One vial of azacitidine 100mg injection holds 100 mg of azacitidine and 100 mg of mannitol, and nothing else. It is a lyophilized powder that hospital pharmacy staff reconstitute before a cycle, and it is one of the few oncology vials that can go either under the skin or into a vein. Torso Healthcare manufactures it for hospitals, oncology distributors, and franchise partners who want the vial under their own brand.

What is azacitidine 100mg injection?

Azacitidine 100mg injection is a lyophilized antineoplastic powder supplied in a single-dose 100 mg vial, reconstituted before use and given by subcutaneous injection or intravenous infusion to adults under oncology supervision. Azacitidine is a pyrimidine analog, an antimetabolite that works by causing DNA hypomethylation and by acting directly on abnormal cells in the bone marrow.

The mannitol in the vial is the only excipient, and it sits at 100 mg, matching the azacitidine milligram for milligram. That detail matters more than it looks, because hypersensitivity to any excipient is a contraindication, so a mannitol sensitivity rules the product out. Buyers comparing specification sheets should check that line alongside the rest of our oncology medicine manufacturers range.

Azacitidine 100 mg Inj Uses

Approved labeling names the conditions below for adults. They are listed here as product information for healthcare professionals and trade buyers, not as a recommendation for any patient:

• Intermediate-2 and high-risk myelodysplastic syndromes
• Chronic myelomonocytic leukemia with 10 to 29 percent marrow blasts
• Acute myeloid leukemia with 20 to 30 percent blasts and multi-lineage dysplasia, where a stem cell transplant is not indicated

Treatment runs in cycles, with a rest period between them, and the schedule belongs to the treating oncologist. No dosing schedule is published on this page. What the purchasing side needs to know is that cycles repeat, so demand for this vial is steady and predictable per patient rather than one time.

Subcutaneous or Intravenous From the Same Vial

Most oncology injectables offer one route. This one offers two, and each is prepared differently from the same 100 mg vial. Getting the preparation wrong wastes an expensive vial, so the numbers below are worth putting in front of pharmacy staff.

The subcutaneous route gives a thicker 25 mg per mL suspension, and a dose over 4 mL is split across two injection sites. The intravenous route gives a thinner solution that is diluted further into a sodium chloride or lactated Ringer bag and infused over several minutes. The tight 45-minute window on the intravenous route is the one that catches people out, because a prepared bag cannot wait for a delayed slot.

Azacitidine 100 mg Injection Side Effects

The effects reported most often involve the blood counts. Thrombocytopenia, neutropenia, leukopenia, and anemia are all listed as very common, along with febrile neutropenia, and they show up mainly in the first two cycles, which is why counts are checked before each cycle begins.

Other very common reactions include nausea, vomiting, constipation, diarrhea, injection site reactions, fever, fatigue, and pneumonia. Reports after marketing have added interstitial lung disease, tumor lysis syndrome, injection site necrosis, necrotizing fasciitis, and pyoderma gangrenosum.

Labeling also carries kidney and liver cautions. Renal toxicity, including renal tubular acidosis, has been reported rarely, so bicarbonate, creatinine, and urea are monitored. Progressive hepatic coma has been reported rarely in patients with low serum albumin and a heavy tumor burden. Serious hypersensitivity appears in about 0.25 percent of patients and stops treatment when it happens.

The product is contraindicated in pregnancy, in severe kidney impairment, in advanced malignant liver tumors, and in anyone hypersensitive to azacitidine or mannitol. Azacitidine is mutagenic in laboratory testing and carcinogenic in animals, so contraception is required during treatment and for three months afterward, and pharmacy staff handles it under cytotoxic precautions.

Storage, Handling, and Shelf Life

Unopened vials are stored below 25 degrees C and kept away from light until reconstitution. Because this is a cytotoxic product, the vial travels and is handled under the same precautions as the rest of our cytotoxic line, including gemcitabine 200mg injection and docetaxel injection. Reconstituted material follows the timings in the table above and is never held past them.

Azacitidine 100 mg Injection Price in India

The azacitidine 100 mg injection price is MRP ₹3,800 per vial. The vial holds 100 mg of azacitidine with 100 mg of mannitol and nothing else, so the figure is driven by how the product is made rather than by what goes into it.

Cytotoxic containment and the lyophilization cycle carry most of the cost, with release testing on top. Storage below 25°C keeps the supply chain simple, so no cold chain charge sits on top of the quote. Batch pricing then depends on the number of vials ordered. Send your monthly requirement for azacitidine 100 mg injection, with the pack you need and the destination market, and the team will come back with current rates.

Azacitidine 100 mg Injection Manufacturer in India

Torso Healthcare is a WHO GMP-certified manufacturer of injectables in India, with a dedicated approach to cytotoxic products inside our injectable manufacturing operation. Oncology buyers rarely want a single molecule, so this vial sits alongside a wider cytotoxic range that lets one supplier cover the list.

Through third-party manufacturing, the 100 mg vial reaches the market under your own brand name, carton, and artwork. A certificate of analysis travels with every batch, pack and carton options are built around your brand, and dispatch covers domestic and export markets.

Frequently Asked Questions

What does an azacitidine 100 mg vial contain?

Each single-dose vial holds 100 mg of azacitidine with 100 mg of mannitol, and mannitol is the only excipient. Because hypersensitivity to an excipient is a contraindication, a known mannitol sensitivity rules the product out for that patient.

Can azacitidine be given both under the skin and into a vein?

Yes. Approved labeling covers subcutaneous injection and intravenous infusion from the same vial. The two routes use different reconstitution volumes and have different time limits once prepared, so pharmacy staff follow the route decided for that patient.

How long does reconstituted azacitidine last?

A subcutaneous suspension holds for about one hour at 25 degrees C, or around 8 hours refrigerated. An intravenous dose is tighter, and administration has to finish within 45 minutes of reconstitution, so the bag is prepared close to the infusion slot.

Does azacitidine need cytotoxic handling precautions?

Yes. Azacitidine is an antineoplastic agent that is mutagenic in laboratory testing and carcinogenic in animal studies, so preparation and disposal follow standard cytotoxic handling practice in the hospital pharmacy.

Is this vial available for third-party and PCD supply?

Yes. Torso Healthcare supplies the 100 mg vial for third-party manufacturing and PCD franchise arrangements, with your brand name and artwork on the carton and full batch documentation, including a certificate of analysis, with each consignment.

To source azacitidine 100mg injection in bulk or under your own label, request a quote with your quantity and pack requirement, and Torso Healthcare will reply with current rates.

Composition, indications, handling, and safety details on this page follow the approved azacitidine datasheet.

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. Azacitidine is a prescription cytotoxic medicine and must be prescribed and administered only under qualified medical supervision.