GENERIC NAME OF THE MEDICINAL PRODUCT:

(A) Anidulafungin for Injection 100mg
(B) Anidulafungin for Injection 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1) Anidulafungin for Injection 100mg
A) Each vial contains:
Anidulafungin…………….………………………100mg
Tartaric Acid USP-NF (as buffer) …………11.2mg
10% w/v Solution of Sodium Hydroxide
USP-NF (pH adjustment) ………………….……… q.s.
10% v/v Solution of Hydrochloric Acid
USP-NF (pH adjustment) ………………….……… q.s.
Excipients…………………………………………………q.s.


2) Anidulafungin for Injection 50mg
A) Each vial contains:
Anidulafungin…………….……………………….50mg
Tartaric Acid USP-NF (as buffer) ………….5.6mg
10% w/v Solution of Sodium Hydroxide
USP-NF (pH adjustment) ………………….……… q.s.
10% v/v Solution of Hydrochloric Acid
USP-NF (pH adjustment) ………………….……… q.s.
Excipients………………………………………………… q.s.

THERAPEUTIC INDICATIONS:

Anidulafungin is an antifungal medicine that is used to treat candida (yeast) infections in the blood or the stomach in adults and children at least 1 month old. Anidulafungin is also used to treat candida infections of the esophagus only in adults.

DIRECTION OF USE:

Each vial when reconstituted with 5ml/10ml of Sterile Water for Injection IP. Contains 10mg/ml Anidulafungin as an active ingredient.
For Intravenous Infusion only.

CAUTION AND SCHEDULE:

CAUTION: The Injection should not be used if it contains visible particulate matter after reconstitution.
Anidulafungin Injection is administration as an injection by a healthcare professional, kindly do not self-administer.
Do not skip any doses & finish the full course of treatment even if you feel better.
SCHEDULE: SCHEDULE 'H' PRESCRIPTION DRUG: WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

STORAGE: Store between 2°C to 8°C. Do not Freeze.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by Physician.

Anidulafungin for Injection 100mg Technical Specification:

Product Name:Anidulafungin for Injection 100mg
Brand Name:Generics
Strength:100mg, 50mg
Dosage Form:Lyophilized Powder Injection (Sterile) *Preservative Free
Packing:1 Vial + WFI in Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Anti-fungal
Indication: Anidulafungin is an antifungal medicine that is used to treat candida (yeast) infections in the blood. Anidulafungin is also used to treat candida infections.
Storage:Store between 2°C to 8°C. Do not Freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Anidulafungin for Injection 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Anidulafungin for Injection 100mg
    a)Each vial contains:
    Anidulafungin…………….………………………100mg
    Tartaric Acid USP-NF (as buffer) …………11.2mg
    10% w/v Solution of Sodium Hydroxide
    USP-NF (pH adjustment) ………………….……… q.s.
    10% v/v Solution of Hydrochloric Acid
    USP-NF (pH adjustment) ………………….……… q.s.
    Excipients…………………………………………………q.s

THERAPEUTIC INDICATION:

Anidulafungin is an antifungal medicine that is used to treat candida (yeast) infections in the blood or the stomach in adults and children at least 1 month old. Anidulafungin is also used to treat candida infections of the esophagus only in adults.

DIRECTION OF USE:

Each vial when reconstituted with 10ml of Sterile Water for Injection IP. Contains 10mg/ml Anidulafungin as an active ingredient.
For Intravenous Infusion only.

CAUTION AND SCHEDULE:

CAUTION: The Injection should not be used if it contains visible particulate matter after reconstitution.Anidulafungin Injection is administration as an injection by a healthcare professional, kindly do not self-administer.
Do not skip any doses & finish the full course of treatment even if you feel better.
SCHEDULE: SCHEDULE ‘H’ PRESCRIPTION DRUG: WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store between 2°C to 8°C. Do not Freeze.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals stands out as a preferred choice for Anidulafungin for Injection for several compelling reasons. Foremost among these is their unwavering commitment to quality assurance. When it comes to medications like Anidulafungin, the assurance of quality is paramount. Taj Pharmaceuticals ensures that each batch of Anidulafungin meets rigorous standards for efficacy, safety, and purity, providing healthcare professionals and patients alike with confidence in the product’s effectiveness. With years of experience in the pharmaceutical industry, Taj Pharmaceuticals has cultivated a wealth of expertise in manufacturing and delivering effective medications. Their reputation for consistently producing high-quality pharmaceuticals instills trust among healthcare providers. This experience is not only reassuring but also crucial in ensuring that Anidulafungin reaches those who need it promptly and efficiently.

Consistent availability of medications is essential, especially when it comes to treating fungal infections. Taj Pharmaceuticals understands the importance of a reliable supply chain, ensuring that Anidulafungin for Injection remains readily available to healthcare institutions and patients when needed most. This reliability in the supply chain is a testament to their commitment to supporting the effective treatment of fungal infections. At the core of Taj Pharmaceuticals’ mission is a patient-centered approach. They place a strong emphasis on patient well-being and safety. This commitment aligns seamlessly with the goal of improving patients’ health and ensuring their safety during anti-fungal treatment. Healthcare providers and patients can rest assured that their well-being is prioritized when choosing Taj Pharmaceuticals.

In the realm of affordability, Taj Pharmaceuticals shines as well. Access to essential medications like Anidulafungin should not be hindered by prohibitive costs. Taj Pharmaceuticals may offer competitive pricing options, making the medication more accessible to healthcare institutions and patients alike. This affordability fosters a greater sense of inclusivity in providing effective anti-fungal treatment. Compliance with stringent regulatory standards is non-negotiable in the pharmaceutical industry, and Taj Pharmaceuticals embraces this obligation wholeheartedly. Their dedication to adhering to these standards provides peace of mind to healthcare providers and patients, reinforcing the safety and efficacy of their products. Additionally, Taj Pharmaceuticals places a premium on support and information dissemination. They provide valuable educational resources and support to healthcare providers and patients, enhancing the overall treatment experience. With comprehensive information about Anidulafungin for Injection, its uses, and proper administration, Taj Pharmaceuticals contributes to better treatment outcomes and ensures that healthcare providers and patients are well-informed.

Lastly, Taj Pharmaceuticals’ global presence and distribution network facilitate the availability of Anidulafungin for Injection in various regions, ensuring that it reaches healthcare providers and patients worldwide. This global reach underscores their commitment to making effective anti-fungal treatment accessible on a global scale. In sum, Taj Pharmaceuticals’ dedication to quality, reliability, affordability, compliance, and support makes it a compelling choice for healthcare providers seeking a trusted supplier for Anidulafungin for Injection and other pharmaceutical needs.

What is Anidulafungin for Injection and its uses:

Anidulafungin for Injection is a medication used to treat fungal infections. It belongs to a class of antifungal drugs known as echinocandins and is administered intravenously (through an IV). Here’s an overview of Anidulafungin for Injection and its uses:

Anidulafungin for Injection:

Anidulafungin is the active ingredient in this medication. It works by inhibiting the synthesis of a key component of the fungal cell wall called beta-(1,3)-D-glucan. By disrupting the fungal cell wall, Anidulafungin weakens and ultimately kills the fungal cells, making it an effective antifungal agent.

Uses:

  • Invasive Candidiasis: Anidulafungin for Injection is commonly used to treat invasive candidiasis, a serious fungal infection caused by Candida species. Invasive candidiasis can affect various organs in the body and is often seen in hospitalized patients, especially those with weakened immune systems or those who have undergone surgery.
  • Esophageal Candidiasis: It is also used for the treatment of esophageal candidiasis, a fungal infection of the esophagus, which can cause symptoms such as difficulty swallowing and pain in the chest or throat.
  • Candidemia: Candidemia is a bloodstream infection caused by Candida species. Anidulafungin may be used to treat candidemia in both adults and pediatric patients.
  • Prophylaxis: In certain situations, Anidulafungin may be used prophylactically, which means it is administered to patients at high risk of developing invasive fungal infections. This preventive approach is often employed in patients undergoing bone marrow transplants or hematopoietic stem cell transplants.
  • Other Fungal Infections: While Anidulafungin is primarily indicated for Candida infections, it may also have some efficacy against other fungal pathogens. Healthcare providers may consider its use in select cases where it is deemed appropriate.

It’s important to note that the use of anti-fungal medications, including Anidulafungin for Injection, should be determined by a healthcare provider based on the specific fungal infection, its severity, and the patient’s medical history. Treatment with Anidulafungin typically requires careful monitoring, especially in hospitalized patients, to ensure its effectiveness and safety.

How Does Anidulafungin for Injection Work?

Anidulafungin for Injection is an antifungal medication that works by targeting a crucial component of fungal cell walls, specifically the beta-(1,3)-D-glucan. Here’s how Anidulafungin works:

  • Inhibition of Beta-(1,3)-D-Glucan Synthesis: Fungal cells, including those of Candida species, have cell walls that are essential for their structure and integrity. One critical component of these cell walls is beta-(1,3)-D-glucan. This polysaccharide plays a vital role in maintaining the strength and stability of the fungal cell wall.
  • Disruption of Fungal Cell Wall: Anidulafungin belongs to a class of antifungal drugs called echinocandins. It specifically inhibits an enzyme called 1,3-beta-D-glucan synthase, which is responsible for synthesizing beta-(1,3)-D-glucan in the fungal cell wall.
  • Weakening of Fungal Cells: By inhibiting beta-(1,3)-D-glucan synthesis, Anidulafungin disrupts the formation and maintenance of the fungal cell wall. This disruption weakens the fungal cell structure, making it more susceptible to damage and eventual death.
  • Fungal Cell Death: As the fungal cell wall becomes compromised and weakened, it is unable to protect the fungal cell from environmental stressors and osmotic pressure changes. This ultimately leads to the lysis (rupture) of the fungal cell and its death.
  • Selective Action: Anidulafungin has a selective action against fungal cells while sparing human cells. This selectivity is due to differences in cell wall composition between fungi and human cells. Human cells do not have beta-(1,3)-D-glucan in their cell walls, making them less susceptible to the effects of Anidulafungin.

By targeting the fungal cell wall, Anidulafungin effectively weakens and destroys the fungal cells, making it a valuable tool in the treatment of fungal infections, especially those caused by Candida species. It is important to note that the specificity of Anidulafungin for fungal cell walls contributes to its safety profile, as it minimizes the impact on human cells. However, like all medications, Anidulafungin should be used under the guidance and prescription of a healthcare provider.

Benefits of Anidulafungin for Injection:

  • Highly Effective Antifungal Treatment: Anidulafungin is a potent antifungal medication, particularly effective against invasive fungal infections caused by Candida species. Its effectiveness makes it a valuable tool for healthcare providers in treating serious fungal infections.
  • Broad-Spectrum Activity: While primarily used for Candida infections, Anidulafungin may also demonstrate efficacy against a range of other fungal pathogens. This broad-spectrum activity expands its utility, allowing for the treatment of various fungal infections.
  • Minimal Drug Interactions: Anidulafungin has a relatively low likelihood of interacting with other medications, simplifying treatment regimens for patients who may require multiple medications concurrently.
  • Convenient Intravenous Administration: Being administered intravenously, Anidulafungin is suitable for patients who cannot take oral medications or when rapid and reliable drug delivery is essential.

These benefits highlight Anidulafungin’s effectiveness and versatility as an antifungal medication, particularly in the treatment of serious fungal infections where timely and targeted intervention is crucial. It plays a vital role in improving patient outcomes and managing fungal infections effectively.

Side Effects of Anidulafungin for Injection:

  • Common Side Effects: Common side effects of Anidulafungin may include diarrhea, nausea, vomiting, headache, and changes in liver function test results. These side effects are generally mild and transient.
  • Infusion-Related Reactions: Infusion-related reactions, such as flushing, rash, and itching, may occur during or after the administration of Anidulafungin. Healthcare providers often monitor patients during the infusion to manage and address any potential reactions promptly.
  • Hepatic Effects: Anidulafungin can affect liver function, leading to elevated liver enzymes. Regular monitoring of liver function is typically conducted during treatment to detect any changes.
  • Potential Allergic Reactions: While rare, some individuals may experience allergic reactions to Anidulafungin, which can manifest as skin rash, itching, swelling, and more severe allergic responses. Immediate medical attention is required in case of severe allergic reactions.
  • Electrolyte Imbalances: In some cases, Anidulafungin may lead to changes in electrolyte levels, such as potassium and magnesium. These imbalances should be monitored and corrected as needed.
  • Interactions with Other Medications: Although Anidulafungin has a lower likelihood of drug interactions compared to some other antifungal agents, it is essential for healthcare providers to consider potential interactions when prescribing it alongside other medications.
  • Rare Severe Adverse Events: While uncommon, severe adverse events such as liver failure and anaphylaxis have been reported in rare cases. Prompt medical attention is crucial if these severe events occur.

It’s important to note that the benefits of Anidulafungin for treating invasive fungal infections often outweigh the potential side effects, especially in patients with life-threatening fungal infections. Healthcare providers carefully assess the patient’s medical condition and weigh the risks and benefits when prescribing Anidulafungin. Patients should communicate any concerns or unusual symptoms to their healthcare team during treatment.

Frequently Asked Questions About Anidulafungin for Injection:

Certainly, here are some frequently asked questions (FAQs) about Anidulafungin for Injection:

  1. What is Anidulafungin for Injection used for?

Anidulafungin for Injection is used to treat fungal infections, particularly invasive fungal infections caused by Candida species. It is also used for esophageal candidiasis and may have efficacy against other fungal pathogens.

  1. How is Anidulafungin for Injection administered?

Anidulafungin is administered intravenously (IV) by a healthcare provider. The dosage and duration of treatment depend on the specific fungal infection being treated.

  1. Can Anidulafungin be used for all types of fungal infections?

Anidulafungin is primarily indicated for Candida infections, but it may have some efficacy against other fungal pathogens. Healthcare providers determine its use based on the type and severity of the fungal infection.

  1. What are the common side effects of Anidulafungin for Injection?

Common side effects may include diarrhea, nausea, vomiting, headache, and changes in liver function test results. Infusion related reactions such as flushing and rash may also occur.

  1. Is Anidulafungin safe for all patients, including those with liver or kidney problems?

Healthcare providers consider the patient’s medical history and condition when prescribing Anidulafungin. Special precautions may be necessary for patients with liver or kidney issues.

  1. How long does the treatment with Anidulafungin last?

The duration of treatment with Anidulafungin depends on the specific fungal infection and the patient’s response to treatment. Healthcare providers determine the treatment duration.

  1. Are there any specific drug interactions with Anidulafungin?

Anidulafungin has a lower likelihood of drug interactions compared to some other antifungal agents. However, healthcare providers consider potential interactions when prescribing it alongside other medications.

  1. Can Anidulafungin be used during pregnancy or breastfeeding?

The use of Anidulafungin during pregnancy or breastfeeding should be carefully considered by healthcare providers. They weigh the potential benefits against any potential risks to the mother and baby.

  1. What should I do if I experience an allergic reaction to Anidulafungin?

If you experience symptoms of an allergic reaction, such as rash, itching, swelling, or difficulty breathing, seek immediate medical attention. Allergic reactions to Anidulafungin are rare but can be serious.

  1. Can I discontinue treatment with Anidulafungin if my symptoms improve?

It’s essential to complete the full course of treatment as prescribed by your healthcare provider, even if your symptoms improve before the treatment is finished. Stopping treatment prematurely can lead to a recurrence of the fungal infection.

Patients should discuss any questions or concerns about Anidulafungin for Injection with their healthcare providers to ensure safe and effective treatment.

As Anidulafungin for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Anidulafungin for Injection product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Anidulafungin for Injection Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Anidulafungin for Injection, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274