GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Darunavir Ethanolate & Ritonavir Tablet (400mg+50mg)
B. Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg)
C. Darunavir Ethanolate & Ritonavir Tablet (800mg+100mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Darunavir Ethanolate & Ritonavir Tablet (400mg+50mg)
Each film coated tablet contains:
Darunavir Ethanolate Equivalent to Darunavir………400mg
Ritonavir USP………………...50mg
Excipients……………………...q. s
Color: Titanium Dioxide USP

B) Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg)
Each film coated tablet contains:
Darunavir Ethanolate Equivalent to Darunavir………600mg
Ritonavir USP………………...100mg
Excipients……………………...q. s
Color: Yellow Oxide of Iron USP-NF

C) Darunavir Ethanolate & Ritonavir Tablet (800mg+100mg)
Each film coated tablet contains:
Darunavir Ethanolate Equivalent to Darunavir………800mg
Ritonavir USP………………...100mg
Excipients……………………...q. s
Color: Indigo Carmine Lake

THERAPEUTIC INDICATIONS:

Darunavir is an antiviral medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). Darunavir must be given in combination with ritonavir and other antiviral medications and should not be used alone.
Ritonavir is a protease inhibitor used for the treatment of HIV/AIDS. It is seldom employed for its own antiviral activity but instead serves as a booster for other protease inhibitors.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Keep container tightly closed.
Tablet to be swallowed as a whole, not to be chewed or crushed.

KEEP MEDICINE OUT OF REACH OF CHILDREN.
NOT TO EXCEED PRESCRIBED DOSAGE.
WARNING:
Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:
Store at temperature not exceeding 30℃.
Store in cool & dry place.
Protect from Light & moisture.
Dosage:
As directed by the Physician.

Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Technical Specification:

Product Name:Darunavir Ethanolate & Ritonavir Tablets
Brand Name:Generic
Strength:(400mg+50mg), (600mg+100mg), (800mg+100mg)
Dosage Form:Tablets (film-coated)
Route of Administration:Via Oral Route
Packing:30 Tablets in a bottle
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Protease Inhibitors, Antiviral
Indication: Darunavir is an antiviral medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). Darunavir must be given in combination with ritonavir and other antiviral medications and should not be used alone. Ritonavir is a protease inhibitor used for the treatment of HIV/AIDS. It is seldom employed for its own antiviral activity but instead serves as a booster for other protease inhibitors.
Storage:Store at a temperature not exceeding 30℃. Store in a cool & dry place. Protect from Light & moisture.

Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Manufacturers, and Suppliers in India:

Taj Pharmaceuticals is of the prominent Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Manufacturers in India that brings the best quality products. Our company Taj Pharma carries a rich experience in the niche manufacturing of Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg)

Taj Pharmaceuticals is a reputed manufacturer and Darunavir Ethanolate & Ritonavir Tablets Suppliers in India prefer Taj Pharma is best known for the topmost standards and consistent quality of its products.

Taj Pharma is a well-known Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Manufacturer in India that gives the assurance of high- quality and high standards. Strict quality control ensures that every batch of medicine brings a harmonious standard.

Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) manufactured at Taj Pharma follows USP (United States Pharmacopeia); i.e. the product is manufactured to comply with USP quality standards which are considered the Best in the world. Further, Taj Pharma uses Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) grade best active ingredient to manufacture its Injections to comply with international standards of European products.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Darunavir Ethanolate & Ritonavir Tablet (400mg+50mg)
  • Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg)
  • Darunavir Ethanolate & Ritonavir Tablet (800mg+100mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Darunavir Ethanolate & Ritonavir Tablet (400mg+50mg)
    Each film-coated tablet contains:
    Darunavir Ethanolate
    Equivalent to Darunavir………400mg
    Ritonavir USP…………………50mg
    Excipients………………………q. s
    Color: Titanium Dioxide USP
  • Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg)
    Each film-coated tablet contains:
    Darunavir Ethanolate
    Equivalent to Darunavir………600mg
    Ritonavir USP…………………100mg
    Excipients………………………q. s
    Color: Yellow Oxide of Iron USP-NF
  • Darunavir Ethanolate & Ritonavir Tablet (800mg+100mg)
    Each film-coated tablet contains:
    Darunavir Ethanolate
    Equivalent to Darunavir………800mg
    Ritonavir USP…………………100mg
    Excipients………………………q. s
    Color: Indigo Carmine Lake


THERAPEUTIC INDICATIONS:

Darunavir is an antiviral medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). Darunavir must be given in combination with ritonavir and other antiviral medications and should not be used alone.

Ritonavir is a protease inhibitor used for the treatment of HIV/AIDS. It is seldom employed for its own antiviral activity but instead serves as a booster for other protease inhibitors.

CAUTION & WARNING:

CAUTION:
Read the enclosed leaflet before use.
Keep the container tightly closed.
Tablet to be swallowed as a whole, not to be chewed or crushed.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
NOT TO EXCEED THE PRESCRIBED DOSAGE.

WARNING:
Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:
 Store at a temperature not exceeding 30℃.
Store in a cool & dry place.
Protect from Light & moisture.

Dosage:  As directed by the Physician.

As Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) Exporters; We can cater to export business queries from the following geographies. We are exporting our Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) product in 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

Darunavir Ethanolate & Ritonavir Tablets (400mg+50mg) 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)