Please Wait
Applying Filters...
menu
    • menu
    Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Virtual Booth

    Contact Supplier

    SPI Pharma has been solving formulation challenges using superior functional materials.

    Virtual Booth

    Contact Supplier

    xyz-pharma-m-2024-10-07

    Virtual Booth

    Contact Supplier

    Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.

    Virtual Booth

    Contact Supplier

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

    Virtual Booth

    Contact Supplier

    xyz-pharma-m-2024-10-07

    Virtual Booth

    Contact Supplier

    Menu

    Symed Labs

    EVENTS

    • Webinars & Exhibitions

    PRESENTATION(s)

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Filters

    clear-filterReset all filters
    Left Arrow
    Right Arrow

    Digital content

    Create Content with PharmaCompass, ask us

    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    This week, SpeakPharma interviews four senior executives of LGM Pharma — Shailesh Vengurlekar (Senior VP, Quality and Regulatory Affairs), Deepak Thassu (Senior VP, R&D and Regulatory Submission), Selwyn Lustman (Senior VP, Global Sourcing and Procurement), and Mike Stenberg (VP, Business Development). The four VPs talk about expansion in manufacturing capabilities of the Florida-based contract development and manufacturing organization (CDMO), expertise that makes LGM a strong partner and the criteria it adopts while selecting its suppliers.  HIGHLIGHTS// expansion in manufacturing capabilities/ expertise that makes LGM a strong partner/ criteria for selecting its suppliers LGM Pharma recently invested heavily in expanding its CDMO capabilities by 50 percent. Can you share why offering standalone analytical testing services is important to LGM Pharma’s growth strategy? How does it benefit your clients? Vengurlekar: This recent expansion in CDMO capabilities is part of LGM Pharma’s growth strategy that lays importance on diversification. One key area of this diversification is the offering of standalone Analytical Testing Services (ATS). This service plays a crucial role in supporting our clients by providing them with greater flexibility and reliability. LGM Pharma is already a well-established leader in the API supply chain. We have now identified a significant need in the market and are now serving compounding pharmacies, including 503A and 503B facilities. These pharmacies not only require high-quality, GMP-compliant APIs, but also need a trusted, compliant, and capable laboratory to analyze both their APIs and compounded products. Recognizing this opportunity to further support our clients, LGM Pharma has expanded into ATS. We have witnessed tremendous growth since we’ve launched these services. By offering ATS under a separate legal entity — LGM Pharma Solutions — we are able to provide an additional layer of flexibility to our clients. This structure eliminates any conflict of interest. While LGM Pharma LLC handles API supply, LGM Pharma Solutions focuses on delivering top-tier ATS, all under the same LGM Pharma umbrella. This setup enhances trust and allows our clients to work with us more seamlessly. HIGHLIGHTS// diversified into standalone ATS/ well-established leader in API supply chain/ serving compounding pharmacies/ offering APIs and ATS under different legal entities. While suppositories offer clear advantages for certain medications, can you describe how LGM Pharma plans to leverage its expertise in this area to address specific unmet needs in the growing women’s health market? Thassu: We’re taking a dual approach to enhance both our R&D and manufacturing capabilities. First, we’ve introduced a new semi-automatic machine that allows us to produce smaller batches more efficiently. This is particularly important for the suppository segment, where demand doesn’t require large-scale production. The new system enables quicker adjustments to the manufacturing process, providing us with greater flexibility of producing small batches. Second, many of the materials we handle in the women’s health sector are sensitive to heat, light, and oxygen. To address this, we’re upgrading our facility to accommodate these specialized requirements. This ensures we can develop and manufacture products while maintaining the integrity of heat-, light-, and oxygen-sensitive ingredients. Additionally, we’re working closely with clients to prepare for various technical challenges. Whether it’s processing homeopathic ingredients or handling delicate fermentation-based materials, which are highly sensitive to both light and heat, our team has upgraded its skills and equipment to manage these complexities. From technology advancements in manufacturing to specialized handling conditions and improved technical expertise, we’ve made significant strides to ensure we can meet the evolving needs of our clients and their products. HIGHLIGHTS// dual approach to enhance R&D and manufacturing capabilities/ upgrading facilities to accommodate specialized requirements/ working with clients to address challenges. The pandemic underscored supply chain problems. Can you detail the specific criteria LGM Pharma uses while selecting suppliers for its manufacturing processes? Lustman: LGM looks at many facets of a manufacturer before proceeding to approve them for a specific project. We start by checking their regulatory history with the US Food and Drug Administration (FDA) and other authorities. We try to find out if they have received any warning letters. What is their inspection history? Have they received NAIs (no action indicated) and VAIs (voluntary action indicated)? We further investigate the company’s overall business status — we need to know that they are a stable partner to work with in the long term. Manufacturers are then assessed for their overall technology and the number of employees working in various fields, such as R&D, quality control, quality assurance, regulatory affairs, manufacturing, and the educational levels of these employees. Once we have established that the manufacturer is a potential partner, we check their status for a particular project. We look at their advantages, and whether they have a non-infringing route of synthesis (ROS) that will allow early launch. Are they developing a second process that will be more competitive in pricing? And, does the manufacturer have the necessary capacity and/or spare capacity for the project that we are assessing? We need to know whether the drug master file (DMF) has been registered, the current batch size, and the potential for increase in batch size. Pricing is a key indicator — we need to know whether the pricing of the manufacturer is competitive or not, and if the manufacturer will be able to compete in the future as the project matures. LGM always assesses for quality, price, and delivery. Goods must be of the correct quality, at the right price, with delivery time as desired, in order to meet commercial needs. HIGHLIGHTS// investigate various facets of manufacturer before approving them for a project/ look at advantages, non-infringing ROS/ assess for quality, price, delivery Can you highlight specific capabilities and experiences LGM Pharma possesses that make it a strong partner for companies developing antibody-drug-conjugates (ADCs)? Stenberg: ADCs are often peptides linked with small molecules. However, they may also be peptides linked with oligonucleotides. Regardless, LGM can help manage the supply chain associated with the components that are used in the conjugation of the ADC. LGM has extensive experience, and an extensive network around sourcing and managing the supply chain associated with ADC components. LGM’s experience and capabilities extend to sourcing peptides, small molecules or oligonucleotides used in the conjugation process. Additionally, given our deep relationships in the supply chain aspect of this process, LGM may also be able to identify partners who can help with the conjugation process itself. HIGHLIGHTS// extensive experience, network around sourcing, managing supply chain associated with ADC components / identify partners that can help with conjugation process

    Impressions: 455

    subscribeSubscribe

    https://www.pharmacompass.com/speak-pharma/lgm-pharma-has-made-significant-strides-in-meeting-the-evolving-needs-of-its-clients

    #SpeakPharma With LGM Pharma
    09 Nov 2024
    Share info Share

    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    This year has seen pivotal advancements in medical innovation. The US Food and Drug Administration (FDA) has approved several groundbreaking therapies that promise to transform patient care across multiple therapeutic areas.Some of the therapies approved have revolutionary delivery mechanisms, while others are first-in-class treatments for previously unaddressed conditions. This week, PharmaCompass brings you a compilation of new pathbreaking approvals of 2024, including advancements in neurology, chronic conditions, mental health conditions, and innovative solutions for various other ailments.Lilly, Alpha Cognition, BMS transform neurological care with new Alzheimer’s, schizophrenia drugsThe neurological treatment landscape saw several major breakthroughs in 2024, particularly in the treatment of Alzheimer’s disease (AD). Eli Lilly’s Kisunla represents a significant advancement in treating early, symptomatic AD. Following decades of failed efforts, Kisunla’s approval, along with that of Eisai-Biogen’s Leqembi last year, marks a turning point in addressing AD.The drug works by targeting and clearing beta amyloid plaque from the brain, thereby attacking the disease’s underlying pathology, rather than just managing symptoms. Administered as an infusion every four weeks, Kisunla’s Medicare coverage makes it accessible to patients in the US who desperately need new treatment options. Alpha Cognition’s Zunveyl emerged as a promising new oral treatment for mild-to-moderate Alzheimer’s-related dementia. Only the second oral AD treatment approved by the FDA in over a decade, Zunveyl is a prodrug, or a biologically inactive compound that can be metabolized by the body to produce a drug. It remains inactive as it passes through the stomach and enhances cholinergic function in the brain.Perhaps one of the most exciting breakthroughs of 2024 was Bristol-Myers Squibb’s Cobenfy. This revolutionary antipsychotic medication for schizophrenia represents the first novel approach to treatment since the 1950s. Unlike traditional antipsychotics that target dopamine receptors, Cobenfy works through cholinergic receptors, offering new hope to patients who struggle with the side effects of conventional treatments.Traditional antipsychotics have been associated with several mild and serious side effects such as weight gain, feeling unmotivated and sluggish, high rates of cardiac disease, and even early death. Cobenfy’s innovative mechanism of action has generated excitement in the medical community. Experts project Cobenfy to bring in US$ 7.5 billion in peak annual sales, thereby validating BMS’ recent, US$ 14-billion acquisition of Karuna Therapeutics.Verona, Sanofi’s drugs revolutionize COPD care; Madrigal’s Rezdiffra offers hope to MASH patients The landscape of chronic obstructive pulmonary disease (COPD) treatment saw remarkable advances in 2024. Verona Pharma’s Ohtuvayre brings the first new mechanism of action in over two decades for COPD treatment. This dual-action, inhaled medication serves as both a bronchodilator and an anti-inflammatory agent, offering a comprehensive approach to symptom management.Adding to this progress, Sanofi and Regeneron’s Dupixent achieved a historic milestone by becoming the first biologic approved for treating COPD. Dupixent is Sanofi’s best-selling drug. It is poised to cross over € 21 billion (US$ 23.5 billion) in sales by 2030, with COPD likely to contribute US$ 2.9 billion, predict analysts. Over 390 million people are living with COPD worldwide.In the field of liver disease, Madrigal Pharmaceuticals’ Rezdiffra became the first FDA-approved treatment for metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring. This approval represents a breakthrough in a field that has been notorious for being a graveyard for failed programs. Rezdiffra offers hope to patients with this common liver condition, which primarily affects those with obesity or type 2 diabetes. The American Liver Foundation has termed this approval a “game-changing” moment in hepatology.For the rare disease community, Ipsen’s Iqirvo emerged as the first new medicine approved in nearly a decade for primary biliary cholangitis (PBC). This first-in-class peroxisome proliferator-activated receptor (PPAR) agonist offers new hope for the approximately 100,000 Americans affected by this condition, particularly women aged 30 to 60 years.A significant breakthrough for patients with hypoparathyroidism came with the approval of Ascendis’ Yorvipath, making it the only treatment for hypoparathyroidism in adults. By directly addressing the underlying hormone deficiency, Yorvipath helps stabilize calcium levels in the blood, reducing the treatment burden associated with managing symptoms through calcium and vitamin D supplements alone.In the realm of pulmonary medicine, Merck’s Winrevair emerged as the first new therapy for pulmonary arterial hypertension (PAH) in over a decade. As the first approved activin-signaling inhibitor therapy, Winrevair represents a novel approach to treating this rare but severe condition that doctors call a “ticking time bomb”. The drug is the first treatment that targets the underlying cause of the lung condition, which typically leads to death within a decade of diagnosis.ARS Pharma launches nasal spray alternative to EpiPen, Eicos introduces med for severe frostbiteLeading the charge in innovative drug delivery is ARS Pharma’s Neffy, the first-ever nasal spray alternative to the EpiPen for treating severe allergic reactions. This groundbreaking advancement represents the first major innovation in anaphylaxis treatment in over a decade. For children and individuals with needle phobia, this nasal spray format addresses one of the most significant barriers to timely treatment of allergic emergencies. Speaking of emergency medicine, Eicos Sciences’ Aurlumyn made history as the first FDA-approved treatment for severe frostbite. This approval fills a critical gap in emergency care, offering a medical intervention that could prevent the need for amputation in severe cases.The cardiovascular space saw its first oral anti-hypertensive therapy that works through a new therapeutic pathway in almost 40 years. Idorsia’s Tryvio is a treatment for hypertension that offers new hope to patients whose blood pressure remains inadequately controlled on existing medications. Idorsia expects millions of patients to benefit from it.Our view This year, the pharmaceutical industry has taken a remarkable leap forward by addressing some of healthcare’s most challenging conditions. Treatments like BMS’ Cobenfy for schizophrenia and Madrigal’s Rezdiffra for MASH demonstrate the industry’s growing ability to translate science into practical therapies. With the growing use of artificial intelligence in the drug industry, we hope that these approvals are just a precursor to a bevy of pathbreaking therapies in the years to come. 
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 559

    https://www.pharmacompass.com/radio-compass-blog/medical-breakthroughs-in-2024-alzheimer-s-schizophrenia-copd-mash-see-pathbreaking-treatments

    #Phispers by PHARMACOMPASS
    14 Nov 2024
    Share Share

    NEWS #PharmaBuzz

    [Sponsored by another company]read-more
    read-more
    Linezolid : Symed Labs, Hetero USA vs. Amneal Pharmaceuticals
    Linezolid : Symed Labs, Hetero USA vs. Amneal Pharmaceuticals

    15 Sep 2018

    // PATENT LITIGATION

    https://insight.rpxcorp.com/litigation_documents/13058146

    PATENT LITIGATION
    15 Sep 2018
    Share Share
    Linezolid : Symed Labs & Hetero USA v. Amneal Pharmaceuticals
    Linezolid : Symed Labs & Hetero USA v. Amneal Pharmaceuticals

    06 Sep 2018

    // PATENT LITIGATION

    https://www.pharmacompass.com/pdf/news/linezolid-symed-labs-hetero-usa-v-amneal-pharmaceuticals-1536300881.pdf

    PATENT LITIGATION
    06 Sep 2018
    Share Share
    Contact Symed Labs and get a quotation

    Symed Labs is a supplier offers 88 products (APIs, Excipients or Intermediates).

    Find a price of Brimonidine Tartrate bulk with DMF, CEP offered by Symed Labs

    Find a price of Deferasirox bulk with DMF, CEP offered by Symed Labs

    Find a price of Hydroxyzine Dihydrochloride bulk with DMF, CEP offered by Symed Labs

    Find a price of Ketorolac Trometamol bulk with DMF, CEP offered by Symed Labs

    Find a price of Levocetirizine Dihydrochloride bulk with DMF, CEP offered by Symed Labs

    Find a price of Meclizine Hydrochloride bulk with DMF, CEP offered by Symed Labs

    Find a price of Rivaroxaban bulk with DMF, CEP offered by Symed Labs

    Find a price of Tizanidine HCl bulk with DMF, CEP offered by Symed Labs

    Find a price of Sertraline Hydrochloride bulk with DMF, CEP offered by Symed Labs

    Find a price of Amisulpride bulk with CEP offered by Symed Labs

    Find a price of Bilastine bulk with DMF offered by Symed Labs

    Find a price of Carvedilol bulk with CEP offered by Symed Labs

    Find a price of Dronedarone Hydrochloride bulk with DMF offered by Symed Labs

    Find a price of Eszopiclone bulk with DMF offered by Symed Labs

    Find a price of Lanthanum Carbonate bulk with DMF offered by Symed Labs

    Find a price of Linezolid bulk with DMF offered by Symed Labs

    Find a price of Meprobamate bulk with DMF offered by Symed Labs

    Find a price of Ondansetron Hydrochloride bulk with CEP offered by Symed Labs

    Find a price of Phentermine Hydrochloride bulk with DMF offered by Symed Labs

    Find a price of Prucalopride Succinate bulk with DMF offered by Symed Labs

    Find a price of Racecadotril bulk with CEP offered by Symed Labs

    Find a price of Tapentadol bulk with CEP offered by Symed Labs

    Find a price of Carbinoxamine bulk with DMF offered by Symed Labs

    Find a price of Ezetimibe bulk with DMF offered by Symed Labs

    Find a price of Hydroxychloroquine Sulphate bulk with DMF offered by Symed Labs

    Find a price of Hydroxyzine Pamoate bulk with DMF offered by Symed Labs

    Find a price of Iloperidone bulk with DMF offered by Symed Labs

    Find a price of Iron Sucrose bulk with DMF offered by Symed Labs

    Find a price of Iron Sucrose bulk offered by Symed Labs

    Find a price of Modafinil bulk with DMF offered by Symed Labs

    Find a price of Otilonium Bromide bulk with DMF offered by Symed Labs

    Find a price of Vortioxetine Hydrobromide bulk with DMF offered by Symed Labs

    Find a price of BILASTINE (FORM-I) bulk with DMF offered by Symed Labs

    Find a price of Amisulpride, Process-2, Symed Labs Limited Unit-II, 2ASP bulk with CEP offered by Symed Labs

    Find a price of Agomelatine bulk offered by Symed Labs

    Find a price of Cinitapride Hydrogen Tartrate bulk offered by Symed Labs

    Find a price of Dapoxetine Hydrochloride bulk offered by Symed Labs

    Find a price of Epalrestat bulk offered by Symed Labs

    Find a price of Gemfibrozil bulk offered by Symed Labs

    Find a price of Hydroxyzine Dihydrochloride bulk offered by Symed Labs

    Find a price of Itopride Hydrochloride bulk offered by Symed Labs

    Find a price of Levosulpiride bulk offered by Symed Labs

    Find a price of Mosapride Citrate bulk offered by Symed Labs

    Find a price of Pregabalin bulk offered by Symed Labs

    Find a price of Sibutramine Hydrochloride bulk offered by Symed Labs

    Find a price of Tapentadol Phosphate bulk offered by Symed Labs

    Find a price of Thalidomide bulk offered by Symed Labs

    Find a price of Tofisopam bulk offered by Symed Labs

    Find a price of Abacavir bulk offered by Symed Labs

    Find a price of Apixaban bulk offered by Symed Labs

    Find a price of Baclofen bulk offered by Symed Labs

    Find a price of Brivaracetam bulk offered by Symed Labs

    Find a price of Capecitabine bulk offered by Symed Labs

    Find a price of Carvedilol Phosphate bulk offered by Symed Labs

    Find a price of Clindamycin Palmitate bulk offered by Symed Labs

    Find a price of Dabigatran Etexilate Mesylate bulk offered by Symed Labs

    Find a price of Dapagliflozin bulk offered by Symed Labs

    Find a price of Dolutegravir Sodium bulk offered by Symed Labs

    Find a price of Edoxaban Tosylate bulk offered by Symed Labs

    Find a price of Empagliflozin bulk offered by Symed Labs

    Find a price of Ferric Carboxymaltose bulk offered by Symed Labs

    Find a price of Ferric Citrate bulk offered by Symed Labs

    Find a price of Ferric Maltol bulk offered by Symed Labs

    Find a price of Flibanserin bulk offered by Symed Labs

    Find a price of Glycopyrronium Bromide bulk offered by Symed Labs

    Find a price of Idrocilamide bulk offered by Symed Labs

    Find a price of Iron Sorbitol Citrate bulk offered by Symed Labs

    Find a price of Labetalol Hydrochloride bulk offered by Symed Labs

    Find a price of Lacosamide bulk offered by Symed Labs

    Find a price of Lamivudine bulk offered by Symed Labs

    Find a price of Linagliptin bulk offered by Symed Labs

    Find a price of Lopinavir bulk offered by Symed Labs

    Find a price of Losartan Potassium bulk offered by Symed Labs

    Find a price of Olmesartan Medoxomil bulk offered by Symed Labs

    Find a price of Relugolix bulk offered by Symed Labs

    Find a price of Rimegepant Sulfate bulk offered by Symed Labs

    Find a price of Ritonavir bulk offered by Symed Labs

    Find a price of Selexipag bulk offered by Symed Labs

    Find a price of Sitagliptin Phosphate bulk offered by Symed Labs

    Find a price of Tafamidis bulk offered by Symed Labs

    Find a price of Tamsulosin bulk offered by Symed Labs

    Find a price of Telmisartan bulk offered by Symed Labs

    Find a price of Tenofovir Disoproxil Fumarate bulk offered by Symed Labs

    Find a price of Ticagrelor bulk offered by Symed Labs

    Find a price of Valsartan bulk offered by Symed Labs

    Find a price of Vibegron bulk offered by Symed Labs

    Find a price of Vilazodone bulk offered by Symed Labs

    Find a price of Vonoprazan Fumarate bulk offered by Symed Labs