Bendamustine 100 mg runs on a clock. The powder has to dissolve within five minutes, the dose has to reach the infusion bag within thirty minutes, and the prepared bag has its own limit after that. Miss any of them and a costly vial is written off. Torso Healthcare manufactures the lyophilized 100 mg vial for oncology distributors, hospitals, and franchise partners who want it under their own brand.

What is bendamustine 100 mg?

Bendamustine 100 mg is a single-dose vial of bendamustine hydrochloride supplied as a lyophilized powder, reconstituted and diluted before being infused into a vein under oncology supervision. The vial carries 170 mg of mannitol alongside the active, and mannitol is the only excipient, which matters because hypersensitivity to it is a contraindication in its own right. Purchase records shorten the name in several ways, so the same pack turns up as inj bendamustine, inj bendamustine 100 mg, or plain bendamustine injection.

The reconstituted solution is acidic, sitting at a pH between 2.5 and 3.5, and the vial carries no antimicrobial preservative. Both facts shape how pharmacy handles it, and they put the product in the same careful bracket as the rest of our oncology manufacturing list.

Bendamustine Mechanism of Action

Bendamustine is an alkylating drug, a bifunctional mechlorethamine derivative, but it carries something most alkylators do not: a purine-like benzimidazole ring built into the same molecule. That hybrid structure is the reason it gets described as sitting between two drug families rather than squarely inside one.

What it does is form crosslinks between the two strands of DNA, which the cell cannot repair, leading to cell death. One detail separates it from much of the cytotoxic shelf. It acts on resting cells as well as dividing ones, where many agents only reach cells actively going through division. Labeling is candid that the full mechanism is still not completely understood.

Bendamustine 100 mg Uses

Bendamustine uses are narrower than much of the oncology shelf around it. Approved bendamustine injection uses cover two conditions for intravenous treatment, stated here as product information for healthcare professionals and trade buyers rather than as a recommendation for any patient:

• Chronic lymphocytic leukemia
• Indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen

Both are hematology indications rather than solid tumor ones, so the buyers who stock this vial tend to be supplying hematology day units and transplant centers rather than general oncology wards. Courses repeat in cycles, which makes demand per patient steady and forecastable.

Three Time Limits That Decide Whether the Vial Survives

Most supplier listings stop at the strength. The preparation window is where money is actually lost, and labeling is specific about it.

Sterile water for injection is the only diluent used for the vial itself. The dose then goes into 0.9 percent sodium chloride, or into 2.5 percent dextrose with 0.45 percent sodium chloride, and the finished bag has to land between 0.2 and 0.6 mg per mL. Too dilute or too concentrated, and the preparation is outside the label.

A labeled hypothetical, written as an illustration rather than a case report: a day unit reconstitutes the vial while the patient is still in the waiting area, the chair runs late, and the thirty minute transfer window closes before the bag is made up. The dose is discarded, and the slot is lost. Scheduling the preparation against the chair, rather than the clinic list, is what prevents that.

Bendamustine Dose and Administration

Dosing is calculated on body surface area and set by the treating hematologist, so no schedule appears on this page. Two points matter for the supply and pharmacy side. The infusion itself runs over about 30 to 60 minutes, depending on which indication is being treated, and treatment is given on two consecutive days at the start of each cycle, with the cycle length also differing by indication.

Doses are delayed or reduced when blood counts fall, which is common enough that a planned course and a delivered course are not always the same thing. Buyers’ forecasting consumption should allow for that.

Bendamustine 100 mg Side Effects

Reported bendamustine side effects differ sharply between the two indications, which is unusual enough to be worth stating rather than averaging. In chronic lymphocytic leukemia trials, fever was reported in about 24 percent of patients, nausea in 20 percent, and vomiting in 16 percent. In the lymphoma setting, the figures are much higher, with nausea around 75 percent, fatigue 57 percent, vomiting 40 percent, diarrhea 37 percent, and fever 34 percent.

Blood count changes sit underneath both sets, covering low lymphocytes, low white cells, low platelets, low neutrophils, and anemia. Myelosuppression can be severe enough to require dose delays, and complications from it have been fatal.

Labeling carries several further warnings. Infections including pneumonia and sepsis have occurred. Infusion reactions and anaphylaxis can be severe, and notably tend to appear in later cycles rather than the first, so vigilance does not relax as the course goes on. Tumor lysis syndrome can lead to acute kidney failure. Serious skin reactions have been reported, including a case of toxic epidermal necrolysis. Second cancers, including myelodysplastic syndrome and acute myeloid leukemia, have been reported after treatment, and the drug can harm a developing baby. The full list of bendamustine adverse effects sits in approved labeling, and the treating team reviews it before each cycle.

Bendamustine Brand Name and Own Label Supply

Treanda is the originator brand, and Indian suppliers market the molecule under their own labels, with names such as Bendit in circulation. Contract manufacturing puts the same 100 mg vial on the market under your brand name, carton, and artwork instead of an existing label. Hematology and oncology buyers order across a list, so partners commonly pair it with products such as gemcitabine injection and docetaxel 120 mg. Our own brand name is TSOBEND-100 Injection.

Bendamustine 100 mg Price in India

The bendamustine injection price is MRP ₹3,415 per vial. Vial size is what moves it, because the 25 mg and 100 mg presentations use different glass and fill volumes, so the bendamustine cost per vial does not scale evenly between the two.

Cytotoxic handling adds to the base, since containment, dedicated areas, and operator protection apply throughout, and lyophilization sits on top of that. Light protection is part of the pack specification rather than an extra, because the vial stays in its outer carton. Batch pricing then depends on the number of vials ordered. Send your monthly requirement for bendamustine 100 mg, with the vial sizes and the destination market, and the team will come back with current rates.

Bendamustine 100 mg Manufacturers in India

Choosing a bendamustine manufacturer usually comes down to documentation and batch consistency rather than price alone. Torso Healthcare is a WHO GMP-certified maker of injectables in India, handling cytotoxic products under dedicated precautions alongside the wider oncology range, including carboplatin 600 mg. Every batch ships with a certificate of analysis, carton and pack options are built to your brand, and dispatch covers domestic and export markets.

Frequently Asked Questions

How quickly must bendamustine be used after reconstitution?

The powder should dissolve within five minutes, and the dose must be transferred to the infusion bag within thirty minutes of reconstitution. The prepared bag is then given within three hours at room temperature, or within 24 hours if it is kept refrigerated.

Is bendamustine an alkylating agent or a purine analog?

Structurally, it carries elements of both. Labeling describes it as an alkylating drug, a bifunctional mechlorethamine derivative, that also contains a purine-like benzimidazole ring. That hybrid structure is why it is often discussed separately from standard alkylating agents.

Which diluent is used to reconstitute bendamustine 100 mg?

Sterile water for injection, 20 mL for the 100 mg vial, which gives a concentration of 5 mg per mL. The measured dose is then diluted into a 500 mL bag of sodium chloride, or dextrose with sodium chloride, to a final strength between 0.2 and 0.6 mg per mL.

Does the vial contain a preservative?

No. The product contains no antimicrobial preservative, which is one reason the preparation time limits are tight and why any unused portion is discarded rather than kept for a later dose.

Can bendamustine be supplied under our own brand name?

Yes. The 100 mg vial is available for third-party manufacturing and PCD franchise supply, carrying your brand name and artwork, with batch documentation including a certificate of analysis sent with each consignment.

Hospitals and distributors sourcing bendamustine 100 mg in bulk, or building their own label around it, can share their order details, and Torso Healthcare will respond with current rates and pack options.

Composition, indications, preparation limits, and safety details on this page follow the FDA bendamustine label.

Disclaimer: This page is intended for pharmaceutical businesses, trade buyers, and healthcare professionals as product reference information only. It is not an advertisement to the public, not medical advice, and not a recommendation for treatment. Bendamustine is a prescription cytotoxic medicine and must be prescribed and administered only under qualified medical supervision.