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    Company profile for Cipla

    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

    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we...
    Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.

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    Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumba...
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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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    https://www.pharmacompass.com/speak-pharma/our-unmatched-efficiency-and-track-record-of-faster-dmf-filings-give-our-customers-a-critical-competitive-advantage

    Radio Compass
    12 Mar 2025
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    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    CDMO Activity Tracker: Axplora enhances ADC capacities, Quotient beefs up HPAPI capabilities; Evonik, EUROAPI forge deals

    CDMO Activity Tracker: Axplora enhances ADC capacities, Quotient beefs up HPAPI capabilities; Evonik, EUROAPI forge deals

    The contract development and manufacturing organization (CDMO) sector witnessed significant activity in the first quarter (Q1) of 2025, characterized by strategic investments, facility expansions, and collaborative partnerships.The quarter saw some significant deals. WuXi Biologics agreed to sell its vaccine manufacturing facility in Dundalk, Ireland, to Merck for € 500 million (US$  521 million). Quadria Capital announced the acquisition of a 10 percent stake in Aragen for US$ 100 million. This investment will help Aragen accelerate its research and development efforts.Some CDMOs, like India-based Syngene International and Belgium-based Ardena expanded their presence in the US market. Syngene completed the acquisition of its first US biologics facility that it had purchased from Emergent Manufacturing Operations Baltimore for US$ 36.5 million. And, leading nanomedicine developer Ardena purchased a drug manufacturing unit in New Jersey from Catalent.  View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Axplora expands its ADC capacities; Quotient Sciences wraps up HPAPI unit upgradeThe antibody-drug conjugate (ADC) market saw considerable investments by CDMOs. Axplora expanded its commercial payload production capabilities at its Le Mans site in France, reinforcing its position as a leading player in ADC manufacturing. This expansion is part of the France 2030 program and builds on Axplora’s track record of supplying 40 percent of the world’s marketed ADCs and 50 percent of ADCs approved by the US Food and Drug Administration (FDA).Samsung Biologics said it will support a series of LigaChem Biosciences’ ADC programs at its new dedicated ADC facility. Similarly, Cerbios-Pharma announced significant enhancements to its ADC production capabilities. Cerbios also announced the expansion of its high potency active pharmaceutical ingredients (HPAPIs) production capabilities. On March 31, Cerbios-Pharma got acquired by Healthcare Advanced Synthesis, a leading developer of APIs, HPAPIs and anticancer compounds. Both these global players are based in Switzerland. Overall, HPAPIs saw significant investments. Quotient Sciences made headlines with the successful completion of a US$ 1.4 million project designed to improve high potency handling capabilities at its Philadelphia (US) facility. The initiative focused on upgrading infrastructure and implementing advanced safety protocols to manage HPAPIs more effectively.Polfa Tarchomin achieved significant milestones in enhancing its pharmaceutical manufacturing capabilities. The company successfully completed the site acceptance test (SAT) for its vial filling and packaging line at the Center for Development and Production of Highly Potent Drugs, ensuring full functionality and compliance with good manufacturing practice (GMP) standards.Additionally, Polfa Tarchomin is installing a high-tech, high-containment robotic ONCO LINE designed for aseptic production of highly potent pharmaceutical products, including lyophilisates and liquid formulations in vials and pre-filled syringes. Developed in collaboration with leading global suppliers, this line supports multiple packaging formats and comes with advanced systems. With an annual production capacity of up to 6 million units, this line will set a new benchmark in pharmaceutical manufacturing.In a significant development for analytical testing, SK Pharmteco launched an enhanced laboratory specifically designed for HPAPIs. The new facility is in California (US).  View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Evonik expands RNA portfolio; Catalent to support Galapagos’ CAR-T therapy trialsThe success of mRNA vaccines and the growing interest in RNA therapeutics is luring CDMOs to rapidly expand their capabilities in this emerging area. Evonik, in collaboration with ST Pharm, announced plans to expand its portfolio of RNA and nucleic acid therapeutic services during Q1. The partnership enables Evonik to provide customized nucleic acids from ST Pharm alongside its portfolio of lipid and lipid nanoparticle (LNP) drug product development services.ReciBioPharm secured a grant from the Bill & Melinda Gates Foundation to advance RNA manufacturing technologies that meet FDA standards with a focus on improving access to RNA therapeutics in low- and middle-income countries.The cell and gene therapy sector also witnessed remarkable activity in Q1 2025. Catalent announced it will support Galapagos’ decentralized CAR T therapy trials for GLPG5101 for relapsed/refractory non-Hodgkin lymphoma indications.Similarly, AGC Biologics announced it will manufacture and supply lentiviral vectors for Adaptimmune’s solid tumor cell therapy initiatives. And, Genenta and AGC Biologics strengthened their cell therapy manufacturing pact through a collaboration agreement. This grants Genenta access to the exclusive GMP suite at the AGC Biologics Cell and Gene Center of Excellence in Milan, dedicated to manufacturing cell therapy products.  View CDMO Activity Tracker for Q1 2025 (Free Excel Available) EUROAPI, StrainChem join hands to develop peptides; Fermion expands flow chemistry capabilitiesEven traditional therapeutics like peptides and small molecules saw considerable investments by CDMOs. For instance, EUROAPI and StrainChem announced a collaborative venture to develop liquid phase peptides. The partnership aims to harness advanced synthesis techniques and innovative technologies for more efficient peptide manufacturing. Through this collaboration, EUROAPI and StrainChem will offer their customers a one-stop shop solution for peptides. In one of the most ambitious expansions announced this quarter, CordenPharma unveiled plans to invest over € 1 billion (US$ 1.10 billion) over the next three years in building and expanding small, medium, and large peptide manufacturing facilities across Europe and the US. That includes a new greenfield facility for peptide manufacturing in the Basel region of Switzerland, valued at over € 500 million (US$ 553 million).In obesity treatments, Viking Therapeutics agreed to pay US$ 150 million to CordenPharma for the production of its dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) agonist VK2735.In a show of confidence, Indian CDMO Neuland Labs’ board approved a ₹ 3.42 billion (approximately US$ 42 million) capital expenditure plan. The approved capex is earmarked for enhancing the company’s peptide synthesizer reactor capacity and building additional capacity to meet growing demand.In the small molecule space, Fermion announced a strategic investment to expand its flow chemistry capabilities, aiming to enhance processes and sustainability by integrating continuous flow techniques into manufacturing. This technology offers advantages in scalability, process control, and safety, positioning Fermion at the forefront of pharmaceutical innovation.Recipharm announced a major expansion of its aseptic filling capabilities, encompassing process development, pilot-scale production, and clinical supply operations. Similarly, Curia announced significant expansions to its global network of sterile fill-finish sites, aiming to enhance production capacity, streamline supply chains, and improve overall quality in sterile pharmaceutical manufacturing.  View CDMO Activity Tracker for Q1 2025 (Free Excel Available) Our viewDuring Q1 2025, the CDMO sector continued to evolve towards higher-value and more complex services. This only underscores the crucial role CDMOs are playing in supporting growth and innovation in the pharmaceutical industry.With the Trump administration in the US triggering a global tariff war, drugmakers have no option but to reshape their supply chains. And this means more business for CDMOs that manufacture drugs in the US. In the coming quarter, we expect strong dealmaking and increased focus on innovation in the CDMO sector. 
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    Impressions: 1486

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-axplora-enhances-adc-capacities-quotient-beefs-up-hpapi-capabilities-evonik-euroapi-forge-deals

    #PharmaFlow by PHARMACOMPASS
    10 Apr 2025
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    NEWS #PharmaBuzz

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    Indian pharma stocks 'breathe easy' on US tariffs exemption
    Indian pharma stocks 'breathe easy' on US tariffs exemption

    03 Apr 2025

    // REUTERS

    https://www.reuters.com/world/india/indian-pharma-stocks-defy-market-slump-us-tariffs-exemption-2025-04-03/

    REUTERS
    03 Apr 2025
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    Cipla and Formosa sign licensing deal for Clobetasol Suspension
    Cipla and Formosa sign licensing deal for Clobetasol Suspension

    18 Mar 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/cipla-and-formosa-sign-multi-regional-licensing-deal-for-clobetasol-suspension-302403405.html

    PR NEWSWIRE
    18 Mar 2025
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    Cipla CEO: Tariffs Should Not Dictate Indian Pharma Business
    Cipla CEO: Tariffs Should Not Dictate Indian Pharma Business

    03 Mar 2025

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/tariffs-should-not-dictate-how-indian-drugmakers-do-business-cipla-ceo-says/articleshow/118633708.cms

    ECONOMICTIMES
    03 Mar 2025
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    Cipla Beats Q3 Profit View as India Offsets Weak U.S. Sales
    Cipla Beats Q3 Profit View as India Offsets Weak U.S. Sales

    28 Jan 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/indias-cipla-beats-q3-profit-view-strong-demand-north-america-2025-01-28/

    REUTERS
    28 Jan 2025
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    Cipla Goa facility receives form 483 with 1 observation
    Cipla Goa facility receives form 483 with 1 observation

    21 Jan 2025

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/markets/stocks/news/cipla-shares-in-focus-after-goa-facility-receives-form-483-with-one-observation-from-usfda/articleshow/117413516.cms?from=mdr

    ECONOMICTIMES
    21 Jan 2025
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    Briefs: Cipla and IOL Chemicals and Pharmaceuticals
    Briefs: Cipla and IOL Chemicals and Pharmaceuticals

    21 Jan 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/briefs-cipla-and-iol-chemicals-and-pharmaceuticals-16690

    INDPHARMAPOST
    21 Jan 2025
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    ALL APIs

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    01

    Amlodipine Besylate

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

    WRIB
    Not Confirmed
    arrow

    Amlodipine Besylate

    India

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

    arrow
    WRIB
    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 : 2017-03-17

    Pay. Date : 2017-03-06

    DMF Number : 17032

    Submission : 2003-12-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2015-140 - Rev 00

    Issue Date : 2020-09-16

    Type : Chemical

    Substance Number : 1491

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10131

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, INDIA

    Initial Date of Registration : 2009-06-30

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-20

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0113

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7561

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (35kg/35kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Boehringer Ingelheim Korea Ltd.

    Registration Date : 2021-11-05

    Registration Number : 20101029-130-H-18-03(4)

    Manufacturer Name : Cipla Limited

    Manufacturer Address : Virgonagar Post, Old Madras Road, Bangalore-560 049, India

     VMF Others AUDIT
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    02

    Celecoxib

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

    WRIB
    Not Confirmed
    arrow

    Celecoxib

    India

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

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    WRIB
    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 : 2013-09-28

    Pay. Date : 2013-09-20

    DMF Number : 16671

    Submission : 2003-06-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-186 - Rev 01

    Issue Date : 2023-05-30

    Type : Chemical

    Substance Number : 2591

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10110

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, INDIA

    Initial Date of Registration : 2018-08-20

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0144nA2

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7533

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Ildong Pharmaceutical Co., Ltd.

    Registration Date : 2020-09-08

    Registration Number : 20190104-209-J-128(4)

    Manufacturer Name : Cipla Limited

    Manufacturer Address : D-7, MIDC, Industrial Area, Kurkumbh, Taluka Daund, Pune 413 802, Maharashtra State, India

     VMF Others AUDIT
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    03

    Etoposide

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

    WRIB
    Not Confirmed
    arrow

    Etoposide

    India

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

    arrow
    WRIB
    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10642

    Submission : 1993-12-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2007-061 - Rev 06

    Issue Date : 2024-09-17

    Type : Chemical

    Substance Number : 823

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10214

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, INDIA

    Initial Date of Registration : 2010-08-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-20

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0113

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7514

    Start Marketing Date : 2018-07-13

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (4kg/4kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    04

    Risedronate Sodium

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

    WRIB
    Not Confirmed
    arrow

    Risedronate Sodium

    India

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

    arrow
    WRIB
    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 : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20162

    Submission : 2007-03-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-130 - Rev 00

    Issue Date : 2020-04-28

    Type : Chemical

    Substance Number : 2572

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10141

    Registrant's Address : Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai - 400 013, INDIA

    Initial Date of Registration : 2011-09-07

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0144nA2

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7653

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Market
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    05

    Alendronate Sodium

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

    WRIB
    Not Confirmed
    arrow

    Alendronate Sodium

    India

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

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    WRIB
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-12-15

    Pay. Date : 2019-12-11

    DMF Number : 14334

    Submission : 1999-08-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2005-126 - Rev 04

    Issue Date : 2018-08-29

    Type : Chemical

    Substance Number : 1564

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0144nA2

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7525

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Cetirizine Dihydrochloride

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

    WRIB
    Not Confirmed
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    Cetirizine Dihydrochloride

    India

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

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    WRIB
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-03-25

    Pay. Date : 2016-03-08

    DMF Number : 15145

    Submission : 2000-11-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-081 - Rev 07

    Issue Date : 2019-08-09

    Type : Chemical

    Substance Number : 1084

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-05

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0143n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7528

    Start Marketing Date : 2018-12-07

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (20kg/20kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hanol Biopharma Co., Ltd.

    Registration Date : 2011-11-18

    Registration Number : 20080829-40-C-239-12(6)

    Manufacturer Name : Cipla Limited

    Manufacturer Address : A-33& A-37/2/2, MIDC, Patalganga-410 220, District:Raigad, Maharashtra State

     VMF Others AUDIT
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    07

    Felodipine

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

    WRIB
    Not Confirmed
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    Felodipine

    India

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

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    WRIB
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11449

    Submission : 1995-04-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-022 - Rev 05

    Issue Date : 2023-04-06

    Type : Chemical

    Substance Number : 1013

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-20

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0113

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7519

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (40kg/40kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : KMS Pharmaceutical Co., Ltd.

    Registration Date : 2011-06-30

    Registration Number : 20050831-69-B-181-03(2)

    Manufacturer Name : Cipla Limited

    Manufacturer Address : Virgonagar, Old Madras Road, Bangalore 560 049, India (Mumbai Central Mumbai 400 008 India)

     VMF Others AUDIT
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    08

    Fluticasone Propionate

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

    WRIB
    Not Confirmed
    arrow

    Fluticasone Propionate

    India

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

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    WRIB
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-25

    Pay. Date : 2014-08-14

    DMF Number : 15774

    Submission : 2001-12-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2020-075 - Rev 02

    Issue Date : 2024-10-25

    Type : Chemical

    Substance Number : 1750

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0144nA2

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7531

    Start Marketing Date : 1999-06-17

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    09

    Omeprazole

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

    WRIB
    Not Confirmed
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    Omeprazole

    India

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

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    WRIB
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12827

    Submission : 1998-01-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1997-122 - Rev 05

    Issue Date : 2015-03-19

    Type : Chemical

    Substance Number : 942

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-20

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0113

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7520

    Start Marketing Date : 2016-01-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (30kg/30kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Ondansetron Hydrochloride

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

    WRIB
    Not Confirmed
    arrow

    Ondansetron Hydrochloride

    India

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

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    WRIB
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15724

    Submission : 2001-11-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2006-279 - Rev 04

    Issue Date : 2025-02-03

    Type : Chemical

    Substance Number : 2016

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0144nA2

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 53104-7540

    Start Marketing Date : 2018-11-15

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    FDF Dossiers

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    01

    Brand Name : Abacavir & Lamivudin...

    South Africa
    Spring Meeting
    Not Confirmed
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    Brand Name : Abacavir & Lamivudin...

    South Africa
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    Spring Meeting
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : TAB

    Brand Name : Abacavir & Lamivudine Cip...

    Dosage Strength : 600mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    02

    Brand Name : Damicava

    South Africa
    Spring Meeting
    Not Confirmed
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    Brand Name : Damicava

    South Africa
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    Spring Meeting
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : TAB

    Brand Name : Damicava

    Dosage Strength : 600mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Market
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    03

    Brand Name : Cipla-Abacavir 300

    South Africa
    Spring Meeting
    Not Confirmed
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    Brand Name : Cipla-Abacavir 300

    South Africa
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    Spring Meeting
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : TAB

    Brand Name : Cipla-Abacavir 300

    Dosage Strength : 300mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    04

    Brand Name : Divudine 120/60

    South Africa
    Spring Meeting
    Not Confirmed
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    Brand Name : Divudine 120/60

    South Africa
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    Spring Meeting
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : TAB

    Brand Name : Divudine 120/60

    Dosage Strength : 120mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Market
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    05

    Brand Name : Damicava Paed

    South Africa
    Spring Meeting
    Not Confirmed
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    Brand Name : Damicava Paed

    South Africa
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    Spring Meeting
    Not Confirmed
    • fda
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    Regulatory Info : Originator

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : DSP

    Brand Name : Damicava Paed

    Dosage Strength : 60mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    06

    Brand Name : Quadrimune

    South Africa
    Spring Meeting
    Not Confirmed
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    Brand Name : Quadrimune

    South Africa
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    Spring Meeting
    Not Confirmed
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    Regulatory Info : Originator

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : CAP

    Brand Name : Quadrimune

    Dosage Strength : 30mg

    Packaging : 120X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Market
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    07

    Brand Name : Cipla Abacavir Oral ...

    South Africa
    Spring Meeting
    Not Confirmed
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    Brand Name : Cipla Abacavir Oral ...

    South Africa
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    Spring Meeting
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : SOL

    Brand Name : Cipla Abacavir Oral Solut...

    Dosage Strength : 20mg/ml

    Packaging : 240X1mg/ml

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Market
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    08

    Brand Name : Divudine 120/60

    South Africa
    Spring Meeting
    Not Confirmed
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    Brand Name : Divudine 120/60

    South Africa
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    Spring Meeting
    Not Confirmed
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    Regulatory Info : Generic

    Registration Country : South Africa

    Abacavir

    Cipla Medpro South Africa

    Dosage Form : TAB

    Brand Name : Divudine 120/60

    Dosage Strength : 120mg

    Packaging : 60X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Market
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    09

    Brand Name : ABACAVIR SULFATE

    India
    Spring Meeting
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    India
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    Spring Meeting
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    ABACAVIR SULFATE

    Cipla

    Dosage Form : TABLET;ORAL

    Brand Name : ABACAVIR SULFATE

    Dosage Strength : EQ 300MG BASE

    Packaging :

    Approval Date : 2017-11-21

    Application Number : 78119

    Regulatory Info : RX

    Registration Country : USA

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    10

    Brand Name : ABACAVIR SULFATE

    India
    Spring Meeting
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    India
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    Spring Meeting
    Not Confirmed
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    Regulatory Info :

    Registration Country : USA

    ABACAVIR SULFATE

    Cipla

    Dosage Form : SOLUTION; ORAL

    Brand Name : ABACAVIR SULFATE

    Dosage Strength : 20MG

    Packaging :

    Approval Date :

    Application Number : 78348

    Regulatory Info :

    Registration Country : USA

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    Contact Cipla and get a quotation

    Cipla is a supplier offers 326 products (APIs, Excipients or Intermediates).

    Find a price of Amlodipine Besylate bulk with DMF, CEP, JDMF, WC offered by Cipla

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