Regulatory Affairs

Regulatory affairs at TajPharma act as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation.

Related Products:

Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.

Irbesartan Tablets USP 300mg

Irbesartan Tablets USP 300mg Technical Specification: Product Name: Irbesartan Tablets USP Brand Name: Generic Strength: 75mg, 150mg, 300mg 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 […]

Potassium Iodide Tablets USP 65mg (TAJZOSAT)

Potassium Iodide Tablets USP 65mg Technical Specification: Product Name: Potassium Iodide Tablets, USP 65mg Brand Name: TAJZOSAT Strength: 65mg, 100mg, 130mg, 200mg Dosage Form: Film-coated tablets Packing: 10s Blisters, 14s Blisters, 20s Blisters 30 Tab Bottle Route of Administration: For Oral Use Only Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: […]

Ropivacaine Injection I.P. 7.5mg/ml (0.75%)

Ropivacaine Injection I.P. 7.5mg/ml (0.75%) Technical Specification: Product Name: Ropivacaine Injection I.P. Brand Name: Generic Strength: 2mg/ml (0.2%), 7.5mg/ml (0.75%), 5mg/ml (0.5%) Dosage Form: Liquid Injection (Sterile) Packing: 4ml, 20ml Ampoule, 50ml Vial Route of Administration: For epidurally (via lumbar or thoracic route) Pack Insert/Leaflet: PIL (Patient Information Leaflet) Documents: COA, MOA, Product Permission, Stability […]

Botulinum Toxin Type A 50 Units

Botulinum Toxin Type A 50 Units Technical Specification: Product Name: Botulinum Toxin Type A Brand Name: Generic Strength: 50 Units, 100 Units, 200 Units Dosage Form: Lyophilized Dry Powder Injection (Sterile) *Preservative Free Packing: 1 Vial Route of Administration: For Intramuscular & Intradermal use Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory […]

Mefenamic Acid 250mg Capsules Taj Pharma

Glimepiride & Metformin Hydrochloride Sustained Release Tablets 1mg/500mg (GLUCOTAJ-MET-SR) Taj Pharma

Name of the medicinal product: Glimepiride & Metformin Hydrochloride Sustained Release Tablets 1mg/500mg (GLUCOTAJ-MET-SR) Taj Pharma Glimepiride & Metformin Hydrochloride Sustained Release Tablets 2mg/500mg (GLUCOTAJ-MET-SR) Taj Pharma Glimepiride & Metformin Hydrochloride Sustained Release Tablets 1mg/1000mg (GLUCOTAJ-MET-SR) Taj Pharma Glimepiride & Metformin Hydrochloride Sustained Release Tablets 2mg/1000mg (GLUCOTAJ-MET-SR) Taj Pharma 2. Qualitative and quantitative composition:a) Each […]

Mesalamine Delayed-Released Tablets USP 400mg Taj Pharma

NAME OF THE MEDICINAL PRODUCT Mesalamine Delayed-Released Tablets USP 400mg Taj Pharma Mesalamine Delayed-Released Tablets USP 800mg Taj Pharma Mesalamine Delayed-Released Tablets USP 1.2g Taj Pharma QUALITATIVE AND QUANTITATIVE COMPOSITION a) Each Delayed Released Tablet contains: Mesalamine USP…………………….400mg|b) Each Delayed Released Tablet contains: Mesalamine USP…………………….800mg b) Each Delayed Released Tablet contains: Mesalamine USP…………………….1.2g PHARMACEUTICAL FORM […]

Pantoprazole (EC) and Dompiridone (SR) Capsules 40mg/30mg (PANTOTAJ – DSR) Taj Pharma

Name of the medicinal product Pantoprazole (EC) and Dompiridone (SR) Capsules 40mg/30mg (PANTOTAJ – DSR) Taj Pharma Composition Each hard gelatin Capsule contains: Pantoprazole Sodium IP Equibvalent to Pantoprazole 40mg (As enteric coated granules) Domperidone IP 30mg (As sustained release granules) Excipients q.s. 3.PHARMACEUTICAL FORM: Capsule for oral administration 4.CLINICAL PARTICULARS: 4.1 Therapeutic indications: Gastro-esophageal […]

Rabeprazole Sodium & Domperidone SR Capsules 20mg & 30mg (RABTAJ-DSR) Taj Pharma

COMPOSITION: (a) Each hard gelatin capsule contains; Rabeprazole Sodium IP (as enteric coated granules) 20mg + Domperidone IP (as sustained release granules) 30mg (b) Each hard gelatin capsule contains; Rabeprazole Sodium IP (as enteric coated granules) 20mg + Domperidone IP (as sustained release granules) 10mg DOSAGE FORM: Hard gelatin capsules DESCRIPTION: Rabtaj DSR capsule is […]

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Regulatory Affairs