Manufacturer & Registration Partner for Africa

LATAM – High-Quality EU GMP Finished Dosage Forms from India

Strategic Pharmaceutical Manufacturing and Regulatory Partnership Opportunities

We present a high-impact pharmaceutical partnership opportunity for companies seeking a reliable manufacturer, regulatory dossier partner, and long-term supply ally for Africa, Mexico, and the broader LATAM region. Backed by EU GMP-compliant manufacturing, US FDA approval, and ready-to-file regulatory dossiers, we enable seamless market entry, product registration, and commercial scale-up.

Our offering integrates end-to-end regulatory support, world-class manufacturing, and commercial flexibility, ensuring rapid deployment of high-demand molecules across regulated and semi-regulated markets.


About Taj Pharma India Ltd. – Global-Grade Manufacturing Excellence

We are Taj Pharma India Ltd., a WHO-GMP, EU GMP-aligned, and US FDA-approved pharmaceutical manufacturer based in Gujarat, India. Our Unit-01 manufacturing facility is engineered for high-volume, export-grade production of solid oral dosage forms.

Manufacturing Site
Plot No.1019, Vill. Sarigam, G.I.D.C., Road No. 10,
Dist. Valsad, Gujarat, India – 396155
Certifications: WHO-GMP, EU-GMP aligned, ISO 9001:2018, PIC/S, GLP
US FDA Inspection Status: Approved

Product NameBrand Name (TAJ Format)Therapeutic CategoryDosage FormAvailable StrengthsBCS Class (Estimate)
DoxycyclineDOXYTAJAntibiotic (Tetracycline)Capsule100 mgI
AzithromycinAZITAJAntibiotic (Macrolide)Tablet500 mgII
CiprofloxacinCIPROTAJAntibiotic (Fluoroquinolone)Tablet250 mg, 500 mgIV
NorfloxacinNORFLOTAJAntibiotic (Fluoroquinolone)Tablet400 mgIV
Trimethoprim + SulphamethoxazoleCOTRIMTAJAntibiotic (Sulfonamide)TabletPediatric, 80/400 mg, 160/800 mgII
AmoxycillinAMOXTAJAntibiotic (Penicillin)Capsule500 mgIII
Amoxycillin + Clavulanic AcidAMOXCLAVTAJAntibiotic (Penicillin Combo)Tablet500 mg + 125 mgIII
PantoprazolePANTOTAJAntiulcer (PPI)Tablet40 mgIII
OmeprazoleOMEPTAJAntiulcer (PPI)Capsule20 mgIII
FurazolidoneFURATAJAntiprotozoalTablet100 mgII
Chlorpheniramine MaleateCPMTAJAntihistamineTablet4 mgI
Cetirizine HydrochlorideCETRITAJAntihistamineTablet10 mgI
Levocetirizine HydrochlorideLEVOCETTAJAntihistamineTablet5 mgI
ParacetamolPARATAJAnalgesic / AntipyreticTablet500 mgI
MetronidazoleMETROTAJAntiprotozoal / AntibioticTablet400 mgI
Dicyclomine HydrochlorideDICLOTAJAntispasmodicTablet10 mgII
Calcium Carbonate + Vitamin D3CALVITTAJCalcium SupplementTablet1250 mg + 250 IUII
Vitamin B-ComplexBCOMPTAJMultivitaminTabletAs per formulaIII
OndansetronONDANTAJAntiemeticTablet4 mgII
Diclofenac SodiumDICLOFENTAJNSAIDTablet50 mgII
IbuprofenIBUTAJNSAIDTablet400 mgII
Ranitidine HClRANITAJAntiulcer (H2 Blocker)Tablet150 mgIII
MetforminMETFOTAJAntidiabeticTablet500 mgIII
AmlodipineAMLOTAJAntihypertensive (CCB)Tablet5 mgI
TelmisartanTELMITAJAntihypertensive (ARB)Tablet40 mgII
Ascorbic Acid (Vitamin C)VITCTAJVitamin SupplementTablet500 mgI
Folic AcidFOLITAJHematinicTablet5 mgI
Salbutamol SulphateSALBTAJBronchodilatorTablet4 mgI
Product NameBrand Name (TAJ Format)Therapeutic CategoryDosage FormAvailable StrengthsBCS Class (Estimate)
Risperidone + TrihexyphenidylRISPTAJ-THAntipsychotic / AntiparkinsonianTablets2 mg + 2 mg (and more)II
RopiniroleROPITAJAnti-ParkinsonTablets0.5 mg, 2 mgII
Sertraline + AlprazolamSERTATAJ-AAntidepressant / AnxiolyticTablets25 mg + 0.25 mgN/A
SertralineSERTATAJSSRI AntidepressantTablets25 mg, 50 mg, 100 mgI
Sodium ValproateVALPROTAJAntiepileptic / Mood StabilizerTablets / Syrup200 mg, 300 mg, 500 mg SR; SyrupI
ThioridazineTHIOTAJAntipsychoticTablets10 mg, 25 mgI
TianeptineTIANETAJAntidepressantTablets12.5 mgI
TizanidineTIZATAJMuscle RelaxantTablets1 mgII
TofisopamTOFITAJAnxiolyticTablets50 mg, 100 mgII
TopiramateTOPITAJAntiepileptic / Migraine ProphylaxisTablets25 mg, 50 mg, 100 mgII
TrifluoperazineTRIFLUTAJAntipsychoticTablets5 mgI
Trifluoperazine + TrihexyphenidylTRIFLUTAJ-THAntipsychotic CombinationTablets5 mg + 2 mgN/A
Trifluoperazine + Trihexyphenidyl + ChlorpromazineTRIFLUTAJ-TCAntipsychotic CombinationTablets5 mg + 2 mg + 50 mgN/A
TrihexyphenidylTRIHEXTAJAntiparkinsonianTablets2 mgI
VenlafaxineVENLATAJSNRI AntidepressantTablets / Capsules37.5 mg, 75 mgI
VinpocetineVINPOTAJCerebral Vasodilator / NootropicTablets5 mgII
VortioxetineVORTITAJAntidepressantTablets5 mg, 10 mg, 20 mgI
BrivaracetamBRIVATAJAntiepilepticTablets50 mgI
Product NameBrand Name (TAJ Format)Therapeutic CategoryDosage FormAvailable StrengthsBCS Class (Estimate)
Amino Acid CombinationsAminotajNutritional SupplementCapsules/TabletsVarious strengthsN/A
Benfotiamine & Other NutrientsBenfotaJNeuro/Nutritional SupplementCapsules/TabletsVarious strengthsN/A
Calcium Carbonate + Vitamin D3CalciTAJ-D3Calcium SupplementTablets1250 mg + 250 IUII
Calcium Carbonate + AlfacalcidolCalciTAJ-ABone HealthTablets/Capsules650 mg + 0.25 mcgII
Calcium Carbonate + CalcitriolCalciTAJ-CTBone HealthTablets/Capsules650 mg + 0.25 mcgII
Calcium Citrate + Vit K2-7 + MecobalaminCalciTAJ-KMBone & Neuro HealthTabletsStandard combinationsN/A
Calcium Citrate + CalcitriolCalciTAJ-CCBone HealthTablets1000 mg + 0.25 mcgII
Carbonyl IronIronTAJHematinicCapsules/TabletsVarious strengthsIII
Ferrous Ascorbate + Folic AcidFerroTAJ-FHematinicTablets/CapsulesVarious strengthsIII
GinsengGinsenTAJAdaptogenCapsulesVarious strengthsN/A
L-MethylfolateMethylTAJNeuro/NutritionalTabletsVarious strengthsI
Methylcobalamin CombinationsMecoTAJNeuro SupplementTablets/CapsulesVarious strengthsIII
LycopeneLycoTAJAntioxidantCapsulesVarious strengthsN/A
Methylcobalamin + Alpha Lipoic AcidMecoTAJ-ALNeuropathyCapsules/TabletsVarious strengthsIII
Pyridoxal PhosphatePyriTAJ-PVitamin B6TabletsVarious strengthsI
Vitamin C CombinationsVitCTAJImmunity SupplementTablets500 mg & combinationsI
BaclofenBacloTAJMuscle RelaxantTablets10, 20, 60 mg SRI
AgomelatineAgomeTAJAntidepressantTablets25 mgII
Alprazolam SRAlpraTAJ-SRAnxiolyticTablets0.25, 0.5, 1, 1.5 mg SRI
AmisulprideAmisuTAJAntipsychoticTablets50, 100, 200 mgIV
AmitriptylineAmitriTAJAntidepressantTablets10, 25, 50, 75 mg SRI
AmoxapineAmoxaTAJAntidepressantTablets50, 100 mgII
AripiprazoleAripiTAJAntipsychoticTablets5, 10, 15, 20 mgIV
Betahistine HClBetaTAJAnti-VertigoTablets8, 16, 24, 48 mg SRIII
Bupropion ERBuproTAJ-ERAntidepressantTablets150 mgII
CarbamazepineCarbaTAJAntiepilepticTablets200 mg, 200 mg SRII
ChlorpromazineChloroTAJAntipsychoticTablets25, 50, 100 mgI
Cinnarizine + DomperidoneCinnaTAJ-DAnti-VertigoTablets25 + 10 mgN/A
CiticolineCitiTAJNeuroprotectiveTablets500 mgIII
ClobazamClobaTAJAntiepilepticTablets5, 10 mgII
ClomipramineClomiTAJAntidepressantTablets25, 50 mgII
ClonazepamClonaTAJAnxiolyticTablets0.25, 0.5 mgII
ClozapineClozaTAJAntipsychoticTablets25, 50, 100 mgII
DuloxetineDuloTAJSNRI AntidepressantCapsules20, 30, 40 mgII
DesvenlafaxineDesvenTAJAntidepressantTablets50, 100 mgI
Divalproex SodiumDivaTAJ-SRAntiepilepticTablets250, 500 mg SRI
DonepezilDoneTAJAnti-AlzheimerTablets5, 10 mgI
Donepezil + MemantineDoneTAJ-MAnti-DementiaTablets5 + 5 mgN/A
DothiepinDothiTAJAntidepressantTablets25, 75 mgI
DoxepinDoxeTAJAntidepressantCapsules25 mgI
EscitalopramEscitaTAJSSRITablets10 mgI
Escitalopram + ClonazepamEscitaTAJ-CAntidepressantTablets10 + 0.25/0.5 mgN/A
Escitalopram + FlupentixolEscitaTAJ-FAntidepressantTablets10 + 0.5 mgN/A
Etizolam CombinationsEtizoTAJAnxiolyticTabletsStandard combinationsN/A
FlunarizineFlunaTAJAnti-MigraineTablets5, 10 mgII
FluoxetineFluoxTAJSSRICapsules20, 40, 60 mgI
GabapentinGabaTAJNeuropathic PainCapsules100, 300, 400 mgIII
HaloperidolHaloTAJAntipsychoticTablets1.5, 5, 10 mgI
ImipramineImiTAJAntidepressantTablets25, 75 mgII
LacosamideLacoTAJAntiepilepticTablets50, 100 mgI
LamotrigineLamoTAJAntiepilepticTablets25, 50, 100 mgII
LevetiracetamLeviTAJAntiepilepticTablets250, 500, 750 mgI
LorazepamLoraTAJAnxiolyticTablets0.5, 1, 2, 3 mgI
MirtazapineMirtaTAJAntidepressantTablets7.5, 15 mgII
ModafinilModaTAJCNS StimulantTablets100, 200 mgII
OlanzapineOlanTAJAntipsychoticTablets2.5, 5, 7.5, 10 mgII
OxcarbazepineOxcarbaTAJAntiepilepticTablets150, 300, 450, 600 mg SRII
ParoxetineParoTAJSSRITablets12.5, 25 mgII
QuetiapineQuetiTAJAntipsychoticTablets25, 50, 100, 200, 300 mgII
RisperidoneRisperTAJAntipsychoticTablets2, 3 mgII

Immediate Partnership Scope – Mexico and LATAM

We are currently extending exclusive and semi-exclusive partnerships for Mexico and selected LATAM markets for the following EU GMP-manufactured finished dosage forms:

  • Levetiracetam Tablets
  • Gabapentin Capsules
  • Pyridostigmine Tablets

These products are available with:

  • All commercially relevant strengths
  • Multiple pack styles
  • Product-specific shelf life
  • Validated manufacturing processes
  • Zone II and Zone IVb stability data
  • Ready regulatory dossiers
  • Valid BE studies
  • US FDA manufacturing approval

Key Commercial Highlights

  • All strengths available across all molecules
  • Ready CTD / eCTD dossiers with BE data
  • US FDA-approved manufacturing site
  • Long-term stability data for Zone II and Zone IVb
  • Flexible pack styles (Alu-Alu, Blister, HDPE Bottles)
  • Product-specific shelf life
  • MOQ: 100,000 tablets or capsules per strength
  • Scalable production capacity for institutional tenders
  • Dedicated country-specific labeling and artwork support

Comprehensive Regulatory Dossier Capabilities

We deliver complete regulatory documentation support tailored for Africa, Mexico, and LATAM.

Dossier Formats Supported

  • eCTD (electronic Common Technical Document)
  • CTD (Common Technical Document)
  • ACTD (ASEAN Common Technical Dossier)
  • Country-specific dossier formats

Regulatory Modules Delivered

  • Module 1: Country-specific administrative data
  • Module 2: Quality Overall Summary (QOS)
  • Module 3: Complete CMC (API + FDF)
  • Module 4: Non-clinical summaries (where required)
  • Module 5: BE study reports

DMF Support – Open and Closed Parts

We provide Drug Master Files (DMFs) to support regulatory submissions and variations:

  • Open Part DMF for applicant review
  • Closed Part DMF directly to regulatory authorities
  • API manufacturer traceability
  • ICH-compliant impurity profiling
  • Stability and validation datasets

Bioequivalence (BE) Studies and BTIF Support

All offered products are supported by:

  • Valid Bioequivalence (BE) studies
  • ICH GCP-compliant CROs
  • Reference product alignment
  • Statistical bioequivalence confirmation

We also support:

  • BTIF form filling
  • Product master file compilation
  • Risk assessment and variation documentation

AMV and CDP – Post-Approval Lifecycle Management

We offer structured post-approval regulatory lifecycle support, including:

  • AMV (Administrative Marketing Variations)
  • CDP (Change Development Protocols)
  • Change control management
  • Stability extension submissions
  • Artwork and labeling updates

Regulatory and Commercial Framework – Mexico

Our partnership structure ensures regulatory stability, brand continuity, and commercial exclusivity.

Marketing Authorization Ownership

  • Taj Pharma remains the MA Holder
  • Ensures regulatory continuity
  • Eliminates post-transfer regulatory risk
  • Protects product lifecycle integrity

Distribution and Exclusivity Rights

We are open to:

  • Exclusive, country-dedicated distribution rights
  • Mexico-only or LATAM-wide territory exclusivity
  • Performance-linked exclusivity extensions

Commercial Agreements Available

  • Distribution Agreements
  • Exclusivity Agreements
  • LSA – License and Supply Agreements
  • Long-term supply contracts
  • Tender supply frameworks

COFEPRIS Regulatory Support – Mexico

We provide a structured regulatory roadmap for COFEPRIS product registration.

Registration Strategy Services

  • Product classification confirmation
  • Dossier gap assessment
  • COFEPRIS formatting and localization
  • Translator-certified documentation
  • Submission coordination
  • Query response management

Africa and LATAM Expansion Capabilities

Beyond Mexico, we support parallel market registration across:

  • West Africa
  • East Africa
  • Southern Africa
  • Central America
  • Caribbean markets
  • South America

Our regulatory intelligence ensures:

  • Country-specific module alignment
  • Authority-driven labeling compliance
  • Fast-track tender readiness

Pack Styles and Supply Customization

We support multiple packaging configurations:

  • Alu-Alu Blisters
  • PVC-Alu Blisters
  • HDPE Bottles
  • Bulk institutional packs
  • Tender packs

Shelf life and labeling are customized per market.


Commercial Engagement Inputs Requested

To activate exclusivity and supply planning, we invite partners to share:

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

Why Partner with Taj Pharma

  • EU GMP and US FDA-approved facility
  • Ready regulatory dossiers
  • Valid BE studies
  • Stability data for tropical climates
  • Long-term regulatory lifecycle support
  • Tender-ready production capacity
  • Exclusive distribution frameworks
  • Transparent pricing and volume commitments

Long-Term Partnership Vision

We pursue growth-driven, transparent, and sustainable alliances that create mutual value, secure supply reliability, and enable regional pharmaceutical access expansion.

We welcome regional inquiries, government tender leads, and dossier deployment requests.


Contact Details

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