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    Company profile for Hikma Pharmaceuticals

    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products....
    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.

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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

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    12 Mar 2025
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    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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    Hikma gets Health Canada approval for Kloxxado Nasal Spray 8 mg
    Hikma gets Health Canada approval for Kloxxado Nasal Spray 8 mg

    20 Mar 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/03/20/3046184/33240/en/Hikma-announces-Health-Canada-approval-of-KLOXXADO-naloxone-HCl-Nasal-Spray-8-mg.html

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    20 Mar 2025
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    Enforcement Report - Week of March 12, 2025
    Enforcement Report - Week of March 12, 2025

    12 Mar 2025

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-12-2025-99448.pdf

    FDA
    12 Mar 2025
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    Axsome Therapeutics Settles Sunosi Patent Litigation with Hikma
    Axsome Therapeutics Settles Sunosi Patent Litigation with Hikma

    05 Mar 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/03/05/3037271/33090/en/Axsome-Therapeutics-Settles-Sunosi-solriamfetol-Patent-Litigation-with-Hikma-Pharmaceuticals-USA.html

    GLOBENEWSWIRE
    05 Mar 2025
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    Hikma & M42 sign strategic MoU to advance health innovation in UAE
    Hikma & M42 sign strategic MoU to advance health innovation in UAE

    06 Feb 2025

    // BIOSPECTRUM

    https://www.biospectrumasia.com/news/25/25537/hikma-and-m42-sign-strategic-mou-to-advance-healthcare-innovation-in-uae.html

    BIOSPECTRUM
    06 Feb 2025
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    Hikma Pharma`s Generics Ertugliflozin Receives Approval in US
    Hikma Pharma`s Generics Ertugliflozin Receives Approval in US

    21 Jan 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216842

    FDA
    21 Jan 2025
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    Enforcement Report - Week of January 15, 2025
    Enforcement Report - Week of January 15, 2025

    15 Jan 2025

    // FDA

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-15-2025-7287.pdf

    FDA
    15 Jan 2025
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    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we establish...
    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.
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    Hikma Pharmaceuticals

    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.

    About the Company : Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will contin...

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    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we establish...
    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.
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    Hikma Pharmaceuticals

    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.

    About the Company : Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will contin...

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    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we establish...
    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.
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    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.

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    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we establish...
    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.
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    04

    Dasatinib Monohydrate

    United Kingdom
    ASPEN
    Not Confirmed
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    Dasatinib Monohydrate

    United Kingdom
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    ASPEN
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    Hikma Pharmaceuticals

    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.

    About the Company : Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will contin...

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    Enalaprilat

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    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we establish...
    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.
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    05

    Enalaprilat

    United Kingdom
    ASPEN
    Not Confirmed
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    Enalaprilat

    United Kingdom
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    Hikma Pharmaceuticals

    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.

    About the Company : Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will contin...

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    Erlotinib Hydrochloride

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    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we establish...
    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.
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    06

    Erlotinib Hydrochloride

    United Kingdom
    ASPEN
    Not Confirmed
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    Erlotinib Hydrochloride

    United Kingdom
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    Hikma Pharmaceuticals

    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.

    About the Company : Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will contin...

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    Fluticasone

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    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we establish...
    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.
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    07

    Fluticasone

    United Kingdom
    ASPEN
    Not Confirmed
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    Fluticasone

    United Kingdom
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    Hikma Pharmaceuticals

    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.

    About the Company : Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will contin...

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    Glycopyrrolate

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    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we establish...
    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.
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    08

    Glycopyrrolate

    United Kingdom
    ASPEN
    Not Confirmed
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    Glycopyrrolate

    United Kingdom
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    Hikma Pharmaceuticals

    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.

    About the Company : Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will contin...

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    Ibrutinib

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    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we establish...
    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.
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    09

    Ibrutinib

    United Kingdom
    ASPEN
    Not Confirmed
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    Ibrutinib

    United Kingdom
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    Hikma Pharmaceuticals

    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.

    About the Company : Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will contin...

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    Methylprednisolone Acetate

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    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we establish...
    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.
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    10

    Methylprednisolone Acetate

    United Kingdom
    ASPEN
    Not Confirmed
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    Methylprednisolone Acetate

    United Kingdom
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    ASPEN
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    Hikma Pharmaceuticals

    Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will continue to innovate and find practical solutions to transform the lives of the millions of people we serve. We were founded in Jordan in 1978, where we established ourselves as a leading supplier of branded generics and in-licensed products. We built our presence in the MENA and established the first FDA-inspected manufacturing plant in the region. It was also in this decade that we extended our reach beyond the Middle East and acquired land in Portugal.

    About the Company : Founded more than 40 years ago, our purpose has always been to provide high-quality, affordable medicines to the people who need them. Based on the solid foundation we have built, we will contin...

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    Drugs in Development

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    Hikma announces Health Canada approval of KLOXXADO® (naloxone HCl) Nasal Spray 8 mg

    Details:

    Kloxxado delivers 8 mg of naloxone hydrochloride, an opioid antagonist, approved as a ready to use nasal spray to reverse the effects of opioid overdose.


    Lead Product(s): Naloxone Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Kloxxado

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 20, 2025

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    01

    Hikma Pharmaceuticals

    United Kingdom
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    Hikma Pharmaceuticals

    United Kingdom
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    Lead Product(s) : Naloxone Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Hikma announces Health Canada approval of KLOXXADO® (naloxone HCl) Nasal Spray 8 mg

    Details : Kloxxado delivers 8 mg of naloxone hydrochloride, an opioid antagonist, approved as a ready to use nasal spray to reverse the effects of opioid overdose.

    Product Name : Kloxxado

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    March 20, 2025

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    Emergent BioSolutions Gains Exclusive Rights to KLOXXADO® Nasal Spray

    Details:

    Under the terms of the agreement, Emergent will be responsible for the distribution of Kloxxado (Naloxone HCl). It is being indicated for the treatment of known or suspected opioid overdose.


    Lead Product(s): Naloxone Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Kloxxado

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Emergent BioSolutions

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement January 14, 2025

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    02

    Hikma Pharmaceuticals

    United Kingdom
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    Hikma Pharmaceuticals

    United Kingdom
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    Lead Product(s) : Naloxone Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Emergent BioSolutions

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Emergent BioSolutions Gains Exclusive Rights to KLOXXADO® Nasal Spray

    Details : Under the terms of the agreement, Emergent will be responsible for the distribution of Kloxxado (Naloxone HCl). It is being indicated for the treatment of known or suspected opioid overdose.

    Product Name : Kloxxado

    Product Type : Controlled Substance

    Upfront Cash : Undisclosed

    January 14, 2025

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    US FDA Approves Hikma's Generic Version of Novo's Diabetes Drug Victoza

    Details:

    Victoza-Generic (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is indicated for the treatment of patients with type 2 diabetes mellitus.


    Lead Product(s): Liraglutide

    Therapeutic Area: Endocrinology Brand Name: Victoza-Generic

    Study Phase: ApprovedProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 26, 2024

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    03

    Hikma Pharmaceuticals

    United Kingdom
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    Hikma Pharmaceuticals

    United Kingdom
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    Lead Product(s) : Liraglutide

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    US FDA Approves Hikma's Generic Version of Novo's Diabetes Drug Victoza

    Details : Victoza-Generic (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is indicated for the treatment of patients with type 2 diabetes mellitus.

    Product Name : Victoza-Generic

    Product Type : Peptide

    Upfront Cash : Not Applicable

    December 26, 2024

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    Hikma launches Furosemide Injection, USP, in the US

    Details:

    Furosemide injection is indicated in adults & pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.


    Lead Product(s): Furosemide

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Furosemide Injection-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 09, 2024

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    04

    Hikma Pharmaceuticals

    United Kingdom
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    ASPEN
    Not Confirmed

    Hikma Pharmaceuticals

    United Kingdom
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    Lead Product(s) : Furosemide

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Hikma launches Furosemide Injection, USP, in the US

    Details : Furosemide injection is indicated in adults & pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.

    Product Name : Furosemide Injection-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    December 09, 2024

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    Collegium Announces Authorized Generic Agreement with Hikma for Nucynta® and Nucynta® ER

    Details:

    Through the agreement, Collegium will exclusively manufacture and supply Hikma with all authorized generic products for sale, including Nucynta-Generic (tapentadol HCl).


    Lead Product(s): Tapentadol

    Therapeutic Area: Neurology Brand Name: Nucynta-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Collegium Pharmaceutical

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement April 29, 2024

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    05

    Hikma Pharmaceuticals

    United Kingdom
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    Not Confirmed

    Hikma Pharmaceuticals

    United Kingdom
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    Lead Product(s) : Tapentadol

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Recipient : Collegium Pharmaceutical

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Collegium Announces Authorized Generic Agreement with Hikma for Nucynta® and Nucynta® ER

    Details : Through the agreement, Collegium will exclusively manufacture and supply Hikma with all authorized generic products for sale, including Nucynta-Generic (tapentadol HCl).

    Product Name : Nucynta-Generic

    Product Type : Small molecule

    Upfront Cash : Undisclosed

    April 29, 2024

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    Hyloris Announces Launch of Maxigesic® IV in the U.S. and Approval in Canada

    Details:

    Combogesic IV (acetaminophen & ibuprofen) is an opioid-free pain relief medicine approved for adults to relieve mild to moderate pain and manage moderate to severe pain as an adjunct to opioids.


    Lead Product(s): Paracetamol,Ibuprofen

    Therapeutic Area: Neurology Brand Name: Combogesic

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Hyloris Pharmaceuticals

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 27, 2024

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    06

    Hikma Pharmaceuticals

    United Kingdom
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    ASPEN
    Not Confirmed

    Hikma Pharmaceuticals

    United Kingdom
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    ASPEN
    Not Confirmed
    • fda
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    Lead Product(s) : Paracetamol,Ibuprofen

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Recipient : Hyloris Pharmaceuticals

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Hyloris Announces Launch of Maxigesic® IV in the U.S. and Approval in Canada

    Details : Combogesic IV (acetaminophen & ibuprofen) is an opioid-free pain relief medicine approved for adults to relieve mild to moderate pain and manage moderate to severe pain as an adjunct to opioids.

    Product Name : Combogesic

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    February 27, 2024

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    Hikma Announces US Launch of COMBOGESIC® IV

    Details:

    Combogesic IV (acetaminophen & ibuprofen) is an opioid-free pain relief medicine approved for adults to relieve mild to moderate pain and manage moderate to severe pain as an adjunct to opioids.


    Lead Product(s): Paracetamol,Ibuprofen

    Therapeutic Area: Neurology Brand Name: Combogesic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 05, 2024

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    07

    Hikma Pharmaceuticals

    United Kingdom
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    Lead Product(s) : Paracetamol,Ibuprofen

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Hikma Announces US Launch of COMBOGESIC® IV

    Details : Combogesic IV (acetaminophen & ibuprofen) is an opioid-free pain relief medicine approved for adults to relieve mild to moderate pain and manage moderate to severe pain as an adjunct to opioids.

    Product Name : Combogesic

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    February 05, 2024

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    CanariaBio and Hikma Announce the Signing of Distribution and License Agreement for Oregovomab in MENA Region

    Details:

    Under the agreement, Hikma gains right for MAb-B43.13 (oregovomab), a murine monoclonal antibody, being tested in combination with carboplatin and paclitaxel for patients with advanced ovarian cancer, in the Middle East and North Africa (MENA) region.


    Lead Product(s): Oregovomab,Paclitaxel,Carboplatin

    Therapeutic Area: Oncology Brand Name: MAb-B43.13

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: CanariaBio

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement October 10, 2023

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    Lead Product(s) : Oregovomab,Paclitaxel,Carboplatin

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : CanariaBio

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    CanariaBio and Hikma Announce the Signing of Distribution and License Agreement for Oregovomab in ...

    Details : Under the agreement, Hikma gains right for MAb-B43.13 (oregovomab), a murine monoclonal antibody, being tested in combination with carboplatin and paclitaxel for patients with advanced ovarian cancer, in the Middle East and North Africa (MENA) region.

    Product Name : MAb-B43.13

    Product Type : Large molecule

    Upfront Cash : Undisclosed

    October 10, 2023

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    Cosmo and Hikma Sign License for Winlevi® in 17 Middle East and North Africa Countries

    Details:

    Under the terms of the agreement, Hikma will receive from Cosmo, the exclusive right to register and commercialize Winlevi (clascoterone) in African countries, which is indicated for acne vulgaris.


    Lead Product(s): Clascoterone

    Therapeutic Area: Dermatology Brand Name: Winlevi

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Cosmo Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: $0.7 million

    Deal Type: Licensing Agreement October 02, 2023

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    09

    Hikma Pharmaceuticals

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    Lead Product(s) : Clascoterone

    Therapeutic Area : Dermatology

    Highest Development Status : Approved

    Recipient : Cosmo Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Cosmo and Hikma Sign License for Winlevi® in 17 Middle East and North Africa Countries

    Details : Under the terms of the agreement, Hikma will receive from Cosmo, the exclusive right to register and commercialize Winlevi (clascoterone) in African countries, which is indicated for acne vulgaris.

    Product Name : Winlevi

    Product Type : Small molecule

    Upfront Cash : $0.7 million

    October 02, 2023

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    Korea's SK Biopharma Enters MENA Through Strategic Partnership with Hikma

    Details:

    Under the terms of the agreement, Hikma will have priority rights for the commercialisation and manufacture of SK Biopharmaceuticals’ current and future pipeline of innovative products for 17 countries in the MENA region.


    Lead Product(s): Cenobamate

    Therapeutic Area: Neurology Brand Name: Xcopri

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: SK Biopharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement August 21, 2023

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    10

    Hikma Pharmaceuticals

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    Lead Product(s) : Cenobamate

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Recipient : SK Biopharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Korea's SK Biopharma Enters MENA Through Strategic Partnership with Hikma

    Details : Under the terms of the agreement, Hikma will have priority rights for the commercialisation and manufacture of SK Biopharmaceuticals’ current and future pipeline of innovative products for 17 countries in the MENA region.

    Product Name : Xcopri

    Product Type : Small molecule

    Upfront Cash : Undisclosed

    August 21, 2023

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    01

    Brand Name : ABIRATERONE ACETATE

    United Kingdom
    ASPEN
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    Brand Name : ABIRATERONE ACETATE

    United Kingdom
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    Regulatory Info : RX

    Registration Country : USA

    ABIRATERONE ACETATE

    Hikma Pharmaceuticals

    Dosage Form : TABLET;ORAL

    Brand Name : ABIRATERONE ACETATE

    Dosage Strength : 250MG

    Packaging :

    Approval Date : 2018-10-31

    Application Number : 208339

    Regulatory Info : RX

    Registration Country : USA

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    02

    Brand Name : ACARBOSE

    United Kingdom
    ASPEN
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    Brand Name : ACARBOSE

    United Kingdom
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    ASPEN
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    Regulatory Info : RX

    Registration Country : USA

    ACARBOSE

    Hikma Pharmaceuticals

    Dosage Form : TABLET;ORAL

    Brand Name : ACARBOSE

    Dosage Strength : 50MG

    Packaging :

    Approval Date : 2008-05-07

    Application Number : 78470

    Regulatory Info : RX

    Registration Country : USA

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    03

    Brand Name : ACARBOSE

    United Kingdom
    ASPEN
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    Brand Name : ACARBOSE

    United Kingdom
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    Regulatory Info : RX

    Registration Country : USA

    ACARBOSE

    Hikma Pharmaceuticals

    Dosage Form : TABLET;ORAL

    Brand Name : ACARBOSE

    Dosage Strength : 25MG

    Packaging :

    Approval Date : 2008-05-07

    Application Number : 78470

    Regulatory Info : RX

    Registration Country : USA

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    04

    Brand Name : ACARBOSE

    United Kingdom
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    Brand Name : ACARBOSE

    United Kingdom
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    Regulatory Info : RX

    Registration Country : USA

    ACARBOSE

    Hikma Pharmaceuticals

    Dosage Form : TABLET;ORAL

    Brand Name : ACARBOSE

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2008-05-07

    Application Number : 78470

    Regulatory Info : RX

    Registration Country : USA

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    05

    Brand Name : ACETAMINOPHEN

    United Kingdom
    ASPEN
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    Brand Name : ACETAMINOPHEN

    United Kingdom
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    ASPEN
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    Regulatory Info : RX

    Registration Country : USA

    ACETAMINOPHEN

    Hikma Pharmaceuticals

    Dosage Form : SOLUTION;INTRAVENOUS

    Brand Name : ACETAMINOPHEN

    Dosage Strength : 1GM/100ML (10MG/ML)

    Packaging :

    Approval Date : 2016-06-13

    Application Number : 202605

    Regulatory Info : RX

    Registration Country : USA

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    06

    Brand Name : ACETAMINOPHEN

    United Kingdom
    ASPEN
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    Brand Name : ACETAMINOPHEN

    United Kingdom
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    Regulatory Info : RX

    Registration Country : USA

    ACETAMINOPHEN

    Hikma Pharmaceuticals

    Dosage Form : SOLUTION;INTRAVENOUS

    Brand Name : ACETAMINOPHEN

    Dosage Strength : 1GM/100ML (10MG/ML)

    Packaging :

    Approval Date : 2022-06-03

    Application Number : 206968

    Regulatory Info : RX

    Registration Country : USA

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    07

    Brand Name : BUTALBITAL, ACETAMIN...

    United Kingdom
    ASPEN
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    Brand Name : BUTALBITAL, ACETAMIN...

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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Hikma Pharmaceuticals

    Dosage Form : CAPSULE;ORAL

    Brand Name : BUTALBITAL, ACETAMINOPHEN...

    Dosage Strength : 325MG;50MG;40MG

    Packaging :

    Approval Date : 2022-03-25

    Application Number : 215135

    Regulatory Info : DISCN

    Registration Country : USA

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    Brand Name : BUTALBITAL, ACETAMIN...

    United Kingdom
    ASPEN
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    Brand Name : BUTALBITAL, ACETAMIN...

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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Hikma Pharmaceuticals

    Dosage Form : CAPSULE;ORAL

    Brand Name : BUTALBITAL, ACETAMINOPHEN...

    Dosage Strength : 500MG;50MG;40MG

    Packaging :

    Approval Date : 1998-10-28

    Application Number : 40261

    Regulatory Info : DISCN

    Registration Country : USA

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    09

    Brand Name : BUTALBITAL, ACETAMIN...

    United Kingdom
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    Brand Name : BUTALBITAL, ACETAMIN...

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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Hikma Pharmaceuticals

    Dosage Form : CAPSULE;ORAL

    Brand Name : BUTALBITAL, ACETAMINOPHEN...

    Dosage Strength : 300MG;50MG;40MG

    Packaging :

    Approval Date : 2022-03-25

    Application Number : 215135

    Regulatory Info : DISCN

    Registration Country : USA

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    10

    Brand Name : BUTALBITAL, ACETAMIN...

    United Kingdom
    ASPEN
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    Brand Name : BUTALBITAL, ACETAMIN...

    United Kingdom
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    Regulatory Info : DISCN

    Registration Country : USA

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Hikma Pharmaceuticals

    Dosage Form : TABLET;ORAL

    Brand Name : BUTALBITAL, ACETAMINOPHEN...

    Dosage Strength : 500MG;50MG;40MG

    Packaging :

    Approval Date : 1999-08-18

    Application Number : 40336

    Regulatory Info : DISCN

    Registration Country : USA

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    FDA Orange Book

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
    ASPEN
    Not Confirmed
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    FDA Audited

    USA
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    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-09-19

    West-ward Pharmaceutical Corp

    City : Columbus

    State : OH

    Country/Area : US

    Zip : 43228-9579

    District : CIN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-09-19

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    02

    FDA Audited

    USA
    ASPEN
    Not Confirmed
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    FDA Audited

    USA
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    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-08-29

    West-ward Pharmaceutical Corp

    City : Columbus

    State : OH

    Country/Area : US

    Zip : 43228-9579

    District : CIN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-08-29

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    03

    FDA Audited

    USA
    ASPEN
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    FDA Audited

    USA
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    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-05-18

    West-ward Pharmaceutical Corp

    City : Columbus

    State : OH

    Country/Area : US

    Zip : 43228-9579

    District : CIN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-05-18

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    04

    FDA Audited

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    FDA Audited

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    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-04-04

    West-ward Pharmaceutical Corp

    City : Cherry Hill

    State : NJ

    Country/Area : US

    Zip : 08003-4002

    District : NWJ

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-04-04

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    05

    FDA Audited

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    FDA Audited

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    ASPEN
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-06-19

    Hikma Pharmaceuticals

    City : Terrugem Snt

    State :

    Country/Area : PT

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-06-19

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    06

    FDA Audited

    USA
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    FDA Audited

    USA
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    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-05-21

    West-ward Pharmaceutical Corp

    City : Cherry Hill

    State : NJ

    Country/Area : US

    Zip : 08003-4002

    District : NWJ

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-05-21

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    07

    FDA Audited

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    FDA Audited

    USA
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    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-09-19

    West-ward Pharmaceutical Corp

    City : Cherry Hill

    State : NJ

    Country/Area : US

    Zip : 08003-4002

    District : NWJ

    Center : CDER

    Project Area : Unapproved and Misbranded Drugs

    District Decision : No Action Indicated

    Inspection End Date : 2014-09-19

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    08

    FDA Audited

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    FDA Audited

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    ASPEN
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-08-13

    West-ward Pharmaceutical Corp

    City : Memphis

    State : TN

    Country/Area : US

    Zip : 38118-7809

    District : NOL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-08-13

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    09

    FDA Audited

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    FDA Audited

    USA
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    ASPEN
    Not Confirmed

    District Decision : Official Action Indicated

    Inspection End Date : 2014-06-06

    BEDFORD LABS

    City : Bedford

    State : OH

    Country/Area : US

    Zip : 44146-4650

    District : CIN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Official Action Indicated

    Inspection End Date : 2014-06-06

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    10

    FDA Audited

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    ASPEN
    Not Confirmed
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    FDA Audited

    USA
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    ASPEN
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-05-22

    Thymoorgan Pharmazie GmbH

    City : Vienenburg

    State :

    Country/Area : DE

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-05-22

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