Strategic Manufacturer and Registration Partner for Regulated and Semi-Regulated Markets

End-to-End Dossier, BE Studies, and Market Authorization Solutions

We operate as a fully integrated manufacturer and registration partner supporting pharmaceutical market entry across Africa, Mexico, and the wider LATAM region. Our platform is designed for companies, distributors, and institutional buyers seeking rapid regulatory approvals, stable commercial supply, and long-term product lifecycle management.

We deliver end-to-end regulatory and technical solutions covering finished dosage form manufacturing, dossier preparation (eCTD, CTD, ACTD, and country-specific formats), Drug Master Files (open and closed parts), bioequivalence studies, BTIF form filling, AMV documentation, and Common Technical Document publishing and maintenance.

Our regulatory systems are built for speed, compliance, and reproducibility across multiple jurisdictions while maintaining strict alignment with ICH, WHO, US FDA, and EU regulatory expectations.

Product NameBrand Name (TAJ Format)Therapeutic CategoryDosage FormAvailable StrengthsBCS Class (Estimate)
ParacetamolParacotajAnalgesic, AntipyreticTablet (Scored)500 mgClass I
Losartan PotassiumLosartajAntihypertensive (ARB)Tablet (Scored)50 mgClass III
Vitamin B ComplexBcomtajNutritional SupplementTabletB-Complex CombinationClass III
HydrochlorothiazideHydrotajDiuretic, AntihypertensiveTablet25 mgClass IV
AtenololAtenotajBeta-Blocker, AntihypertensiveTablet (Scored)50 mgClass III
LoratadineLoratajAntihistamineTablet10 mgClass II
Sitagliptin PhosphateSitatjAntidiabetic (DPP-4 Inhibitor)Tablet50 mgClass III
TrihexyphenidylTrihetajAntiparkinsonianTablet2 mgClass I
RivaroxabanRivotajAnticoagulantTablet20 mgClass II
BicalutamideBicaltajAntiandrogen, AnticancerCoated Tablet50 mgClass II
MethyldopaMethytajAntihypertensiveTablet250 mgClass III
PrazosinPrazotajAlpha-Blocker, AntihypertensiveTablet5 mgClass I
CarvedilolCarvetajBeta-Blocker, AntihypertensiveTablet25 mgClass II
ProchlorperazineProctajAntiemetic, AntipsychoticTablet5 mgClass I
Azithromycin USPAzitotajAntibiotic (Macrolide)Capsule / Tablet250 mgClass II
PromethazinePrometajAntihistamine, AntiemeticTablet25 mgClass I
Metformin + GliclazideMetglitajAntidiabetic CombinationTablet500 mg + 80 mgClass III
MesalazineMesatajAnti-inflammatory (IBD)Tablet400 mgClass IV
MetronidazoleMetrotajAntibiotic, AntiprotozoalIV Infusion0.5% w/v, 100 mLClass I
MemantineMemtajAnti-Alzheimer’sTablet10 mgClass I
Darunavir + RitonavirDaruritajAntiretroviral (HIV)Tablet / Capsule800 mg + 100 mgClass II
HydrocortisoneHydrotaj-10CorticosteroidTablet10 mgClass I
Omeprazole IVOmetaj-IVProton Pump InhibitorInjection (Ampoule)40 mg / 5 mLClass II
Lamivudine + ZidovudineLamzitajAntiretroviral (HIV)Tablet150 mg + 300 mgClass I
VancomycinVancotajAntibiotic (Glycopeptide)Injection (Vial)500 mgClass III
MeropenemMerotajAntibiotic (Carbapenem)Injection (Vial)1 gClass III
VecuroniumVecutajNeuromuscular BlockerInjection (Vial)10 mgClass I

EU-GMP and US-FDA Approved Manufacturing Infrastructure

All finished dosage forms are manufactured at our Unit-01 facility under:

  • EU-GMP compliance
  • US-FDA approval
  • WHO-GMP certification
  • PIC/S aligned quality systems

Our manufacturing platform supports:

  • Immediate-release tablets
  • Hard gelatin capsules
  • Controlled and sustained-release formulations
  • Moisture-sensitive and low-dose products
  • High-potency solid orals (where applicable)

Each product is supported with:

  • Validated manufacturing processes
  • Process validation batches
  • Finished product specifications
  • Stability data (Zone II and Zone IVb)
  • Product-specific shelf life assignments
  • Multiple commercial pack styles

Immediate Partnership Opportunities for Mexico and LATAM

We are currently offering immediate regulatory and commercial partnerships for the following EU-GMP approved finished dosage forms manufactured at our Unit-01 facility:

Levetiracetam Tablets

An antiepileptic agent indicated for partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures.

  • All international strengths available
  • Ready CTD and eCTD dossiers
  • Valid bioequivalence studies
  • Stability data for Zone II and Zone IVb
  • Multiple pack styles and shelf-life configurations

Gabapentin Capsules

A neuropathic pain and anticonvulsant therapy indicated for postherpetic neuralgia and partial seizures.

  • All strengths available
  • Valid BE studies
  • Complete regulatory modules
  • Commercial-scale validation
  • Product-specific stability programs

Pyridostigmine Tablets

A cholinesterase inhibitor indicated for myasthenia gravis and neuromuscular transmission disorders.

  • Internationally acceptable strengths
  • Full CTD/eCTD dossiers
  • Bioequivalence documentation
  • Long-term and accelerated stability data

Regulatory Dossier Capabilities

We provide full lifecycle regulatory support for:

  • eCTD
  • CTD
  • ACTD
  • Country-specific dossier formats
  • Regional adaptations and translations
  • Labeling localization
  • Patient Information Leaflets
  • SmPC and prescribing information

Each product dossier includes:

  • Module 1: Regional administrative and legal documentation
  • Module 2: Quality, non-clinical, and clinical summaries
  • Module 3: Complete CMC data
  • Module 4: Non-clinical reports (where required)
  • Module 5: Clinical study reports and BE documentation

All dossiers are audit-ready and formatted to meet COFEPRIS, ANVISA, INVIMA, DIGEMID, ARCSA, SAHPRA, and African NMRA requirements.


Drug Master File (DMF) – Open and Closed Part Support

We provide complete API DMF support for all products, including:

  • Open Part (Applicant’s Part)
  • Closed Part (Restricted Part)
  • Letter of Access
  • DMF updates and lifecycle management
  • Variation handling and deficiency responses

Our DMFs are maintained in line with:

  • US FDA DMF guidelines
  • European ASMF requirements
  • ICH Q7, Q11, and Q12

Bioequivalence (BE) Studies and Clinical Documentation

All offered products are supported with:

  • Valid BE studies conducted at accredited CROs
  • GCP-compliant protocols
  • Statistical analysis reports
  • Bioanalytical validation reports
  • Ethics approvals and subject consent documentation
  • Clinical study reports (CSR)

We support:

  • Waiver strategies where applicable
  • BCS-based biowaivers
  • Post-approval BE maintenance
  • Additional BE studies for new markets

Stability Data – Zone II and Zone IVb

Each product includes:

  • Long-term stability data
  • Accelerated stability data
  • Intermediate stability data (where required)
  • Photostability (where applicable)

Stability studies are conducted under:

  • ICH Q1A(R2)
  • ICH Q1B
  • WHO TRS guidelines

This ensures immediate submission readiness for:

  • Africa
  • Mexico
  • Central America
  • South America
  • ASEAN
  • CIS

Regulatory and Commercial Framework – Mexico

Our Mexico partnership framework is structured to ensure regulatory clarity, commercial stability, and long-term exclusivity security.

Marketing Authorization Strategy

  • We remain the Marketing Authorization (MA) Holder
  • Optional MA transfer models available
  • Country-dedicated MA holding for institutional tenders

Distribution and Exclusivity Models

  • Exclusive country-dedicated distribution rights for Mexico
  • LATAM regional exclusivity options
  • License and Supply Agreements (LSA)
  • Distribution Agreements
  • Private Label and Branded supply

COFEPRIS Registration Support

We provide a complete COFEPRIS registration roadmap including:

  • Company registration strategy
  • Product registration strategy
  • Gap assessment
  • Dossier localization
  • Legal representation coordination
  • Deficiency handling
  • Approval follow-ups

Commercial Supply Capabilities

We support scalable commercial supply with:

  • MOQ: 100,000 tablets or capsules per strength
  • Batch size optimization
  • Rolling forecasts
  • Tender-linked production scheduling
  • Multi-year supply agreements
  • Reserved production slots

Pack Styles and Shelf Life Configurations

We offer:

  • Alu-Alu blisters
  • PVC/PVDC blisters
  • HDPE bottles
  • Amber glass bottles
  • Child-resistant closures
  • Hospital bulk packs

Each product supports:

  • Market-specific labeling
  • Multilingual leaflets
  • Country-specific serialization
  • Product-specific shelf life

Government and Institutional Tender Support

We actively support partners with:

  • Tender product mapping
  • Technical compliance matrices
  • Sample supplies
  • Tender pricing strategies
  • Dossier alignment with tender requirements
  • Post-award regulatory maintenance

Long-Term Partnership Model

Our partnerships are designed around:

  • Transparency
  • Territory protection
  • Stable pricing models
  • Regulatory continuity
  • Commercial scalability
  • Multi-product portfolio expansion

We invite partners to share:

  • Upcoming government or institutional tenders
  • Company registration plans
  • Product registration timelines
  • Annual buying volume projections
  • Target price or expected transfer price
  • Required pack styles
  • 3–5 year demand forecasts

Manufacturing and Corporate Address

TAJ PHARMA INDIA LTD.
Plot No. 1019,
Village Sarigam, G.I.D.C., Road No. 10,
District Valsad, Gujarat, India 396155