Pharma Licensing and Regulated Market Collaborations

Taj Pharma India Limited: A Strategic Global Partner for High-Value In-Licensing and Regulated Market Collaborations

Redefining Pharmaceutical Manufacturing Excellence in India

We represent Taj Pharma India Limited, a globally oriented pharmaceutical manufacturer built on regulatory credibility, robust infrastructure, and deep scientific expertise. Our organization is structured to support regulated, semi-regulated, and emerging markets, offering partners a reliable platform for in-licensing, co-development, CDMO, and long-term commercial collaborations.

With strategically developed manufacturing units and a strong product pipeline, we deliver scalable, compliant, and commercially viable solutions for pharmaceutical companies seeking growth in LATAM, EU, North America, and other regulated geographies.

Product Name	Brand Name	Therapeutic Category	Dosage Form	Available Strengths	BCS Class
Aceclofenac + Paracetamol + Serratiopeptidase	Acesertaj	Anti-inflammatory	Tablet	100/325/15 mg	II
Acitretin	Acittaj	Retinoid / Dermatology	Capsule	10, 25 mg	II
Amlodipine + Atorvastatin	AmloAtotaj	Antihypertensive + Statin	Tablet	5/10 to 10/80 mg	II
Avatrombopag	Avatrotaj	Thrombopoietin Receptor Agonist	Tablet	20 mg	II
Bempedoic Acid	Bempotaj	Lipid Lowering Agent	Tablet	180 mg	II
Betamethasone	Betataj	Corticosteroid	Tablet	0.5 mg	I
Bismuth + Metronidazole + Tetracycline	Helitataj	Anti-H. pylori	Capsule	140/125/125 mg	II
Brivaracetam	Brivatag	Antiepileptic	Tablet	10, 25, 50, 75, 100 mg	I
Canagliflozin	Canataj	Antidiabetic (SGLT2)	Tablet	100, 300 mg	II
Cenobamate	Cenotaj	Antiepileptic	Tablet	12.5–200 mg	I
Cetirizine	Cetrataj	Antihistamine	Tablet	10 mg	I
Ciprofloxacin	Ciprotaj	Antibiotic	Tablet	250, 500 mg	IV
Clonazepam	Clonataj	Benzodiazepine	Tablet / Capsule	1, 2 mg	I
Colestipol	Colestaj	Lipid Lowering Agent	Tablet	1 g	II
Deferasirox	Deferataj	Iron Chelator	Tablet	90, 180, 360 mg	II
Desipramine	Desiptaj	Antidepressant (TCA)	Tablet	10–100 mg	I
Diclofenac + Paracetamol + Chlorzoxazone	Diclomtaj	Muscle Relaxant	Tablet	50/325/500 mg	II
Diclofenac Potassium	Diclotaj-K	NSAID / Analgesic	Tablet	50 mg	II
Diphenhydramine HCl	Diphetaj	Antihistamine	Capsule	50 mg	I
Edoxaban	Edoxataj	Anticoagulant	Tablet	15, 30, 60 mg	IV
Escitalopram Oxalate	Escitataj	SSRI Antidepressant	Tablet / Capsule	10 mg	I
Esomeprazole	Esotaj	Proton Pump Inhibitor	Capsule	20 mg	III
Etizolam	Etitaj	Anxiolytic	Tablet / Capsule	0.5 mg	I
Famotidine	Famatag	H2 Receptor Antagonist	Tablet	10, 20 mg	III
Fenbendazole	Fenbetaj	Anthelmintic	Tablet	500 mg	III
Fexofenadine	Fexotaj	Antihistamine	Tablet	120, 180 mg	IV
Finerenone	Finertaj	Mineralocorticoid Antagonist	Tablet	10, 20, 40 mg	II
Gabapentin	Gabataj	Antiepileptic / Neuropathic Pain	Capsule	100, 200, 300, 400 mg	I
Isosorbide Mononitrate ER	Isomonotaj-ER	Antianginal	ER Tablet	30, 60, 120 mg	I
Levetiracetam	Levetaj	Antiepileptic	Tablet	250, 500, 750, 1000 mg	I
Levocetirizine	Levcetaj	Antihistamine	Tablet	5 mg	I
Loperamide	Lopetaj	Antidiarrheal	Tablet / Capsule	2 mg	II
Loratadine	Lorataj	Antihistamine	Tablet	10 mg	II
Lumateperone	Lumetaj	Antipsychotic	Capsule	10.5, 21, 42 mg	II
Mefenamic Acid + Dicyclomine	Mefditaj	Antispasmodic Analgesic	Tablet	250/10 mg	II
Mesalamine DR	Mesataz-DR	IBD Therapy	DR Tablet	1.2 g	II
Methenamine Hippurate	Methitaj	Urinary Antiseptic	Tablet	1 g	I
Mitapivat	Mitataj	Hematology	Tablet	5, 20, 50 mg	I
Nimesulide + Paracetamol	Nimpartaj	Analgesic / Antipyretic	Tablet	100/325 mg	II
Obeticholic Acid	Obetitaj	Hepatobiliary Agent	Tablet	5, 10 mg	II
Ofloxacin	Ofloxataj	Antibiotic	Tablet	200 mg	III
Omeprazole GR	Omezataj	Proton Pump Inhibitor	GR Capsule	20 mg	II
Orlistat	Orlitaj	Anti-obesity	Capsule	60, 120 mg	IV
Oxaprozin	Oxaprotaj	NSAID	Capsule	300 mg	II
Paracetamol	Parataj	Analgesic / Antipyretic	Tablet	500, 650 mg	I
Pimozide	Pimotaj	Antipsychotic	Tablet	1, 2 mg	II
Potassium Chloride ER	Potklotaj-ER	Electrolyte	ER Tablet	600, 750, 1000 mg	I
Pyrantel Pamoate	Pyrantaj	Anthelmintic	Tablet	250, 500 mg	III
Pyridostigmine	Pyridotaj	Anticholinesterase	Tablet	60 mg	III
Resmetirom	Resmetaj	NASH Therapy	Tablet	60, 80, 100 mg	II
Rivaroxaban	Rivarotaj	Anticoagulant	Tablet	2.5, 10, 15, 20 mg	II
Sacubitril + Valsartan	Sacuvaltaj	Heart Failure Therapy	Tablet	24/26, 49/51, 97/103 mg	III
Semaglutide (Oral)	Semataz	Antidiabetic (GLP-1)	Tablet	1.5–14 mg	III
Sucroferric Oxyhydroxide	Sucroftaj	Phosphate Binder	Chewable Tablet	500 mg	III
Tizanidine	Tizatag	Muscle Relaxant	Capsule	2, 4, 6 mg	II
Tolvaptan	Tolvatag	ADPKD / Hyponatremia	Tablet	15–90 mg	II

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WHO-GMP & Health Canada Approved Manufacturing: Unit-01 Overview

Our Unit-01 manufacturing facility stands as a cornerstone of our regulated market strategy. This site is:

• Approved by WHO-GMP and Health Canada
• EU-GMP audit triggered, with targeted approval by Q2-2026
• Designed for high-value, complex, and differentiated oral solid dosage formulations
• Supported by validated processes, robust quality systems, and regulatory-ready documentation

Unit-01 is purpose-built to support ANDA-approved products, dossier-ready molecules, and advanced development programs, making it an ideal platform for LATAM-focused in-licensing and exclusive market entry strategies.

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Dedicated Oral Solid Dosage Manufacturing: Unit-02 Capabilities

Our Unit-02 facility is a dedicated oral solid dosage (OSD) manufacturing site, engineered for efficiency, scale, and compliance.

Key Highlights of Unit-02

• Annual capacity:
  • 1.2 billion tablets
  • 400 million capsules
• Designed for regulated and semi-regulated markets
• Integrated with strong in-house R&D
• Complete end-to-end dossier development capabilities, including:
  • CTD / eCTD modules
  • Bioequivalence coordination
  • Stability studies
  • Lifecycle management support

This unit enables us to support high-volume generics, lifecycle extensions, and portfolio expansions for partners seeking consistent quality and supply reliability.

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LATAM Priority In-Licensing Product Grid – Unit-01

We have curated a LATAM-focused, high-value product grid aligned with therapeutic demand, regulatory feasibility, and commercial scalability. All products are developed with global regulatory alignment and are suitable for exclusive country or regional in-licensing.

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ANDA Approved | Dossier Ready Products

These products are regulatory-ready and ideal for immediate market entry:

• Gabapentin Capsules – 100 mg, 200 mg, 300 mg, 400 mg
• Levetiracetam Tablets – 250 mg, 500 mg, 750 mg, 1000 mg
• Colestipol Tablets – 1 g
• Diclofenac Potassium Tablets – 50 mg
• Tizanidine Capsules – 2 mg, 4 mg, 6 mg
• Desipramine Tablets – 10 mg to 100 mg
• Isosorbide Mononitrate ER Tablets – 30 mg, 60 mg, 120 mg

These molecules address neurology, cardiovascular, pain management, and psychiatric segments, offering strong prescription traction and stable long-term demand in LATAM markets.

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Stability Ongoing | Dossier Ready Portfolio

Products in this category are advanced-stage assets with stability studies in progress and complete regulatory documentation:

• Pimozide Tablets – 1 mg, 2 mg
• Avatrombopag Tablets – 20 mg
• Bismuth Subcitrate + Metronidazole + Tetracycline Capsules – 140/125/125 mg
• Oxaprozin Capsules – 300 mg
• Pyridostigmine Tablets – 60 mg

These products are positioned for near-term submission, supporting partners looking for pipeline acceleration without early development risk.

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Dossiers Expected Q1–Q2 2026

Our mid-term pipeline includes high-impact cardiovascular, CNS, and gastroenterology products with dossiers expected in Q1–Q2 2026:

• Brivaracetam Tablets – 10 mg to 100 mg
• Edoxaban Tablets – 15 mg, 30 mg, 60 mg
• Amlodipine + Atorvastatin Tablets – full strength range
• Mesalamine Delayed Release Tablets – 1.2 g

These assets provide first-mover or early-entry advantages in multiple LATAM territories.

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Advanced Development & Prototype Completed Molecules

We maintain an innovation-driven development pipeline focused on complex generics and specialty products:

• Methenamine Hippurate – 1 g
• Orlistat – 120 mg
• Bempedoic Acid – 180 mg
• Obeticholic Acid – 5 mg, 10 mg
• Mitapivat – 5 mg, 20 mg, 50 mg
• Semaglutide Tablets
• Canagliflozin – 100 mg, 300 mg
• Sacubitril + Valsartan – all strengths
• Tolvaptan – 15 mg to 90 mg
• Rivaroxaban – 2.5 mg to 20 mg
• Acitretin – 10 mg, 25 mg
• Deferasirox – 90 mg, 180 mg, 360 mg

These products are designed for high regulatory barriers, premium pricing, and differentiated positioning.

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Literature-Based & Early-Stage Strategic Assets

We also offer early-stage collaboration opportunities for companies seeking long-term portfolio building:

• Resmetirom
• Cenobamate
• Finerenone
• Lumateperone

These molecules are ideal for co-development, risk-sharing, and future-focused partnerships.

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Flexible Collaboration Models for LATAM Markets

We support customized business models aligned with partner strategy and market dynamics:

• In-Licensing with Exclusive Country or Regional Rights
• CMO / CDMO Manufacturing Projects
• Co-Development Programs
• Profit-Sharing Arrangements
• Royalty-Based & Long-Term Strategic Alliances

Our commercial frameworks are designed to ensure mutual value creation, supply security, and regulatory confidence.

Product Name	Brand Name	Therapeutic Category	Dosage Form	Available Strengths	BCS Class
Acebrophylline + Acetylcysteine	Aceacetaj	Bronchodilator / Mucolytic	Tablet / Capsule	100 mg + 600 mg	II
Aspirin + Atorvastatin + Clopidogrel	Aspartaj-CV	Antiplatelet / Lipid Lowering	Tablet	As per market standard	II
Dapagliflozin + Metformin HCl ER	Dapametaj-XR	Antidiabetic (SGLT2 + Biguanide)	ER Tablet	10/500 mg	II
Dapagliflozin + Metformin + Sitagliptin	Dapmetasitaj	Antidiabetic (Triple Combination)	Tablet	10/1000/100 mg	II
Methylcobalamin + Pregabalin	Methypretaj	Neuropathic Pain	Capsule	As per market standard	I
Pregabalin	Pregataj	Neuropathic Pain / Antiepileptic	Capsule	50 mg, 75 mg, 150 mg	I
Telmisartan + Amlodipine	Telamlotaj	Antihypertensive	Tablet	As per market standard	II
Ticagrelor	Ticagretaj	Antiplatelet	Tablet	90 mg	IV

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Next Steps for Strategic Engagement

To advance discussions efficiently, we invite potential partners to share:

• Target LATAM countries
• Annual volume forecasts (3–5 years)
• Preferred pack style and presentation
• Target pricing or last tender price (where applicable)
• Preferred commercial model (exclusive, royalty, or supply-based)

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A Differentiated LATAM Portfolio with Regulatory Leverage

We believe our Unit-01 LATAM portfolio delivers clear differentiation, accelerated regulatory pathways, and scalable commercial potential. Backed by robust manufacturing, scientific depth, and global compliance, Taj Pharma India Limited stands as a trusted partner for sustainable growth in regulated and emerging markets.