organics

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-03-02

    Pay. Date : 2016-08-19

    DMF Number : 25427

    Submission : 2012-01-03

    Status : Active

    Type : II

    blank

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    Market
    Place

    07

    Chlorthalidone Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    08

    Chlorthalidone Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Chlorthalidone Usp

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Amoli Organics

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-03-22

    Pay. Date : 2016-08-19

    DMF Number : 30551

    Submission : 2016-05-24

    Status : Active

    Type : II

    blank

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    Market
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    09

    Clotrimazole Usp

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow

    Clotrimazole Usp

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Amoli Organics

    GDUFA

    DMF Review : Complete

    Rev. Date : 2020-09-17

    Pay. Date : 2016-03-16

    DMF Number : 26483

    Submission : 2012-10-12

    Status : Active

    Type : II

    blank

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    Place

    10

    Dapagliflozin Amorphous

    India
    Pharma, Lab & Chemical Expo
    Not Confirmed
    arrow
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    Contact Amoli Organics and get a quotation

    Amoli Organics is a supplier offers 63 products (APIs, Excipients or Intermediates).

    Find a price of Venlafaxine Hydrochloride bulk with DMF, CEP, JDMF, WC offered by Amoli Organics

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    Find a price of Diclofenac Potassium bulk with DMF, CEP offered by Amoli Organics

    Find a price of Hydrochlorothiazide bulk with DMF, CEP offered by Amoli Organics

    Find a price of Olmesartan Medoxomil bulk with DMF, CEP offered by Amoli Organics

    Find a price of Oxcarbazepine bulk with DMF, CEP offered by Amoli Organics

    Find a price of Pirfenidone bulk with DMF, CEP offered by Amoli Organics

    Find a price of Sertraline Hydrochloride bulk with DMF, CEP offered by Amoli Organics

    Find a price of Solifenacin Succinate bulk with DMF, CEP offered by Amoli Organics

    Find a price of Venlafaxine Hydrochloride bulk with DMF, CEP offered by Amoli Organics

    Find a price of Ascorbic Acid bulk with DMF, WC offered by Amoli Organics

    Find a price of Deferasirox bulk with DMF, CEP offered by Amoli Organics

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    Find a price of Mesalazine bulk with DMF, CEP offered by Amoli Organics

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    Find a price of Rivaroxaban bulk with DMF, CEP offered by Amoli Organics

    Find a price of Rosuvastatin Calcium bulk with CEP offered by Amoli Organics

    Find a price of Sildenafil Citrate bulk with CEP offered by Amoli Organics

    Find a price of Aceclofenac bulk with CEP offered by Amoli Organics

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    Find a price of Dihydralazine Sulfate bulk with CEP offered by Amoli Organics

    Find a price of Dimethyl Fumarate bulk with DMF offered by Amoli Organics

    Find a price of Hydrochlorothiazide bulk with CEP offered by Amoli Organics

    Find a price of Linezolid bulk with WC offered by Amoli Organics

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    Find a price of Aripiprazole bulk offered by Amoli Organics

    Find a price of Carbamazepine bulk with CEP offered by Amoli Organics

    Find a price of Celecoxib bulk with CEP offered by Amoli Organics

    Find a price of Chlorthalidone bulk with DMF offered by Amoli Organics

    Find a price of Chlorthalidone bulk offered by Amoli Organics

    Find a price of Dapagliflozin bulk with DMF offered by Amoli Organics

    Find a price of Desvenlafaxine Succinate bulk with DMF offered by Amoli Organics

    Find a price of Diclofenac Epolamine bulk with DMF offered by Amoli Organics

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    Find a price of Dihydralazine Mesylate bulk with WC offered by Amoli Organics

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    Find a price of Linezolid bulk offered by Amoli Organics

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    Find a price of Olmesartan Medoxomil bulk with CEP offered by Amoli Organics

    Find a price of Sacubitril-Valsartan bulk with DMF offered by Amoli Organics

    Find a price of Sildenafil Citrate bulk with DMF offered by Amoli Organics

    Find a price of Sitagliptin Phosphate bulk with DMF offered by Amoli Organics

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    Find a price of Telmisartan bulk offered by Amoli Organics

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    Find a price of CAS 144689-63-4 bulk offered by Amoli Organics

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    Find a price of Oxcarbazepine bulk offered by Amoli Organics

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    Find a price of Sodium Ascorbate bulk offered by Amoli Organics

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    Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GUJARAT, INDIA. bulk offered by Amoli Organics

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