Daclatasvir and Sofosbuvir Tablets Technical Specification: Product Name:Daclatasvir and Sofosbuvir Tablets 60mg/400mgBrand Name:GenericStrength:60mg+400mgDosage Form:Tablets (film-coated tablet)Route of Administration:Via Oral RoutePacking:10s, 28sPack Insert/Leaflet:PIL (Patient Information Leaflet)Documents:COA, MOA, Stability Studies, GMPTherapeutic use:Hepatitis C Treatment, Antiviral Indication:Daclatasvir is used with sofosbuvir to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. The...
Product Name:Telbivudine TabletBrand Name:GenericsStrength:600mgDosage Form:Tablets (Film-coated)Route of Administration:Via oral routePacking:30s, 90s, 500sPack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD DossierTherapeutic use:Hepatology, hepatitis B virus (HBV)Indication:Telbivudine is used to treat chronic hepatitis B infection. Telbivudine is not a cure for hepatitis B...
Product Name:Sofosbuvir & Velpatasvir TabletsBrand Name:GenericStrength:400mg+100mgDosage Form:Tablets (film coated)Route of Administration:Via Oral RoutePacking:10s, 30s, 100s, 500sPack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD DossierTherapeutic use:HEPATITIS C TREATMENTIndication:Sofosbuvir and velpatasvir combination is used with or without ribavirin to treat chronic hepatitis C...
Product Name:Sofosbuvir TabletsBrand Name:GenericStrength:400mgDosage Form:TabletsRoute of Administration:Via Oral RoutePacking:10s, 30s, 100s, 500sPack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD DossierTherapeutic use:Hepatitis C Treatment, Antiviral Indication:Sofosbuvir is used along with ribavirin (Copegus, Rebetol, Ribasphere, others) and sometimes another medication (peginterferon alfa [Pegasys]) to...
Product Name:Ondansetron Injection IPBrand Name:GenericStrength:4mg/2ml, 8mg/4ml, 40mg/20mlDosage Form:Liquid Injection (Sterile)Packing:2ml, 4ml AmpouleRoute of Administration:For I.M./I.V. usePack Insert/Leaflet:PIL (Patient Information Leaflet)Documents:COA, MOA, Product Permission, Stability Studies, GMPTherapeutic use:Nausea & Vomiting, Anti-emetic, GastroenterologyIndication:Ondansetron injection is used to prevent nausea and vomiting caused by cancer medicines (chemotherapy or radiation), including high-dose cisplatin. This...
Product Name:Ondansetron Injection IPBrand Name:GenericStrength:4mg/2ml, 8mg/4ml, 40mg/20mlDosage Form:Liquid Injection (Sterile)Packing:2ml, 4ml AmpouleRoute of Administration:For I.M./I.V. usePack Insert/Leaflet:PIL (Patient Information Leaflet)Documents:COA, MOA, Product Permission, Stability Studies, GMPTherapeutic use:Nausea & Vomiting, Anti-emetic, GastroenterologyIndication:Ondansetron injection is used to prevent nausea and vomiting caused by cancer medicines (chemotherapy or radiation), including high-dose cisplatin. This...
Product Name:Ondansetron Injection IPBrand Name:GenericStrength:4mg/2ml, 8mg/4ml, 40mg/20mlDosage Form:Liquid Injection (Sterile)Packing:2ml, 4ml AmpouleRoute of Administration:For I.M./I.V. usePack Insert/Leaflet:PIL (Patient Information Leaflet)Documents:COA, MOA, Product Permission, Stability Studies, GMPTherapeutic use:Nausea & Vomiting, Anti-emetic, GastroenterologyIndication:Ondansetron injection is used to prevent nausea and vomiting caused by cancer medicines (chemotherapy or radiation), including high-dose cisplatin. This...
Product Name:N-Acetyl-L-Cysteine Injection BPBrand Name:GENERICStrength:400mg/2ml, 1gm/5ml, 6g/30mlDosage Form:Liquid Injection (Sterile)Packing:1ml, 2ml, 5ml AmpouleRoute of Administration:For IV use only.Pack Insert/Leaflet:PIL (Patient Information Leaflet)Documents:COA, MOA, Product Permission, Stability Studies, GMPTherapeutic use:Antidotes, HepatologyIndication:N-Acetyl-L-Cysteine Injection belongs to a class of drugs called antidotes used to treat Paracetamol (acetaminophen) overdose and prevent liver injury.Storage:Store at...
Product Name:N-Acetyl-L-Cysteine Injection BPBrand Name:GENERICStrength:400mg/2ml, 1gm/5ml, 6g/30mlDosage Form:Liquid Injection (Sterile)Packing:1ml, 2ml, 5ml AmpouleRoute of Administration:For IV use only.Pack Insert/Leaflet:PIL (Patient Information Leaflet)Documents:COA, MOA, Product Permission, Stability Studies, GMPTherapeutic use:Antidotes, HepatologyIndication:N-Acetyl-L-Cysteine Injection belongs to a class of drugs called antidotes used to treat Paracetamol (acetaminophen) overdose and prevent liver injury.Storage:Store at...
Product Name:N-Acetyl-L-Cysteine Injection BPBrand Name:GENERICStrength: 400mg/2ml, 1gm/5ml, 6g/30mlDosage Form:Liquid Injection (Sterile)Packing:1ml, 2ml, 5ml AmpouleRoute of Administration:For IV use only.Pack Insert/Leaflet:PIL (Patient Information Leaflet)Documents:COA, MOA, Product Permission, Stability Studies, GMPTherapeutic use:Antidotes, HepatologyIndication:N-Acetyl-L-Cysteine Injection belongs to a class of drugs called antidotes used to treat Paracetamol (acetaminophen) overdose and prevent liver injury.Storage:Store...
