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Oral Solids, Semi-Solids and Liquids
Code | Product | Dosage Form | Strengths | EUGMP Facility | CTD Dossier | BE Study |
|---|---|---|---|---|---|---|
ATM00 | Amoxicillin Clavulanic Acid | Tablets | 250/125 mg, 500/125 mg, 875/125 mg, 500/62.5 mg, 1000/125 mg | Yes | Yes | Yes |
GDE00 | Diclofenac Potassium | Sachets | 50 mg | Yes | Yes | Biowaiver |
ITM00 | Ibuprofen | Tablets | 200 mg, 400 mg, 600 mg | Yes | Yes | Yes |
NCM00 | Nitrofurantoin | Capsules | 50 mg, 100 mg | Yes | Yes | Yes |
STX00 | Sevelamer Carbonate | Tablets | 800 mg | Yes | Yes | Yes |
Injectables
Code | Product | Dosage Form | Strengths | EUGMP Facility | CTD Dossier | BE Study |
|---|---|---|---|---|---|---|
AII00 | Amoxicillin Clavulanic Acid | Powder for Inj. | 600 mg, 1.2 gm | Yes | Yes | N/A |
DIC10 | Diclofenac Sodium | Liquid Inj. | 25 mg/mL | Nov-25 | Yes | Yes |
LIC10 | Lidocaine (Preservative Free) | Liquid Inj. | 1 %, 2 % | Nov-25 | Yes | N/A |
MIS10 | Methylprednisolone Sodium Succinate | Powder for Inj. | 20 mg, 40 mg, 125 mg, 500 mg | Yes | Yes | N/A |
TIS10 | Tranexamic Acid | Liquid Inj. | 500 mg/5mL, 1000 mg/10mL | Yes | Yes | N/A |
Branded Products
Code | Brand | Product | Dosage Form | Strengths/Composition |
|---|---|---|---|---|
DPU02 | PS Fastify | Diclofenac | Hydrogel Patch | 140 mg |
LPU00 | PS Lidosol | Lidocaine | Hydrogel Patch | 4 %, 5 % |
HPU00 | PS Valex | Herbal Pain Relief - Regular | Plaster Based Hypoallergenic Adhesive Patch | Wintergreen Oil 7%, Menthol 7%, Camphor 7%, Eucalyptus Oil 1%, Clove Oil 1% |
PPU01 | PS Valex | Feminine Pain Relief | Plaster Based Hypoallergenic Adhesive Patch | Menthol 10%, Eucalyptus Oil 5% |
MPU00 | PS Valex | Menthol | Plaster Patch | 5 %, 6.5 % |
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