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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, […]
Dosulepin Tablets BP 75mg Technical Specification: Product Name: Dosulepin Tablets BP 75mg Brand Name: DROTHITAJ Strength: 25mg, 50mg, 75mg 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 […]
Fluoxetine Capsules USP 20mg Technical Specification: Product Name: Fluoxetine Capsules USP Brand Name: Generics Strength: 10mg, 20mg, 40mg, 60mg Dosage Form: Capsule (Hard gelatine) 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, […]
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, […]
Metoprolol Succinate Extended-Release Tablet USP 25mg Technical Specification: Product Name: Metoprolol Succinate Extended-Release Tablet USP 200mg Brand Name: Metrol XL Strength: 12.5mg, 25mg, 50mg, 100mg, 200mg Dosage Form: Extended-Release Tablets (film-coated) Route of Administration: Via Oral Route Packing: 10s, 20s, 30s, 50s, 150s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: […]
Metoprolol Succinate Extended-Release Tablet USP 50mg Technical Specification: Product Name: Metoprolol Succinate Extended-Release Tablet USP 50mg Brand Name: Metrol XL Strength: 12.5mg, 25mg, 50mg, 100mg, 200mg Dosage Form: Extended-Release Tablets (film-coated) Route of Administration: Via Oral Route Packing: 10s, 20s, 30s, 50s, 150s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: […]
Metoprolol Succinate Extended-Release Tablet USP 100mg Technical Specification: Product Name: Metoprolol Succinate Extended-Release Tablet USP 100mg Brand Name: Metrol XL Strength: 12.5mg, 25mg, 50mg, 100mg, 200mg Dosage Form: Extended-Release Tablets (film-coated) Route of Administration: Via Oral Route Packing: 10s, 20s, 30s, 50s, 150s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: […]
Metoprolol Succinate Extended-Release Tablet USP 200mg Technical Specification: Product Name: Metoprolol Succinate Extended-Release Tablet USP 200mg Brand Name: Metrol XL Strength: 12.5mg, 25mg, 50mg, 100mg, 200mg Dosage Form: Extended-Release Tablets (film-coated) Route of Administration: Via Oral Route Packing: 10s, 20s, 30s, 50s, 150s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: […]
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, […]
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 […]
Cefepime for Injection USP 1gm Technical Specification: Product Name: Cefepime for Injection USP 1gm Brand Name: Maximtaj Strength: 1gm, 2gm, 500mg, 250mg Dosage Form: Dry Powder Injection (Sterile) Packing: Vial + WFI in Tray 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, […]
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 […]
Budesonide Nebuliser Suspension BP 0.5mg/2ml Technical Specification: Product Name: Budesonide Nebuliser Suspension BP Brand Name: Asthacort Strength: 0.5mg/2ml, 1mg/2ml 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, […]
Lornoxicam for Injection 8mg Technical Specification: Product Name: Lornoxicam for Injection Brand Name: Xloritom Inj Strength: 8mg Dosage Form: Lyophilized Dry Powder Injection (Sterile) *Preservative Free Packing: 1 Vial + 1 Ampule + WFI Tray Route of Administration: For IV/IM use only Pack Insert/Leaflet: PIL (Patient Information Leaflet) Regulatory Documents: COA, MOA, Product Permission, Stability […]
Azithromycin Tablets USP 250mg Technical Specification: Product Name: Azithromycin Tablets USP 250mg Brand Name: Zithromin Strength: 250mg, 500mg, 600mg Dosage Form: Tablets (Film-coated) Route of Administration: Via Oral Route Packing: 10s, 20s, 30s, 50s, 100s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD […]
Azithromycin Tablets USP 500mg Technical Specification: Product Name: Azithromycin Tablets USP 500mg Brand Name: Zithromin Strength: 250mg, 500mg, 600mg Dosage Form: Tablets (Film-coated) Route of Administration: Via Oral Route Packing: 10s, 20s, 30s, 50s, 100s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD […]
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: […]
Griseofulvin Tablets BP 250mg Technical Specification: Product Name: Griseofulvin Tablets BP 250mg (Griseofulvin of Fine Particle) Brand Name: Generic Strength: 125mg, 250mg, 375mg, 500mg 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, […]
Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg) Technical Specification: Product Name: Montelukast Sodium and Levocetirizine Hydrochloride Tablets (10mg+5mg) Brand Name: Xeglyart Strength: (10mg+5mg), (4mg+2.5mg) Dosage Form: Tablet (Film-coated, Uncoated) Route of Administration: Via oral Route Packing: 10s, 30s, 100s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics). Regulatory Documents: COA, MOA, COPP, FSC, […]
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, […]
Rifampicin Capsules BP 150mg Technical Specification: Product Name: Rifampicin Capsules BP 150mg Brand Name: Generic Strength: 150mg, 300mg, 450mg, 600mg Dosage Form: Capsules (Hard-gelatin) 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 […]
Rifampicin Capsules BP 300mg Technical Specification: Product Name: Rifampicin Capsules BP 300mg Brand Name: Generic Strength: 150mg, 300mg, 450mg, 600mg Dosage Form: Capsules (Hard-gelatin) 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 […]
Amlodipine & Atenolol Tablets 5mg+50mg Technical Specification: Product Name: Amlodipine & Atenolol Tablets Brand Name: Norvate-AT Strength: 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: Amlodipine + […]
Primaquine Phosphate Tablets USP 7.5mg Technical Specification: Product Name: Primaquine Phosphate Tablets USP 7.5mg Brand Name: Generic Strength: 7.5mg, 15mg 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 […]
