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Epirubicin Hydrochloride for Injection 100mg Technical Specification: Product Name: Epirubicin Hydrochloride for Injection 100mg Brand Name: Epirubicin Strength: 10mg, 50mg, 100mg Dosage Form: Lyophilized Dry Powder for Injection Packing: SINGLE USE VIAL Route of Administration: For I.V. use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, […]
Verapamil Hydrochloride Tablets IP 40mg Technical Specification: Product Name: Verapamil Hydrochloride Tablets IP Brand Name: Generic Strength: 40mg, 80mg Dosage Form: Tablets (Film coated) Route of Administration: Via Oral Route Packing: 10s, 30s, 100s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet) Documents: COA, MOA, Stability Studies, GMP Therapeutic use: Anti-hypertensive, Cardiovascular System, Antianginal Indication: Verapamil […]
Vincristin Sulfate Injection USP 1mg/ml (2mg/2ml) (Vratucan) Technical Specification: Product Name: Vincristin Sulfate Injection USP (2mg/2ml) Brand Name: Vratucan Strength: 1mg/ml (1mg/1ml, 2mg/2ml) Dosage Form: Liquid Injection Packing: SINGLE-USE VIAL Route of Administration: For I.V. use only Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, […]
Ondansetron Injection USP 8mg/4mL (2mg/ml) Technical Specification: Product Name: Ondansetron Injection USP Brand Name: (GENERICS) Strength: (4mg/2mL), (8mg/4mL), (40mg/20mL) Dosage Form: Liquid Injection (Sterile) *Non-pyrogenic Packing: 2ml, 4ml Ampoule, 2 mL, 20 mL vial Route of Administration: For I.M./I.V. use Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, […]
Ondansetron Injection USP 4mg/2ml Technical Specification: Product Name: Ondansetron Injection USP Brand Name: (GENERICS) Strength: (4 mg/2mL), (8mg/4mL), (40mg/20mL) Dosage Form: Liquid Injection (Sterile) *Non-pyrogenic Packing: 2ml, 4ml Ampoule, 2 mL, 20 mL vial Route of Administration: For I.M./I.V. use Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, […]
Vinorelbine Injection USP 50mg/5ml Technical Specification: Product Name: Vinorelbine Injection USP 50mg/5ml Brand Name: Vinorelbine Strength: 10mg/1ml, 50mg/5ml Dosage Form: Liquid Injection Packing: SINGLE-USE VIAL Route of Administration: For I.V. use only – Must be diluted before Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, […]
Febuxostat Tablet 40mg Technical Specification: Product Name: Febuxostat Tablet Brand Name: Generics Strength: 40mg, 80mg, 120mg Dosage Form: Tablet (Film-coated) Route of Administration: Via oral Route Packing: 30s, 90s, 100s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier Therapeutic use: Antigout Drugs, […]
Prednisolone Tablets BP 10mg Technical Specification: Product Name: Prednisolone Tablets BP 10mg Brand Name: Syntacort Strength: 5mg,10mg, 20mg Dosage Form: Tablets (uncoated) Route of Administration: Via oral route Packing: 10s, 30s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics). Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier Therapeutic use: Corticosteroid […]
Flunarizine Tablet 10mg Technical Specification: Product Name: Flunarizine Tablet Brand Name: Generics Strength: 5mg, 10mg Dosage Form: Tablets (Uncoated) Route of Administration: Via oral Route Packing: 30s, 90s, 100s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier Therapeutic use: Calcium channel Blockers […]
Doxorubicin Hydrochloride for Injection BP 10mg Technical Specification: Product Name: Doxorubicin Hydrochloride for Injection BP 10mg Brand Name: DOXOTAJ Strength: 50mg,10mg Dosage Form: Lyophilised Powder Injection (Sterile) *Preservative-free Packing: Single dose Vial Route of Administration: For I.V. use only (After dilution) Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, […]
Doxorubicin Hydrochloride for Injection BP 50mg Technical Specification: Product Name: Doxorubicin Hydrochloride for Injection BP 50mg Brand Name: DOXOTAJ Strength: 50mg,10mg Dosage Form: Lyophilised Powder Injection (Sterile) *Preservative-free Packing: Single dose Vial Route of Administration: For I.V. use only (After dilution) Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, […]
Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml) Technical Specification: Product Name: Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml) Brand Name: Leucovorin Strength: 10mg/ml (50mg/5ml, 100mg/10ml, 175mg/17.5ml, 250mg/25ml, 300mg/30ml, 500mg/50ml – VIAL) 15mg/ 2ml – Ampoule Dosage Form: Liquid Injection Packing: SINGLE USE VIAL Route of […]
Lenalidomide Capsules 5mg Technical Specification: Product Name: Lenalidomide Capsules 5mg Brand Name: Myelosar Strength: 5mg, 10mg, 15mg, 25mg Dosage Form: Hard-Gelatin Capsules Packing: 10s, 21s, 28s, 30s Route of Administration: For Oral Use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier […]
Paclitaxel Injection USP 6mg/ml (100mg/16.7ml) Technical Specification: Product Name: Paclitaxel Injection USP 6mg/ml (100mg/16.7ml) Brand Name: Paclitaxel Strength: 6mg/ml (30mg/5ml, 100mg/16.7ml, 150mg/25ml, 260mg/43.3ml, 300mg/50ml) Dosage Form: Liquid Injection Packing: MULTI DOSE VIAL Route of Administration: For I.V. Infusion after dilution Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, […]
Etoposide Capsules USP 50mg Technical Specification: Product Name: Etoposide Capsules USP 50mg Brand Name: Etoposide Strength: 50mg, 100mg Dosage Form: Hard-Gelatin Capsules Packing: 4s, 12s, 8s, 20s Route of Administration: For Oral Use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier […]
Etoposide Capsules USP 100mg (Lifepoyz) Technical Specification: Product Name: Etoposide Capsules USP 100mg Brand Name: Etoposide Strength: 50mg, 100mg Dosage Form: Hard-Gelatin Capsules Packing: 4s, 12s, 8s, 20s Route of Administration: For Oral Use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD […]
Mercaptopurine Tablets USP 50mg Technical Specification: Product Name: Mercaptopurine Tablets USP 50mg Brand Name: Mercaptopurine Strength: 10mg, 50mg Dosage Form: uncoated Tablet Packing: 10s, 25s, 30s, 60s, 250s Route of Administration: For Oral Use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD […]
Diclofenac Sodium/Misoprostol Tablets 75mg/200mcg Technical Specification: Product Name: Diclofenac Sodium/Misoprostol Tablets Brand Name: Generic Strength: 50mg/200mcg, 75mg/200mcg 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, GMP, CTD Dossier Therapeutic use: […]
Thioguanine Tablets 40mg Technical Specification: Product Name: Thioguanine Tablets 40mg Brand Name: Thioguanine Strength: 40mg Dosage Form: Tablets Packing: 10s, 25s, 30s Route of Administration: For Oral Use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier Therapeutic use: Anti-Cancer Indication: Tioguanine […]