Ayunova Pharmaceutical LLP

Oseltamivir Phosphate 30 mg Tablets BP

Oseltamivir 30 mg Tablets BP is a neuraminidase inhibitor antiviral used for the treatment and prevention of influenza A and B infections.

• Oseltamivir – inhibits viral neuraminidase enzyme, preventing the release of new influenza virus particles and limiting viral spread.

• Effective in reducing the severity and duration of flu symptoms when administered early in the course of infection.

• Commonly used in both adults and children for treatment and prophylaxis during influenza outbreaks.

Each tablet contains:

• Oseltamivir Phosphate BP/USP – 30 mg

• Excipients: Suitable tablet base, binders, fillers, and disintegrants

Oseltamivir 30 mg Tablets are indicated for:

1. Treatment of Influenza A and B

   • Reduces duration and severity of flu symptoms

2. Post-exposure prophylaxis

   • Prevention of influenza in individuals exposed to infected patients

3. High-risk populations

   • Elderly, immunocompromised, or patients with chronic illnesses

4. Control of influenza outbreaks in community and hospital settings

5. Adjunctive therapy to reduce influenza-related complications

• Adults and children: As per body weight and medical guidelines

• Can be taken with or without food

• Complete the full prescribed course for maximum efficacy

• Dose adjustment may be required in renal impairment

• Blister packs: 10 / 14 / 20 / 28 tablets per strip

• Boxes with product information leaflet

• Store below 25°C

• Protect from light and moisture

• Keep out of reach of children

Acyclovir for Injection BP

Acyclovir for Injection BP is a synthetic antiviral agent used for the treatment of serious viral infections caused by herpesviruses, including Herpes Simplex Virus (HSV) and Varicella-Zoster Virus (VZV).

It works by inhibiting viral DNA polymerase, which prevents viral DNA synthesis, thereby stopping viral replication. Acyclovir is highly effective in treating severe systemic viral infections, herpes encephalitis, neonatal HSV infections, and shingles, especially in immunocompromised patients.

Each vial contains:

• Acyclovir BP – 250 mg / 500 mg / 1 g

• Excipients: q.s. for injection (lyophilized powder)

After reconstitution with sterile water or suitable diluent, it is ready for intravenous (IV) infusion.

Acyclovir for Injection is indicated for:

1. Severe Herpes Simplex Virus (HSV) infections including:

   • Herpes encephalitis

   • Neonatal HSV infections

   • Disseminated HSV infections in immunocompromised patients

2. Varicella-Zoster Virus (VZV) infections including:

   • Severe shingles (herpes zoster)

   • Disseminated VZV in immunocompromised patients

3. Prophylaxis of HSV infections in immunocompromised patients

4. Treatment of severe or life-threatening viral infections where oral therapy is not feasible

• Adults: 5–10 mg/kg IV every 8 hours depending on infection severity

• Children: 10 mg/kg IV every 8 hours (pediatric dosing as per guidelines)

• Route: IV infusion over 1 hour

• Monitoring: Renal function should be monitored during therapy

• Should be administered under medical supervision

• Vials: 250 mg / 500 mg / 1 g per vial

• Lyophilized powder, single-use vials

• Bulk and institutional packaging available

• Store below 25°C

• Protect from light and moisture

• Keep out of reach of children

Remdesivir for Injection BP

Remdesivir for Injection BP is a broad-spectrum antiviral agent used for the treatment of COVID-19 in hospitalized patients. It is a prodrug of an adenosine nucleotide analog that inhibits viral RNA-dependent RNA polymerase, preventing viral replication.

This sterile injectable formulation is intended for intravenous (IV) administration under hospital supervision. Remdesivir is recommended for patients with moderate to severe COVID-19, particularly those requiring supplemental oxygen.

Each vial contains:

• Remdesivir BP – 100 mg

• Excipients: q.s. sterile lyophilized powder for injection

After reconstitution, it is ready for intravenous infusion.

• Treatment of hospitalized COVID-19 patients with moderate to severe disease

• Patients requiring supplemental oxygen but not yet on mechanical ventilation

• Treatment of adult and pediatric patients (≥12 years and ≥40 kg) with confirmed SARS-CoV-2 infection

• Adjunct therapy in combination with standard of care treatments for COVID-19

• Supportive treatment in high-risk patients to reduce disease progression

• Route: Intravenous (IV) infusion

• Adult Dose: 200 mg IV on Day 1, followed by 100 mg IV once daily for 4 more days (total 5 days)

• Pediatric Dose: Weight-based dosing as per guidelines

• Monitoring: Liver function, renal function, clinical status, and infusion-related reactions

⚠ Administer only under specialist supervision

• Available strength: 100 mg vial

• Lyophilized powder for injection

• Hospital and bulk packaging available

• Store 2–8°C (Refrigerated)

• Protect from light

• Do not freeze

• Keep out of reach of children

Ganciclovir for Injection BP

Ganciclovir for Injection BP is a potent antiviral agent used for the treatment and prevention of cytomegalovirus (CMV) infections in immunocompromised patients, including organ transplant recipients and HIV-infected patients. It is a synthetic nucleoside analog that inhibits viral DNA polymerase, thereby preventing viral replication.

This sterile injectable formulation is intended for intravenous administration under specialist supervision, ensuring rapid therapeutic action against CMV infections.

Each vial contains:

• Ganciclovir BP – 500 mg / 250 mg

• Excipients: q.s. sterile water for injection (lyophilized powder)

After reconstitution, it is ready for intravenous infusion.

• Treatment of CMV retinitis in immunocompromised patients (e.g., HIV/AIDS)

• Prevention of CMV disease in organ transplant recipients (kidney, liver, heart)

• Treatment of severe systemic CMV infections in immunocompromised patients

• Adjunct therapy in CMV prophylaxis for high-risk patients

• Management of CMV pneumonia, gastrointestinal, or hepatic involvement

• Route: Intravenous (IV) infusion

• Adult Dose: Typically 5 mg/kg IV every 12 hours for 14–21 days for induction therapy

• Maintenance Dose: 5 mg/kg IV once daily, adjusted for renal function

• Pediatric Dose: Weight-based, adjusted per protocol

• Monitoring: Renal function, complete blood count, liver function, and electrolyte levels

⚠ Administer only under specialist supervision

• Available strengths: 250 mg, 500 mg vials

• Lyophilized powder for injection

• Hospital and bulk packaging available

• Store 2–8°C (Refrigerated)

• Protect from light and moisture

• Do not freeze

• Keep out of reach of children

Interferon Alfa-2b for Injection BP

Interferon Alfa-2b for Injection BP is a recombinant human cytokine used for antiviral, immunomodulatory, and antiproliferative therapy. It is a glycoprotein produced via recombinant DNA technology that modulates the immune response and inhibits viral replication.

This sterile injectable formulation is intended for subcutaneous or intramuscular administration under specialist supervision and is widely used in infectious disease, oncology, and hematology treatment centers.

Each vial contains:

• Interferon Alfa-2b BP – 3 million IU / 6 million IU / 9 million IU

• Excipients: q.s. sterile water for injection or suitable buffer (lyophilized powder)

After reconstitution, it is ready for subcutaneous (SC) or intramuscular (IM) injection.

• Chronic Hepatitis B and C – to inhibit viral replication and improve liver function

• Condyloma Acuminata (Genital Warts) – in immunocompromised patients

• Certain hematologic malignancies – e.g., hairy cell leukemia

• Kaposi’s sarcoma – particularly in HIV/AIDS patients

• Multiple sclerosis (off-label under supervision)

• Adjunct therapy in combination with other antivirals or chemotherapeutic agents

• Route: Subcutaneous (SC) or Intramuscular (IM) injection

• Adult Dose: Typically 3–9 million IU 3 times per week, adjusted according to clinical response and condition

• Pediatric Dose: Weight-based, adjusted per protocol

• Monitoring: Complete blood count, liver and kidney function, viral load, and clinical response

⚠ Administer only under specialist supervision

• Available strengths: 3 million IU, 6 million IU, 9 million IU vials

• Lyophilized powder for injection

• Hospital and bulk packaging available

• Store 2–8°C (Refrigerated)

• Protect from light and moisture

• Do not freeze

• Keep out of reach of children

Sofosbuvir + Velpatasvir Tablets BP – Fixed Dose Combination

(Common strength: Sofosbuvir 400 mg + Velpatasvir 100 mg)

Sofosbuvir + Velpatasvir Tablets BP is a pan-genotypic direct-acting antiviral (DAA) combination used for the treatment of chronic Hepatitis C virus (HCV) infection across all major genotypes (1–6).

• Sofosbuvir is a nucleotide analogue NS5B polymerase inhibitor that prevents viral RNA replication.

• Velpatasvir is an NS5A inhibitor that blocks viral replication and assembly.

This fixed-dose combination offers high sustained virologic response (SVR) rates, short treatment duration, and excellent tolerability.

Each film-coated tablet contains:

• Sofosbuvir BP – 400 mg

• Velpatasvir BP – 100 mg

• Excipients: q.s.

• Chronic Hepatitis C infection (Genotypes 1–6) in adults

• Treatment-naïve and treatment-experienced HCV patients

• Compensated liver cirrhosis (with or without cirrhosis)

• HCV-related liver disease management

• HIV-HCV co-infected patients (as prescribed)

• Route: Oral

• Usual Dose: One tablet once daily

• Administration: With or without food

• Treatment Duration: Usually 12 weeks (as prescribed)

⚠ Use under medical supervision only
⚠ Not recommended in severe hepatic impairment without specialist advice

• Alu-Alu blister packs

• HDPE bottles

• Institutional and export packaging available

• Store below 30°C

• Protect from light and moisture

• Keep out of reach of children

Sofosbuvir + Ledipasvir Tablets BP – Fixed Dose Combination

(Common strength: Sofosbuvir 400 mg + Ledipasvir 90 mg)

Sofosbuvir + Ledipasvir Tablets BP is a direct-acting antiviral (DAA) fixed-dose combination indicated for the treatment of chronic Hepatitis C virus (HCV) infection, particularly Genotypes 1, 4, 5, and 6.

• Sofosbuvir is a nucleotide analogue NS5B polymerase inhibitor that inhibits viral RNA replication.

• Ledipasvir is an NS5A inhibitor that interferes with viral replication and virion assembly.

This combination provides high cure rates (SVR), once-daily dosing, and good patient compliance.

Each film-coated tablet contains:

• Sofosbuvir BP – 400 mg

• Ledipasvir BP – 90 mg

• Excipients: q.s.

• Chronic Hepatitis C infection caused by HCV Genotypes 1, 4, 5, and 6

• Treatment-naïve and treatment-experienced patients

• HCV patients with compensated cirrhosis

• Liver disease associated with chronic HCV infection

• HIV–HCV co-infection (as prescribed)

• Route: Oral

• Usual Dose: One tablet once daily

• Administration: With or without food

• Typical Treatment Duration: 12 weeks (may vary based on genotype and cirrhosis status)

⚠ To be used under medical supervision only
⚠ Dose adjustments may be required in special populations

• Alu-Alu blister packs

• HDPE bottles

• Export and institutional packing available

• Store below 30°C

• Protect from light and moisture

• Keep out of reach of children

ACIVIR Infusion contains Aciclovir, an antiviral agent effective against herpes virus infections. It inhibits viral DNA synthesis, thereby preventing viral replication. This formulation is intended for intravenous administration and is commonly used in the treatment of severe or systemic viral infections in hospital settings.

Each vial contains:

• Aciclovir IP – 500 mg

• Sterile excipients / Diluent – q.s.

• Dosage Form: Intravenous infusion

ACIVIR Infusion is indicated for the treatment of:

• Severe herpes simplex virus (HSV) infections

• Varicella-zoster virus (VZV) infections

• Herpes encephalitis

• Severe viral infections in immunocompromised patients

• Administered by intravenous infusion only

• Dosage and duration determined by a registered medical practitioner

• Renal function monitoring recommended during therapy

• Effective antiviral against HSV and VZV

• Suitable for severe and systemic infections

• IP-grade formulation

• Used in hospital and critical care settings

• Store below 25°C

• Protect from light

• Do not freeze

• Keep out of reach of children

• Strength: 500 mg

• Pack Type: Vial / infusion bottle (as applicable)

• Pack Size: 1 unit

METHORA Tablets contain Methotrexate 10 mg, an antimetabolite and immunosuppressant medicine widely used in the management of autoimmune diseases and certain cancers. Methotrexate works by inhibiting dihydrofolate reductase, which suppresses abnormal cell growth and excessive immune activity. Due to its potent action, METHORA Tablets should be taken strictly under medical supervision.

• Active Ingredient:
  Methotrexate IP – 10 mg per tablet

• Excipients:
  q.s.

• Dosage Form:
  Tablet

• Pharmacopoeial Standard:
  IP

METHORA Methotrexate Tablets are indicated for:

• Rheumatoid arthritis and other autoimmune disorders

• Moderate to severe psoriasis

• Certain malignancies such as leukemia and lymphomas

• Other conditions as prescribed by a physician

(Prescription medicine – use only under medical supervision)

• Administered orally as prescribed by the physician

• Generally given once weekly for non-oncological indications

• Tablets should be swallowed whole with water

• Regular monitoring of blood counts, liver, and renal function is essential

• Store below 25°C

• Protect from moisture and light

• Keep out of reach of children

JAKURA Tablets contain Tofacitinib 10 mg, an oral Janus kinase (JAK) inhibitor used in the treatment of autoimmune and inflammatory disorders. Tofacitinib works by blocking JAK enzymes involved in immune system signaling, thereby reducing inflammation, pain, and disease progression. This medication is prescribed for patients who have not responded adequately to conventional therapies and should be used strictly under medical supervision.

• Active Ingredient:
  Tofacitinib – 10 mg per tablet

• Excipients:
  q.s.

• Dosage Form:
  Film-coated tablets

• Pharmacopoeial Standard:
  IP

Tofacitinib Tablets IP 10 mg are indicated for:

• Moderate to severe rheumatoid arthritis

• Psoriatic arthritis

• Ulcerative colitis

• Other autoimmune or inflammatory conditions as prescribed by a physician

(Prescription medicine – use only under medical supervision)

• Dosage as directed by the treating physician

• Taken orally, with or without food

• Tablets should be swallowed whole with water

• Regular monitoring of blood counts, liver function, and lipid levels is recommended

• Store below 30°C

• Protect from moisture and direct sunlight

• Keep out of reach of children

• For prescription use only

• Increased risk of serious infections; monitor patients closely

• Not recommended during pregnancy or breastfeeding unless prescribed

• Use with caution in patients with hepatic, renal, or cardiovascular disorders

• Strip or bottle packing (as available)

• Suitable for hospital, pharmacy, and distributor supply

• Manufactured in compliance with IP and GMP guidelines

• Tested for safety, purity, and efficacy

• India