Alkem Laboratories

VISIT THE VIRTUAL BOOTH, Contact Details

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 236 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

61 All APIs, 41 USDMF, 16 EU WC, 1 KDMF, 49 Listed APIs

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

FINISHED DOSAGE FORMULATIONS

358 FDF Dossiers, 358 FDA Orange Book

INSPECTIONS & REGISTRATIONS

11 FDA, 3 EDQM, 3 WHO-GMP, 4 GDUFA

Filters

Digital content

Create Content with PharmaCompass, ask us

INTERVIEW #SpeakPharma

[Sponsored by another company]

“Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient

Impressions: 5190

VLOG #PharmaReel

[Sponsored by another company]

Your Trusted Partner in Pharmaceutical Development

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies

In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding.

Impressions: 5984

NEWS #PharmaBuzz

[Sponsored by another company]

Alkem launches Kojiglo serum to manage facial hyperpigmentation

05 Feb 2025

// INDPHARMAPOST

Alkem Lab`s Generics Nimodipine Receives Approval in US

22 Jan 2025

// FDA

Alkem`s Generics Azilsartan, Chlorthalidone Receives Approval in US

21 Jan 2025

// FDA

Alkem Lab`s Generics Carbamazepine Receives Approval in US

14 Jan 2025

// FDA

Alkem Laboratories to sell Pithampur unit for Rs 149 crore

08 Jan 2025

// ECONOMICTIMES

Alkem Launches MediSamvad Digital Platform for Health Professionals

20 Dec 2024

// EXPRESSPHARMA

Contact Alkem Laboratories and get a quotation

Alkem Laboratories is a supplier offers 60 products (APIs, Excipients or Intermediates).

Find a price of Amlodipine Besylate bulk with DMF, WC offered by Alkem Laboratories

Find a price of Aripiprazole bulk with DMF, WC offered by Alkem Laboratories

Find a price of Duloxetine Hydrochloride bulk with DMF, WC offered by Alkem Laboratories

Find a price of Eluxadoline bulk with DMF, WC offered by Alkem Laboratories

Find a price of Esomeprazole Magnesium bulk with DMF, WC offered by Alkem Laboratories

Find a price of Fampridine bulk with DMF, WC offered by Alkem Laboratories

Find a price of Lansoprazole bulk with DMF, WC offered by Alkem Laboratories

Find a price of Mesalazine bulk with DMF, WC offered by Alkem Laboratories

Find a price of Rasagiline Mesylate bulk with DMF, WC offered by Alkem Laboratories

Find a price of Riluzole bulk with DMF, WC offered by Alkem Laboratories

Find a price of Rizatriptan Benzoate bulk with DMF, WC offered by Alkem Laboratories

Find a price of Sodium Oxybate bulk with DMF, WC offered by Alkem Laboratories

Find a price of Solriamfetol Hydrochloride bulk with DMF, WC offered by Alkem Laboratories

Find a price of Tapentadol bulk with DMF, WC offered by Alkem Laboratories

Find a price of Amlodipine bulk with DMF offered by Alkem Laboratories

Find a price of Apremilast bulk with DMF offered by Alkem Laboratories

Find a price of Azilsartan bulk with DMF offered by Alkem Laboratories

Find a price of Bempedoic Acid bulk with DMF offered by Alkem Laboratories

Find a price of Benzoyl Peroxide bulk with WC offered by Alkem Laboratories

Find a price of Canagliflozin bulk with DMF offered by Alkem Laboratories

Find a price of Cannabidiol bulk with DMF offered by Alkem Laboratories

Find a price of CAS 21409-26-7 bulk with DMF offered by Alkem Laboratories

Find a price of Dexmethylphenidate bulk with DMF offered by Alkem Laboratories

Find a price of Dimethyl Fumarate bulk with DMF offered by Alkem Laboratories

Find a price of Dronedarone Hydrochloride bulk with DMF offered by Alkem Laboratories

Find a price of Esketamine Hydrochloride bulk with DMF offered by Alkem Laboratories

Find a price of Esomeprazole Magnesium bulk with DMF offered by Alkem Laboratories

Find a price of Lanthanum Carbonate bulk with DMF offered by Alkem Laboratories

Find a price of Lisdexamfetamine Dimesylate bulk with DMF offered by Alkem Laboratories

Find a price of Lurasidone Hydrochloride bulk with DMF offered by Alkem Laboratories

Find a price of Methylphenidate Hydrochloride bulk with DMF offered by Alkem Laboratories

Find a price of Nebivolol bulk with DMF offered by Alkem Laboratories

Find a price of Paliperidone bulk with WC offered by Alkem Laboratories

Find a price of Quetiapine Hemifumarate bulk with DMF offered by Alkem Laboratories

Find a price of Rabeprazole bulk with DMF offered by Alkem Laboratories

Find a price of Ritalinic Acid bulk with DMF offered by Alkem Laboratories

Find a price of Tapentadol bulk with DMF offered by Alkem Laboratories

Find a price of Tolterodine Tartrate bulk with DMF offered by Alkem Laboratories

Find a price of Tolvaptan bulk with DMF offered by Alkem Laboratories

Find a price of EZETIMIBE USP bulk with DMF offered by Alkem Laboratories

Find a price of Lamotrigine bulk offered by Alkem Laboratories

Find a price of Olanzapine bulk offered by Alkem Laboratories

Find a price of Apixaban bulk offered by Alkem Laboratories

Find a price of Benzonatate bulk offered by Alkem Laboratories

Find a price of Bupropion Hydrochloride bulk offered by Alkem Laboratories

Find a price of Candesartan bulk offered by Alkem Laboratories

Find a price of Dabigatran Etexilate Mesylate bulk offered by Alkem Laboratories

Find a price of Dapagliflozin bulk offered by Alkem Laboratories

Find a price of Edoxaban Tosylate bulk offered by Alkem Laboratories

Find a price of Empagliflozin bulk offered by Alkem Laboratories

Find a price of Eslicarbazepine Acetate bulk offered by Alkem Laboratories

Find a price of Ezetimibe bulk offered by Alkem Laboratories

Find a price of Hydrochlorothiazide bulk offered by Alkem Laboratories

Find a price of Ivacaftor bulk offered by Alkem Laboratories

Find a price of Minoxidil bulk offered by Alkem Laboratories

Find a price of Mirabegron bulk offered by Alkem Laboratories

Find a price of Olmesartan Medoxomil bulk offered by Alkem Laboratories

Find a price of Sitagliptin Phosphate bulk offered by Alkem Laboratories

Find a price of Solifenacin Succinate bulk offered by Alkem Laboratories

Find a price of Ticagrelor bulk offered by Alkem Laboratories