Nicardipine Hydrochloride Injection USP 25mg/10ml (2.5mg/ml) Technical Specification: Product Name: Nicardipine Hydrochloride Injection USP Brand Name: (GENERICS) Strength: 10mg/10ml (1mg/ml), 25mg/10ml (2.5mg/ml) Dosage Form: Liquid Injection (Sterile) Packing: 10ml Ampoules, Vial (single-dose) Route of Administration: For Intravenous Infusion Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability […]
Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP (5mg+160mg+12.5mg) Technical Specification: Product Name: Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP Brand Name: Generic Strength: (5mg+160mg+12.5mg), (10mg+160mg+12.5mg), (10mg+160mg+25mg), (10mg+320mg+25mg) Dosage Form: Tablets (film-coated) Route of Administration: Via Oral Route Packing: 10s, 30s, 100s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, […]
Furosemide Injection USP 20mg/2mL (10mg/ml) Technical Specification: Product Name: Furosemide Injection USP Brand Name: (Frusotaj) Strength: 20mg/2mL (10mg/ml), 40mg/4mL (10mg/ml), 100mg/10mL (10mg/ml) Dosage Form: Liquid Injection (Sterile) *Non-pyrogenic Packing: 2ml Ampoule, 2ml, 4ml 10 mL vial (SINGLE-DOSE) Route of Administration: For IM/slow IV use. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, […]
Nifedipine Retard Tablets 20mg Technical Specification: Product Name: Nifedipine Retard Tablets 20mg Brand Name: Generic Strength: 10mg, 20mg, 30mg, 40mg, 60mg, 90mg Dosage Form: Tablets (film-coated) Route of Administration: Via Oral Route Packing: 10s, 30s, 100s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, […]
Amlodipine Besylate Tablets USP 10mg Technical Specification: Product Name: Amlodipine Tablets 10mg Brand Name: Generic Strength: 2.5mg, 5mg, 10mg Dosage Form: Tablets (uncoated) Route of Administration: Via Oral Route Packing: 10s, 30s, 100s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier […]
Amlodipine Besylate Tablets USP 5mg Technical Specification: Product Name: Amlodipine Tablets 5mg Brand Name: Generic Strength: 2.5mg, 5mg, 10mg Dosage Form: Tablets (uncoated) Route of Administration: Via Oral Route Packing: 10s, 30s, 100s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier […]
Clopidogrel Tablets IP 75mg Technical Specification: Product Name: Clopidogrel Tablets IP 75mg Brand Name: CLOPITAJ Strength: (75mg), (150mg), (300mg) Dosage Form: Tablets (Film coated) Route of Administration: Via oral Route Packing: 30s, 90s, 100s, 140s Pack Insert/Leaflet: PIL (Patient Information Leaflet) Regulatory Documents: COA, MOA, Stability Studies, GMP Therapeutic use: Antiplatelet, Antihypertensive, Cardiovascular Indication: Clopidogrel […]
Simvastatin Tablets USP 40mg Technical specifications: Product Name: Simvastatin Tablets USP 40mg Brand Name: Generics Strength: 5mg, 10mg, 20mg, 40mg, 80mg Dosage Form: Tablets (Film-coated) Route of Administration: Via oral route Packing: 30s, 90s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD […]
Simvastatin Tablets USP 20mg Technical specifications: Product Name: Simvastatin Tablets USP 20mg Brand Name: Generics Strength: 5mg, 10mg, 20mg, 40mg, 80mg Dosage Form: Tablets (Film-coated) Route of Administration: Via oral route Packing: 30s, 90s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD […]
Amlodipine & Atenolol Tablets (5mg+50mg) Technical Specification: Product Name: Amlodipine & Atenolol Tablets Brand Name: Norvate-AT Strength: (5mg+25mg) , (5mg+50mg) Dosage Form: Tablets (uncoated) Route of Administration: Via Oral Route Packing: 10 Blister strips of 10 Tablets Each Pack Insert/Leaflet: PIL (Patient Information Leaflet) Regulatory Documents: COA, MOA, Stability Studies, GMP Therapeutic use: Antihypertensive Indication: […]