Healthy Inc > Blog > Immunosuppressant exporter Mumbai
Posted on:

Is Azathioprine 50 mg a steroid tablet?

In the pharmaceutical industry, Azathioprine 50 mg is classified as an immunosuppressant and a purine antimetabolite.

As a pharmacist and manufacturer, I can clarify a common clinical point: Azathioprine is NOT a steroid. However, it is very frequently used as a “Steroid-Sparing Agent.” This means it is given to patients so that their doctor can reduce (taper) the dose of actual steroids (like Prednisolone), thereby avoiding long-term steroid side effects.

At your WHO-GMP facility in Mumbai, you would classify this under the “Immunology” or “Specialty Chronic Care” segment.

Key Differences: Azathioprine vs. Steroids

Feature Azathioprine 50 mg Steroids (e.g., Prednisolone)
Drug Class Immunosuppressant (Antimetabolite) Corticosteroid (Hormonal)
Onset of Action Slow: Takes 6 to 12 weeks to work. Fast: Works within hours or days.
Mechanism Inhibits DNA synthesis in immune cells. Reduces inflammation via gene expression.
Long-term Use Generally safer for long-term maintenance. High risk of bone loss, weight gain, and diabetes.

Mechanism of Action: The DNA “Saboteur”

Azathioprine works by preventing the overproduction of the white blood cells (T-cells and B-cells) that cause autoimmune attacks.

Prodrug Conversion: Once ingested, it is rapidly converted into 6-mercaptopurine (6-MP).

Purine Mimicry: It mimics the natural “purines” that the body uses to build DNA.

DNA Disruption: When the immune cells try to multiply, they mistakenly use the Azathioprine metabolite. This “sabotages” the DNA synthesis, stopping the cells from replicating and calming the immune response.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai, Azathioprine is a high-value “Specialty” product:

  • Technical Monitoring (TPMT): As a pharmacist, you know that some patients lack the enzyme (TPMT) needed to break down this drug, which can lead to toxicity. Including a note about “TPMT testing” on your digital platform demonstrates extreme technical competence to international B2B buyers.

  • Coating Technology: Azathioprine is a cytotoxic substance. At our facility, we ensure high-quality film-coating to prevent dust exposure for healthcare workers and to ensure the tablet remains stable until it reaches the gut.

  • Stability & Packaging: It is highly sensitive to light (photolabile). We utilize Amber-colored PVC/PVDC or Alu-Alu blister packaging to ensure a 36-month shelf life, which is a critical USP for export to tropical regions.

  • Dossier Support: Because it is used in transplants and severe autoimmune cases, we provide full CTD/eCTD Dossiers to support your firm in bidding for specialized hospital tenders.

Azathioprine Tablets

Posted on:

What is Tacrolimus 1mg capsules used for?

In the pharmaceutical industry, Tacrolimus 1 mg is a powerful Calcineurin Inhibitor and a critical immunosuppressant. As a pharmacist and manufacturer, I view Tacrolimus as a “narrow therapeutic index” drug, meaning the dosage must be incredibly precise to prevent organ rejection while avoiding toxicity.

Primary Clinical Uses

  • Organ Transplant Rejection Prophylaxis: It is a cornerstone therapy for patients who have received kidney, liver, or heart transplants. It prevents the patient’s immune system from attacking and rejecting the new organ.

  • Autoimmune Disorders (Off-label): Occasionally used in severe cases of refractory rheumatoid arthritis, psoriasis, or lupus nephritis that do not respond to standard treatments.

  • Graft-versus-Host Disease (GVHD): Used in bone marrow or stem cell transplant patients to prevent the donor’s immune cells from attacking the recipient’s body.

Mechanism of Action: T-Cell Suppression

Tacrolimus works by silencing the “soldiers” of the immune system—the T-lymphocytes.

Intracellular Binding: Once inside the T-cell, Tacrolimus binds to a specific protein called FK-binding protein 12 (FKBP12).

Calcineurin Inhibition: This complex then binds to and inhibits Calcineurin, a calcium-dependent phosphatase enzyme.

Signal Blockage: By inhibiting calcineurin, the drug blocks the movement of a transcription factor (NF-AT) into the cell nucleus.

Cytokine Suppression: This prevents the production of Interleukin-2 (IL-2) and other cytokines. Without IL-2, T-cells cannot multiply or attack the transplanted organ.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your WHO-GMP facility in Mumbai, the 1 mg capsule involves high-level technical challenges:

  • Bioequivalence is Key: Because Tacrolimus has a narrow therapeutic window, your 1 mg generic must be perfectly bioequivalent to the innovator (Prograf). Even a slight variation in absorption can lead to organ rejection.

  • Hygroscopic Nature: Tacrolimus API is highly sensitive to moisture. In our Mumbai facility, we utilize Alu-Alu blister packaging or specialized desiccant-lined bottles to ensure a 24-to-36-month shelf life, especially for export to Zone IVb climates.

  • Handling Potent Compounds: As a manufacturer, you know that Tacrolimus is a potent drug. Production requires dedicated AHU (Air Handling Unit) systems and strict containment protocols to prevent cross-contamination in the factory.

  • Dossier Support: This is a high-value, life-saving medication. We provide full CTD/eCTD Dossiers with rigorous “Level B” or “Level C” dissolution data to help you register this in regulated markets.

Tacrolimus Tablets

 

Add to cart