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Oxaliplatin for Injection USP 50mg (Voxatin) Technical Specification: Product Name: Oxaliplatin for Injection USP 50mg Brand Name: Voxatin Strength: 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, […]
Oxaliplatin for Injection USP 100mg (Voxatin) Technical Specification: Product Name: Oxaliplatin for Injection USP 100mg Brand Name: Voxatin Strength: 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, […]
Methylprednisolone Sodium Succinate for Injection USP 500mg Technical Specification: Product Name: Methylprednisolone Sodium Succinate for Injection USP Brand Name: M-Prednitaj Strength: 1gm, 500mg, 125mg, 40mg. Dosage Form: Dry Powder for Injection (Sterile) Packing: 1 Vial + WFI Route of Administration: For I.V./I.M. use only Pack Insert/Leaflet: PIL (Patient Information Leaflet) Documents: COA, MOA, Product Permission, […]
Methylprednisolone Sodium Succinate for Injection USP 1gm Technical Specification: Product Name: Methylprednisolone Sodium Succinate for Injection USP Brand Name: M-Prednitaj Strength: 1gm, 500mg, 125mg, 40mg. Dosage Form: Dry Powder for Injection (Sterile) Packing: 1 Vial + WFI Route of Administration: For I.V./I.M. use only Pack Insert/Leaflet: PIL (Patient Information Leaflet) Documents: COA, MOA, Product Permission, […]
Gliclazide Modified Release Tablets BP 60mg Technical Specification: Product Name: Gliclazide Modified Release Tablets BP 60mg Brand Name: Generic Strength: 30mg, 60mg 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, […]
Gliclazide Tablets 60mg Technical Specification: Product Name: Gliclazide Tablets Brand Name: Generics Strength: 30mg, 40mg, 60mg, 80mg 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 […]
Ambroxol Hydrochloride Respiratory Solution 15mg Technical Specification: Product Name: Ambroxol Hydrochloride Respiratory Solution Brand Name: Mucoshield Strength: 15mg/Respule Dosage Form: Nebuliser / Respules for inhalation Only **Preservative Free Route of Administration: Via Inhalation Route Only Packing: 2ml Respules Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability […]
Esomeprazole Gastro-resistant Tablets 40mg Technical Specification: Product Name: Esomeprazole Gastro-resistant Tablets 40mg Brand Name: Generic Strength: 20mg, 40mg Dosage Form: Tablets (Gastro-resistant) Route of Administration: Via Oral Route Packing: 10s, 30s, 100s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier Therapeutic use: […]
Omeprazole Gastro-resistant Capsules BP 20mg Technical Specification: Product Name: Omeprazole Gastro-resistant Capsules BP 20mg Brand Name: Prilosid Strength: 10mg, 20mg, 40mg Dosage Form: Capsules (Hard Gelatin) Route Of Administration: Via oral route Packing: 10s, 20s, 30s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics). Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, […]
Imatinib Mesylate Tablets 100mg (Tyronib) Technical Specification: Product Name: Imatinib Mesylate Tablets 100mg Brand Name: Tyronib Strength: 100mg, 400mg Dosage Form: Tablets Packing: 6s, 10s, 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 […]
Imatinib Mesylate Tablets 400mg (Tyronib) Technical Specification: Product Name: Imatinib Mesylate Tablets 400mg Brand Name: Tyronib Strength: 100mg, 400mg Dosage Form: Tablets Packing: 6s, 10s, 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 […]
Captopril Tablets 25mg Technical Specification: Product Name: Captopril Tablets 25mg Brand Name: CAPOTAJ Strength: 12.5mg, 25mg, 50mg, 100mg Dosage Form: Tablets (uncoated) Route of Administration: Via oral route Packing: 30s, 90s, 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 […]
Captopril Tablets 50mg Technical Specification: Product Name: Captopril Tablets 50mg Brand Name: CAPOTAJ Strength: 12.5mg, 25mg, 50mg, 100mg Dosage Form: Tablets (uncoated) Route of Administration: Via oral route Packing: 30s, 90s, 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 […]
Procarbazine Hydrochloride Capsules USP 50mg Technical Specification: Product Name: Procarbazine Hydrochloride Capsules USP 50mg Brand Name: P-Carbataj Strength: 50mg Dosage Form: Hard-Gelatin Capsules Packing: 10s, 28s, 100s 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 […]
Lisinopril Tablets USP 5mg Technical Specification: Product Name: Lisinopril Tablets USP 5mg Brand Name: Lisotaj Strength: 2.5mg, 5mg, 10mg, 20mg, 30mg, 40mg 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, […]
Lisinopril Tablets USP 10mg Technical Specification: Product Name: Lisinopril Tablets USP 10mg Brand Name: Lisotaj Strength: 2.5mg, 5mg, 10mg, 20mg, 30mg, 40mg 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, […]
Favipiravir Tablets 200mg Technical Specification: Product Name: Favipiravir Tablets 200mg Brand Name: Fabitaj Strength: 200mg, 400mg, 800mg Dosage Form: Film-coated Tablet Packing: 10s, 17s, 34s 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: […]
Favipiravir Tablets 400mg Technical Specification: Product Name: Favipiravir Tablets 400mg Brand Name: Fabitaj Strength: 200mg, 400mg, 800mg Dosage Form: Film-coated Tablet Packing: 10s, 17s, 34s 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: […]
Ibrutinib Capsules 140mg Technical Specification: Product Name: Ibrutinib Capsules 140mg Brand Name: Imbrutaj Strength: 70mg, 140mg Dosage Form: Hard-Gelatin Capsules Packing: 30s, 90s, 120s 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 […]
Hydrocortisone Sodium Succinate Injection USP 100mg Technical Specification: Product Name: Hydrocortisone Sodium Succinate Injection USP 100mg Brand Name: HYDROTAJ Strength: 100mg, 200mg, 250mg, 500mg, 1000mg Dosage Form: Dry Powder for Injection (Sterile) *Preservative Free Packing: 1 Vial + WFI in a Tray Route of Administration: For I.M or Slow I.V use only Pack Insert/Leaflet: PIL […]
Doxycycline and Lactic Acid Bacillus Capsules (100mg+5 billion) Technical Specification: Product Name: Doxycycline and Lactic Acid Bacillus Capsules Brand Name: Doxitaj-SL Strength: (100mg+5 billion) Dosage Form: Capsules (Hard-gelatin) 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-biotic, Anti-bacterial, […]
Famotidine Tablets 10mg Technical Specification: Product Name: Famotidine Tablets 10mg Brand Name: PRILOSID AC Strength: 10mg, 20mg, 40mg 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 […]
Paracetamol Intravenous Infusion BP 0.5% w/v (Parataj I.V.) Technical Specification: Product Name: Paracetamol Intravenous Infusion BP 0.5% w/v or 500mg/100ml Brand Name: Parataj I.V. Strength: (1% w/v or 1000mg/100ml), (0.5% w/v or 500mg/100ml) Dosage Form: I.V. Infusion Bottle (LVP) Packing: 100mL IV Bottle Route of Administration: For I.V. use only Pack Insert/Leaflet: PIL (Patient Information […]
Ciprofloxacin Intravenous Infusion BP 2mg/ml (ciprotaj) Technical Specification: Product Name: Ciprofloxacin Intravenous Infusion BP 2mg/ml Brand Name: ciprotaj Strength: (0.2%w/v or 200mg/100ml or 2mg/ml) Dosage Form: I.V. Infusion Bottle (LVP) Packing: 100mL, 200mL IV Bottle Route of Administration: For I.V. use only Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, […]
