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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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    About

    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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    1 New Burlington Place, Mayfair, London, W1S 2HR
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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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    12 Mar 2025
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    AI drug discovery market to grow 30% CAGR, to reach US$ 35 bn by 2034; Novo, Lilly, BMS forge deals

    AI drug discovery market to grow 30% CAGR, to reach US$ 35 bn by 2034; Novo, Lilly, BMS forge deals

    Artificial intelligence (AI) is emerging as a transformative force in drug discovery and development. The global AI in drug discovery market was valued at US$ 1.99 billion in 2024 and is estimated to reach US$ 2.65 billion in 2025. Going forward, the market is expected to grow at an impressive compounded annual growth rate (CAGR) of 29.6 percent, to reach a market size of US$ 35.42 billion by 2034, says a report by Polaris Market Research. This growth expectation mirrors the eagerness within the biopharma industry to leverage AI in order to overcome the traditional barriers of lengthy timelines, exorbitant costs, and high failure rates. This eagerness is also being manifested in deal making — Big Pharma has been busy forging alliances with AI-driven drug discovery companies. Over the last two years, almost every big drugmaker, including Novo Nordisk, Merck, BMS, Pfizer, AstraZeneca, Otsuka Pharmaceutical, Novartis and Sanofi, has signed deals with various AI drug discovery companies. PharmaCompass' compilation shows there are scores of molecules discovered by AI currently in discovery and developmental phases, demonstrating the technology's growing impact on pharmaceutical pipelines.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available) Novo, Lilly, BMS invest in AI partnerships; Recursion, Exscientia merge to create AI powerhouse With the transformative potential of AI becoming increasingly evident, we witnessed a slew of deals in the biopharma industry over the last six months. A significant deal in the AI drug discovery space was the merger of two leaders — Recursion and Exscientia — that took place in November last year. Exscientia is now a wholly-owned subsidiary of Recursion. The merger has created a global technology-enabled drug discovery leader with end-to-end capabilities. The merged entity has over 10 clinical and preclinical programs, and around 10 advanced discovery programs in the pipeline.  Apart from this merger, several large drugmakers have struck deals with AI drug discovery firms since September last year. For instance, in January this year, Valo Health and Novo Nordisk expanded their collaboration to discover and develop novel treatments for cardiometabolic diseases. This deal, valued at up to US$ 4.8 billion, aims to harness the power of AI and extensive human datasets. Building on their initial 2023 partnership, it will enable the development of up to 20 drug programs.  Similarly, Pfizer, which is already big on AI, extended its AI drug discovery pact with PostEra and also partnered IgnitionAI to enhance drug discovery — all within the last six months. And Novartis struck a drug discovery deal with Generate BioMedicines in September. Insilico Medicine has been actively forging partnerships. In January, Insilico entered a second exclusive global license agreement with Menarini Group for an AI-discovered preclinical asset targeting high unmet needs in oncology. Insilico also has a tie-up with Sanofi, dating back to 2022. In December 2024, AI Proteins announced a research collaboration and option agreement with BMS to design and optimize mini-proteins for therapeutic use. And in September, Eli Lilly joined hands with Genetic Leap to accelerate the development of genetic medicines. Lilly will leverage Genetic Leap’s RNA-targeted AI platform to generate oligonucleotide drugs against selected targets.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  AI leads to faster target identification; Insilico, BenevolentAI’s candidates in trials Computational biology, and especially AI, has fundamentally changed the drug discovery paradigm. The traditional method of drug discovery used to take 13 to 15 years, costing an average of US$ 2.5 billion in investment before a drug got approved and launched in the market. Additionally, less than 10 percent of candidates in phase 1 clinical trials used to end up getting approved by the US Food and Drug Administration (FDA). All that has begun to change. According to Khair ElZarrad, Director of the Office of Medical Policy within FDA’s Center for Drug Evaluation and Research, since 2016, FDA has received approximately 300 submissions that reference AI use as of May 2024. These submissions range from drug development, drug discovery, clinical research, clinical trials as well as post-market safety surveillance and manufacturing. Though we are yet to witness an AI-generated candidate translate into an approved therapy, target identification in drug discovery is visibly becoming a lot faster. This is the process that identifies specific molecules or pathways in the human body that are linked to a disease. The best example of dramatic acceleration of timelines is Insilico Medicine’s development of INS018_055, a candidate for idiopathic pulmonary fibrosis that entered phase 2 trials in June 2023. Using their AI platform PandaOmics, researchers at Insilico compressed target identification from years to just 18 months. Similarly, BenevolentAI successfully employed their AI platform to identify a new target for ulcerative colitis, leading to the development of BEN-8744, a candidate that has been in phase 1a clinical trials since August 2023.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  Oncology leads AI drug discovery market; Recursion shows how to repurpose drugs using AI The integration of AI in oncology research has been impactful, accounting for the largest revenue share (about 22.4 percent) in the AI drug discovery market in 2023. AI technologies have accelerated the discovery and development of new cancer treatments, bolstered personalized medicine approaches, and improved clinical trial designs in the arena of this complex disease.  Another promising application is drug repurposing, where AI can identify new therapeutic applications for existing drugs. Recursion Pharmaceuticals’ REC-2282 exemplifies this approach. This therapy is currently in phase 2/3 studies for neurofibromatosis type 2 (a genetic condition that causes tumors to grow along nerves). By repurposing compounds already vetted for safety, this strategy can bypass early-stage failures, reducing both time and cost compared to developing entirely new molecules. However, the use of AI in drug discovery is not without challenges. Exscientia’s EXS-21546, designed to treat solid tumors, entered phase 1/2 trials in 2020 but was discontinued in 2023 after modeling suggested that achieving a suitable therapeutic index would be difficult. Though this is a clinical failure, it highlights AI’s value in identifying potential failures earlier on in the development process, saving resources that would have otherwise been spent on later-stage trials.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  Our view The Covid-19 pandemic was a time when humanity felt the urgent need to speed up the process of drug discovery, testing and approvals. It also hastened the process of integrating AI into pharmaceutical research, leading to the launch of Covid vaccines in record time. Today, there is no looking back — AI is bringing about a paradigm shift in how drugs are discovered. With increasing reliance on AI, there is hope that drug discovery will be more accurate, efficient and less time and cost consuming.
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    Impressions: 1292

    https://www.pharmacompass.com/radio-compass-blog/ai-drug-discovery-market-to-grow-30-cagr-to-reach-us-35-bn-by-2034-novo-lilly-bms-forge-deals

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    13 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

    GLOBENEWSWIRE
    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

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    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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    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.

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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
    Not Confirmed
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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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    Not Confirmed
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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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    Not Confirmed
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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
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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

    DEALS_DEV arrow-down

    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
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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
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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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    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
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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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    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

    USA
    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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