Strategic In-Licensing & Collaboration Opportunities – Taj Pharma India Ltd.
(Unit-01: EU-GMP, US-FDA, UK-MHRA, Health Canada Approved)

At Taj Pharma India Ltd., we stand at the forefront of global pharmaceutical partnerships through strategic in-licensing and collaboration opportunities. With our Unit-01 facility accredited by EU-GMP, US-FDA, UK-MHRA, and Health Canada, we provide a world-class platform for companies seeking high-quality, regulatory-compliant manufacturing alliances. Our state-of-the-art facility is equipped to support innovative formulation development, contract manufacturing, and dossier licensing for both regulated and semi-regulated markets worldwide.


World-Class Manufacturing Infrastructure

Taj Pharma’s Unit-01 facility is strategically designed for oral solid dosage (OSD) manufacturing excellence. With a massive annual capacity of 2.2 billion tablets and 400 million capsules, we deliver scalability and consistency in every batch. Our manufacturing operations are supported by a dedicated team of 25+ formulation scientists, state-of-the-art analytical laboratories, and validated manufacturing systems meeting the most stringent global regulatory standards.

Our infrastructure meets full compliance with ICH Q8–Q10 guidelines, ensuring robust process development, quality risk management, and lifecycle-based product control. Each stage of production — from raw material sourcing to packaging — adheres to PIC/S, WHO-GMP, and ISO 9001:2018 standards, reinforcing our position as a trusted global pharmaceutical partner.


Comprehensive In-Licensing Product Portfolio

We invite strategic partners to explore a curated portfolio of high-value molecules that are ANDA approved or in advanced stages of development. These molecules are ideal for partnerships targeting regulated markets, semi-regulated regions, and LATAM territories. Each product is developed under the highest standards of quality, bioequivalence, and regulatory readiness.

💊 Taj Pharma Licensing Product Grid

Sr. No.Product NameDosage Form / StrengthRegulatory / StatusHighlights
1Levetiracetam Tablets250mg / 500mg / 750mg / 1000mgANDA Approved; BiowaiverDossier ready; all ICH stability zones supported; 36-month shelf life
2Gabapentin Capsules USP100mg / 300mg / 400mgANDA Approved; BE availableBE study for 300mg; SRA dossier ready
3Brivaracetam Tablets10mg / 25mg / 50mg / 75mg / 100mgPrototype developedNext-gen CNS molecule; BE initiation possible
4Edoxaban Tablets15mg / 30mg / 60mgPrototype developedOral anticoagulant; dossier under preparation
5Avatrombopag Tablets20mgPrototype developedThrombocytopenia segment; niche molecule
6Pyridostigmine Tablets60mgPrototype developed; BE ready by Dec 2025Neuromuscular segment; scale-up ready
7Sacubitril + Valsartan Tablets24/26mg, 49/51mg, 97/103mgPrototype developedCardiovascular; formulation optimized and stability initiated
8Mesalamine DR Tablets1.2gPrototype developedGastroenterology; BE-ready formulation
9Methenamine Hippurate Tablets1gPrototype developedAnti-infective / UTI prophylaxis
10Orlistat Capsules120mgPrototype developedAnti-obesity; formulation optimized

Each of these formulations is optimized for long-term stability (24–36 months) and supported with comprehensive regulatory dossiers (CTD/eCTD format), ensuring seamless product registration and market entry.


Regulatory Excellence and Global Compliance

Our Unit-01 facility’s strong regulatory framework ensures consistent compliance with global standards. The plant is regularly audited by leading regulatory authorities, including US-FDA, UK-MHRA, and Health Canada. The ongoing EU-GMP audit (expected completion Q2 2026) further enhances our global recognition and opens broader market access.

Facility Credentials:

  • Regulatory Approvals: EU-GMP (in progress), US-FDA, UK-MHRA, Health Canada
  • Stability Zones Supported: I, II, III, IVa, IVb
  • Shelf Life: Typically 24 to 36 months (Zone IVb & II data available)
  • Manufacturing Capabilities: Tablets, Capsules, Coated Forms, Modified Release Formulations
  • Packaging Configurations: Alu-Alu, Blister, HDPE, and Bottles per international requirements

Our Quality Assurance (QA) and Regulatory Affairs (RA) teams work seamlessly to ensure that every dossier meets stringent ICH, WHO, and regional regulatory norms, enabling faster approvals and market launches.


Strategic Collaboration Models

Taj Pharma offers flexible partnership models designed to meet the diverse needs of global clients. Our collaborative approach ensures mutual growth and optimized market presence.

1. In-Licensing / Out-Licensing Partnerships

We offer dossier-based product licensing opportunities for regulated and emerging markets. Our ready-to-file and ANDA-approved dossiers enable rapid product commercialization.

2. Co-Development / Joint Development

Our co-development model provides shared investment and risk benefits, combining Taj Pharma’s formulation expertise with partner market access for accelerated growth.

3. Contract Manufacturing (CMO) / Contract Development (CDMO)

We provide complete end-to-end manufacturing solutions, from technology transfer and scale-up to commercial production and packaging, ensuring high-quality, cost-effective supply chains.

4. Dossier Support and Technical Documentation

We offer comprehensive dossier support in CTD/eCTD format, complete with bioequivalence data, stability data, and validation reports for seamless regulatory submissions.


Innovation and R&D Capabilities

Our R&D Centre serves as the backbone of innovation. Backed by 25+ formulation scientists, the unit specializes in novel drug delivery systems (NDDS), controlled-release formulations, and biowaiver-based product development. Taj Pharma’s focus on technology transfer, QbD-based design, and scale-up studies ensures that every product is scientifically robust and commercially viable.

The R&D team operates under GLP-certified conditions, equipped with analytical instrumentation such as HPLC, GC, FTIR, and Dissolution Testers, ensuring precision in formulation development and analytical validation. Our bioequivalence and clinical study partnerships across India and the EU strengthen our dossier readiness for global submissions.


Future-Ready Vision: Aligning for 2026–2028

As part of our long-term global strategy, Taj Pharma invites collaboration for your 2026–2028 product pipeline. We seek alignment in product portfolio planning, regulatory pathways, and commercial strategy.

We request our partners to share:

  • 3–5 year volume projections
  • Preferred pack configurations and labeling style
  • Target or last bid price (for tender/private market alignment)
  • Expected transfer price or licensing model (binding/non-binding)

By aligning regulatory, commercial, and supply strategies early, we ensure competitive pricing, efficient supply chain execution, and sustained market growth.


Commitment to Global Health and Quality

At Taj Pharma, our mission is to enhance global healthcare accessibility through reliable partnerships and quality-driven manufacturing. Our collaborative approach ensures that every partnership is built on trust, transparency, and technical excellence. Whether through in-licensing, co-development, or contract manufacturing, we deliver value that extends beyond product supply — empowering our partners to achieve long-term success in highly competitive markets.

We remain committed to upholding the highest standards of ethical manufacturing, sustainable sourcing, and scientific innovation, ensuring that every product we deliver contributes positively to global health outcomes.


Contact Taj Pharma India Ltd.

Taj Pharma India Ltd. – Unit-01
Plot No.1019, Vill. Sarigam, G.I.D.C., Road No. 10,
Dist. Valsad, Gujarat, India – 396155
Certifications: WHO-GMP, ISO 9001:2018, PIC/S, GLP, US-FDA, UK-MHRA, Health Canada
Email: info@tajpharma.com
Call: +91 84484 44095 | WhatsApp: +91 7400009975 / 7400009976
Website: www.tajpharmaindia.com