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Country of origin : Argentina

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rituximab

Solution for injection 100mg, 500mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Argentina
GMP approvals
PICS
Unavailable markets
Pakistan
Manufacturer #16876
It is a biopharmaceutical company specializing in the research, development, production, and commercialization of vaccines and biopharmaceutical products of high complexity. With unique worldwide characteristics, the company carries out an innovative production model of strategic partnerships with national and international laboratories that allows: the transfer and availability of state-of-the-art technologies, autonomy in the production and supply of strategic products that previously had to be imported, the generation of new sources of employment with highly qualified professionals, the replacement of imports and the generation of important export potential.

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Rituximab Manufacturers

Rituximab is a biopharmaceutical medication that is primarily used to treat rheumatoid arthritis, as well as certain blood cancers, such as non-Hodkin's lymphoma and chronic lymphocytic leukemia. This medicine can also be used to treat certain types of blood vessel disease (such as granulomatosis with polyangiitis and microscopic polyangiitis) by reducing blood vessel swelling. Rituximab is also used to treat a skin disorder called vitiligo (pemphigus Vulgaris). It aids in the reduction of skin lesions. The following rituximab products are covered in this monograph: rituximab, rituximab-abbs, rituximab-arrx, and rituximab-pvvr. It is available in the form of injectable rituximab solutions in vials. Rituximab was developed by IDEC Pharmaceuticals and was the first therapeutic antibody to be approved for medical use in 1997. As of today, it is approved in and supplied to over 100 countries, has become one of the best-selling medicines worldwide, and is one of the pharmaceutical drugs that are included in the World Health Organization’s List of Essential Medicines required in a basic health system. Due to the drug’s expensive and complex manufacturing process, the rituximab market is populated and split between only a few large pharmaceutical manufacturers and suppliers. Until patent expiry in 2013, Roche, with its trade name drug MabThera was the only rituximab drug supplier in the market. Since then, suppliers Celltrion and Sandoz, and AryoGen have launched their trade name rituximab medications. Kids two years of age and older or adults can receive rituximab injection (Rituxan, Ruxience) in combination with other medications to treat granulomatosis with polyangiitis (Wegener's Granulomatosis) and microscopic polyangiitis, which are circumstances in which the immune system attacks its veins and blood vessels, causing damage to organs like the heart and lungs. In a phase 2 trial, patients with recurrent illness were given rituximab plus bendamustine (Treanda, Cephalon). With an ORR of 92 percent, this combination was determined to be quite successful. You may experience nausea, vomiting, headaches, dizziness, joint/muscle discomfort, weakness, or flushing. Due to the rapid killing of cancer cells, rituximab might induce adverse effects (tumor lysis syndrome). Your doctor may prescribe medicine and advise you to drink plenty of water to reduce your risk. If you have symptoms like low back/side discomfort (flank pain), evidence of renal problems (painful urination, pink/bloody urine, change in the volume of urine), or muscular spasms/weakness, call your doctor straight once. This prescription can induce anemia, reduce your body's capacity to fight an infection, and make bruising and bleeding more difficult. If anyone gets any of the symptoms, contact your doctor right away: Easy bruising/bleeding, black/tarry stools, vomit that resembles coffee grounds, signs of infection (such as a persistent sore throat, fever, or chills), unusual tiredness, pale skin. Rituximab is administered in a hospital setting by a drip into a vein. An intravenous infusion is what this is called. Typically, you'll begin treatment with two rituximab injections spaced two weeks apart. When your rituximab infusions start to wear off or to prevent a flare-up of your arthritis, you'll be given another one. It could be between from six months to a couple of years later.
The initial infusion takes about six hours on average. Inputs at a later time may take up to four hours. However, this is subject to change. Infusions are required by many people at least once a year. If you have vasculitis, you may need to see a doctor more frequently. While taking a b medication, you may have symptoms such as fever, shivering, chills, weariness, headache, or nausea, especially after the first dosage. You may be given steroids and paracetamol on the day of your rituximab infusion. Antihistamines may also be prescribed. Antihistamines are medications used to alleviate the symptoms of allergies or allergic responses. If you have a dip in blood pressure during the infusion, your doctor may advise you to cease taking any blood pressure-lowering medicines, known as antihypertensive drugs, for 12 hours before taking rituximab. Diuretics and vasodilators are two types of antihypertensive medications. You'll undergo blood tests in between infusions. A specialized doctor or nurse will also monitor your progress during therapy.

How does Rituximab work?

Rituximab is a monoclonal antibody that fights cancer. It targets a protein on the surface of leukemia and lymphoma cells called CD20. Rituximab binds to all CD20 proteins it encounters. The immune system's cells then select the designated cells and kill them. Inflammation is given out by the immune system to defend the body from pathogens. However, in rare cases, B-cells, a type of immune cell, generate unneeded inflammation, causing damage to the body's healthy tissue. Rituximab reduces inflammation, discomfort, edema, and joint injury by lowering the amount of these B-cells. Rituximab takes 2 to 6 weeks to start working. Rituximab does not cure the disease, and you may need to take it for several years to prevent relapses. Some humans have created low levels of specific antibodies in their bloodstream for a long time after receiving Rituximab (longer than 11 months). Infections occurred in several of the patients who had low antibody levels. People with significant conditions should not receive Rituximab.

The Cost of Rituximab

An online search for the wholesale price for sale of Rituximab for distributors will reveal a wide range of costs. Rituximab retail prices approximate to around 1200 EUR for a 500mg/50ml unit and 200-250 EUR for a 100mg/10ml unit of the drug.

Navigating our pharmaceutical marketplace

Being a global B2B pharmaceutical online marketplace, Pipelinepharma is structured to simplify pharmaceutical deals by providing you with an intuitive interface that is easy to engage with. The selection of Rituximab distributor’s offerings can be narrowed down with filters and easily weighed against one another according to medication prices and commercial terms. The advanced filters help you filter out the countries for this substance manufacturer and this substance Rituximab supplier that you are looking for. These also enable you to check the dossier status of this medicine and the GMP approvals of the different variants of Rituximab. Also, each manufacturer or supplier product description contains essential information about this substance, including clinical data, stability zones, countries where Rituximab is already registered. Manufacturers also have special and delivery terms.

Establishing commercial ties

If you are a pharmaceutical licensing company or a distributor, you can enter into deals or negotiations over these medicine offers with manufacturing companies after completing the free registration process and joining our online marketplace. This helps ensure that you conclude the pharmaceutical product deal at a reasonable cost and achieve one of the best cost/benefit ratios for your company while bypassing lengthy sourcing, negotiation, and order process. Once you have finalized a deal, you can look forward to a long-lasting business relationship with the manufacturers or Rituximab suppliers. This way, the marketplace allows you as a distributor to skip the process of shortlisting product manufacturers every time you are looking for in-licensing or distribution deals.

Quality Assurance

To keep up to the quality standards other than Good Manufacturing Practice approvals that this medicine manufacturers list has, we qualify their companies before they are onboarded on the platform. This allows us to screen Rituximab Manufacturers for the quality of the pharmaceutical products’ dossiers and protect against the risk of possible malpractices.

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