We are a globally oriented pharmaceutical manufacturer in India, specializing in Analgesic, Anti-Inflammatory, and CNS (Central Nervous System) formulations, delivering EU GMP–compliant, US FDA–approved, and internationally regulated finished dosage forms to regulated and semi-regulated markets worldwide.

Operating from our state-of-the-art Unit-01 manufacturing facility in Gujarat, India, we support partners across LATAM, Africa, ASEAN, CIS, Middle East, and Europe with a robust portfolio of high-quality oral solid and specialty CNS products supported by ready regulatory dossiers, bioequivalence studies, and long-term stability data.

Our strategic objective is to establish long-term, transparent, and growth-oriented partnerships with marketing authorization holders, distributors, tender participants, and institutional buyers seeking a reliable contract manufacturing organization (CMO) and finished dosage supplier from India.

Product NameBrand Name (TAJ Format)Therapeutic CategoryDosage FormAvailable StrengthsBCS Class (Estimate)
ParacetamolParaTAJAnalgesic / AntipyreticTablets (Scored)500 mgI
Losartan PotassiumLosarTAJAntihypertensive (ARB)Tablets (Scored)50 mgII
Vitamin B ComplexVitaB-TAJMultivitamin / Nutritional SupplementTabletsMultistrengthN/A
HydrochlorothiazideHydroTAJThiazide Diuretic / AntihypertensiveTablets25 mgIV
AtenololAtenoTAJBeta-Blocker / AntihypertensiveTablets (Scored)50 mgIII
LoratadineLoraTAJAntihistamine / Anti-allergicTablets10 mgII
Sitagliptin PhosphateSitaTAJAntidiabetic (DPP-4 Inhibitor)Tablets50 mgIII
TrihexyphenidylTrihexTAJAntiparkinsonian / AnticholinergicTablets2 mgI
RivaroxabanRivaTAJOral Anticoagulant (Factor Xa Inhibitor)Tablets20 mgII
BicalutamideBicaTAJAntiandrogen / AnticancerFilm-Coated Tablets50 mgII
MethyldopaMethyTAJAntihypertensive (Central Acting)Tablets250 mgIII
PrazosinPrazoTAJAlpha-1 Blocker / AntihypertensiveTablets5 mgII
CarvedilolCarveTAJBeta-Blocker / AntihypertensiveTablets25 mgII
ProchlorperazineProchloTAJAntiemetic / AntipsychoticTablets5 mgII
Azithromycin USPAzithroTAJMacrolide AntibioticCapsules / Tablets250 mgII
PromethazinePromeTAJAntihistamine / AntiemeticTablets25 mgII
Metformin + GliclazideMetGlyTAJAntidiabetic CombinationTablets500 mg + 80 mgIII
MesalazineMesaTAJAnti-inflammatory (IBD)Tablets400 mgIII
Metronidazole (IV)MetroTAJ-IVAntibacterial / AntiprotozoalIV Infusion0.5% (100 mL)I
MemantineMemaTAJAnti-Alzheimer / NMDA AntagonistTablets10 mgII
Darunavir + RitonavirDaruRitoTAJAntiretroviral (Protease Inhibitor Combo)Tablets / Capsules800 mg + 100 mgII
HydrocortisoneHydroCortiTAJCorticosteroidTablets10 mgI
Omeprazole (IV)OmezTAJ-IVProton Pump InhibitorInjection (Ampoule)40 mg / 5 mLIII
Lamivudine + ZidovudineLamiZidoTAJAntiretroviral Combination (NRTIs)Tablets150 mg + 300 mgIII
VancomycinVancoTAJGlycopeptide AntibioticInjection (Vial)500 mgIII
MeropenemMeroTAJCarbapenem AntibioticInjection (Vial)1 gIII
VecuroniumVecuTAJNeuromuscular Blocking AgentInjection (Vial)10 mgIII

EU GMP & US FDA Approved Manufacturing Infrastructure

Our Unit-01 facility is designed, validated, and operated under the most stringent international quality systems.

Key compliance credentials include:

  • EU GMP Certified Manufacturing Facility
  • US FDA Approved Production Site
  • WHO-GMP, PIC/S, ISO 9001:2018 compliant
  • Dedicated production blocks for CNS, Analgesic, and Anti-Inflammatory products
  • In-house Quality Control (QC) and Quality Assurance (QA) laboratories
  • Validated equipment, utilities, HVAC, and computerized systems
  • End-to-end batch traceability and data integrity systems

We manufacture products strictly under ICH Q7, Q8, Q9, and Q10 guidelines, ensuring consistency, reproducibility, and regulatory defensibility for all export markets.


Immediate Partnership Opportunity – Mexico & LATAM

We are pleased to inform qualified pharmaceutical companies, distributors, and MA holders of immediate partnership opportunities for Mexico, with potential extension to LATAM markets, for the following EU GMP-approved finished dosage forms, manufactured at our Unit-01 facility:

Available Products for Mexico Registration & Distribution

  • Levetiracetam Tablets – Antiepileptic / CNS
  • Gabapentin Capsules – Neuropathic Pain / CNS
  • Pyridostigmine Tablets – Myasthenia Gravis / Neuromuscular Disorder

Key Product Highlights

Each of the above products is supported by a complete technical and regulatory data package.

Product advantages include:

  • All strengths available for commercial flexibility
  • Ready CTD dossiers with valid Bioequivalence (BE) studies
  • US FDA approval for the manufacturing site
  • Stability data available for Zone II and Zone IVb
  • Multiple pack styles supported (blister, Alu-Alu, bottles)
  • Product-specific shelf life supported by long-term and accelerated studies
  • Minimum Order Quantity (MOQ): 100,000 tablets or capsules per strength

These products are immediately deployable for COFEPRIS submission, government tenders, and private market launches in Mexico.


Regulatory & Commercial Framework – Mexico (COFEPRIS)

We offer a flexible, partner-centric regulatory and commercial model aligned with Mexican pharmaceutical regulations and international best practices.

Framework highlights:

  • Taj Pharma remains the Marketing Authorization (MA) Holder
  • Open to exclusive, country-dedicated distribution rights across Mexico
  • LATAM expansion rights negotiable for strategic partners
  • Ready to sign:
    • Distribution Agreements
    • Exclusivity Agreements
    • License and Supply Agreements (LSA)

We also provide full technical and regulatory assistance for:

  • Company registration roadmap in Mexico
  • Product registration strategy under COFEPRIS
  • Dossier localization and translation support
  • Regulatory lifecycle management

Why Partner with Taj Pharma India Ltd.

1. Proven Expertise in CNS, Analgesic & Anti-Inflammatory Products

We are among India’s most experienced manufacturers of CNS and pain-management formulations, supplying both branded and generic products to regulated markets.

Our therapeutic expertise includes:

  • Antiepileptics (Levetiracetam, Gabapentin)
  • Neuromuscular agents (Pyridostigmine)
  • Analgesics & Anti-Inflammatories
  • Psychiatric & Neurological therapies

2. Dossier-Driven Market Entry

Our products are dossier-ready, enabling partners to shorten time-to-market and minimize regulatory risk.

Our regulatory packages include:

  • CTD Modules 1–5
  • Bioequivalence study reports
  • Stability studies (Zone II & IVb)
  • Process validation
  • Method validation
  • Finished product specifications
  • Reference standards and impurity profiles

3. Scalable Commercial Supply Capability

We support both institutional tenders and private market distribution with:

  • High-volume batch sizes
  • Flexible packaging formats
  • Custom branding
  • Private label programs
  • Country-specific artworks
  • Serialization and traceability

4. Transparent Long-Term Partnership Model

We believe in structured, transparent, and sustainable partnerships.

We actively seek inputs from our Mexico partners on:

  • Upcoming government and institutional tenders
  • Company registration plan in Mexico
  • Product registration roadmap and timelines
  • Commercial interest details, including:
    • Annual buying volume
    • Target price / expected transfer price (TP)
    • Required pack style
    • 3–5 year demand forecast

Global Manufacturing & Export Capabilities

Our export-oriented manufacturing ecosystem supports:

  • Regulated market exports
  • Semi-regulated market registrations
  • Branded generics and institutional supply
  • Contract manufacturing and toll manufacturing
  • Technology transfer and scale-up

We already serve partners across:

  • LATAM
  • Africa
  • ASEAN
  • Middle East
  • CIS
  • Europe

Manufacturing Site Details – Taj Pharma India Ltd.

Taj Pharma India Ltd.
Plot No.1019, Vill. – Sarigam, G.I.D.C.
Road No. 10, Dist. – Valsad
Gujarat, India 396155

Plant Location:
https://g.co/kgs/WrD9gQQ