Contract Manufacturer & Registration Partner for Mexico – EU GMP Approved

Strategic Contract Manufacturing and Regulatory Partnership for the Mexican Market

We present a highly structured, regulatory-compliant, and immediately deployable partnership opportunity for Mexico, designed for pharmaceutical companies, distributors, and institutional suppliers seeking EU GMP and US FDA–approved finished dosage forms with strong regulatory backing and long-term commercial sustainability.

Through our Unit-01 manufacturing facility, we offer ready-to-commercialize neurological and neuromuscular therapies supported by complete dossiers, validated bioequivalence studies, and stability data aligned with Mexican climatic requirements. Our approach combines contract manufacturing excellence with registration and lifecycle support, enabling rapid market entry and scalable growth across Mexico and the broader LATAM region.

READY DOSSIERS

Product Name	Brand Name (TAJ Format)	Therapeutic Category	Dosage Form	Available Strengths	Dossiers Status	BCS Class (Estimate)
Gabapentin	GABATAJ	Antiepileptic, Neuropathic Pain	Capsules	100 mg, 300 mg, 400 mg	Approved ANDA – Dossier Ready	BCS II
Levetiracetam	LEVETAJ	Antiepileptic	Tablets	250 mg, 500 mg, 750 mg, 1000 mg	Approved ANDA – Dossier Ready	BCS I
Gabapentin (New Strength)	GABATAJ-200	Antiepileptic, Neuropathic Pain	Capsules	200 mg	PAS Filing – Dossier Ready	BCS II
Colestipol	COLESTAJ	Lipid-Lowering Agent	Tablets	1 g	Approved ANDA – Dossier Ready	BCS III
Diclofenac Potassium	DICLOTAJ-K	NSAID, Analgesic	Tablets	50 mg	Approved ANDA – Dossier Ready	BCS II
Tizanidine	TIZANTAJ	Muscle Relaxant	Capsules	2 mg, 4 mg, 6 mg	Approved ANDA – Dossier Ready	BCS II
Desipramine	DESIPTAJ	Tricyclic Antidepressant	Tablets	10, 25, 50, 75, 100 mg	Approved ANDA – Dossier Ready	BCS I
Isosorbide Mononitrate ER	ISOMONTAJ-ER	Antianginal	ER Tablets	30 mg, 60 mg, 120 mg	Approved ANDA – Dossier Ready	BCS I
Spironolactone ODT	SPIROTAJ-ODT	Diuretic, Aldosterone Antagonist	ODT Tablets	25 mg	Stability Charged Dec 2024 – Dossier Ready	BCS II
Famotidine	FAMOTAJ	Acid Suppressant (H2 Blocker)	Tablets	20 mg, 40 mg	Stability Charged Feb 2025 – Dossier Ready	BCS III
Pimozide	PIMOZTAJ	Antipsychotic	Tablets	1 mg, 2 mg	Stability Charged Apr 2025 – Dossier Ready	BCS II
Avatrombopag	AVATROTAJ	Thrombopoietin Receptor Agonist	Tablets	20 mg	Stability Charged Apr 2025 – Dossier Ready	BCS II
Bismuth Subcitrate + Metronidazole + Tetracycline	HELICOTAJ	H. pylori Therapy	Capsules	140/125/125 mg	Stability Charged Jun 2025 – Dossier Ready	BCS II
Oxaprozin	OXAPROTAJ	NSAID	Capsules	300 mg	Stability Charged Aug 2025 – Dossier Ready	BCS II
Pyridostigmine	PYRIDOSTAJ	Neuromuscular Agent	Tablets	60 mg	Stability Charged Sep 2025 – Dossier Ready	BCS III

DOSSIERS EXPECTED BY Q1–Q2 2026

Product Name	Brand Name (TAJ Format)	Therapeutic Category	Dosage Form	Available Strengths	Dossiers Status	BCS Class (Estimate)
Brivaracetam	BRIVATAJ	Antiepileptic	Tablets	10, 25, 50, 75, 100 mg	Stability by Nov 2025 – Jan 2026	BCS II
Edoxaban	EDOXATAJ	Anticoagulant	Tablets	15, 30, 60 mg	Stability by Dec 2025 – Mar 2026	BCS IV
Amlodipine + Atorvastatin	AMLOSTAT-TAJ	Antihypertensive + Statin	Tablets	Multiple combinations	Stability by Jan 2026 – Mar 2026	BCS I/II
Mesalamine DR	MESATAJ-DR	Anti-inflammatory (IBD)	DR Tablets	1.2 g	Stability by Jan 2026 – Apr 2026	BCS II

PRODUCTS UNDER DEVELOPMENT – PROTOTYPE COMPLETED

Product Name	Brand Name (TAJ Format)	Therapeutic Category	Dosage Form	Available Strengths	Dossiers Status	BCS Class (Estimate)
Methenamine Hippurate	METHETTAJ	Urinary Antiseptic	Tablets	1 g	EB planned Q2–Q4 2026	BCS I
Orlistat	ORLITAJ	Anti-obesity	Capsules	120 mg	Development Stage	BCS II
Bempedoic Acid	BEMPETAJ	Lipid-Lowering Agent	Tablets	180 mg	Development Stage	BCS II
Obeticholic Acid	OBETATAJ	Hepatobiliary Agent	Tablets	5 mg, 10 mg	Development Stage	BCS II
Mitapivat	MITAPITAJ	Hematology	Tablets	5, 20, 50 mg	Development Stage	BCS II
Semaglutide (Oral)	SEMATAJ	Antidiabetic (GLP-1)	Tablets	3, 7, 14 mg	Development Stage	BCS III
Canagliflozin	CANATAJ	Antidiabetic (SGLT2)	Tablets	100 mg, 300 mg	Development Stage	BCS IV
Sacubitril + Valsartan	SACUVAL-TAJ	Heart Failure	Tablets	24/26, 49/51, 97/103 mg	Development Stage	BCS II
Tolvaptan	TOLVATAJ	Vasopressin Antagonist	Tablets	15–90 mg	Development Stage	BCS II
Rivaroxaban	RIVATAJ	Anticoagulant	Tablets	2.5–20 mg	Development Stage	BCS II
Acitretin	ACITRETAJ	Retinoid	Capsules	10 mg, 25 mg	Development Stage	BCS II
Mirabegron ER	MIRABETAJ-ER	Urology	ER Tablets	25 mg, 50 mg	Development Stage	BCS III
Guanfacine ER	GUANFATAJ-ER	ADHD	ER Tablets	1–4 mg	Development Stage	BCS II
Deferasirox	DEFERTAJ	Iron Chelator	Tablets	90, 180, 360 mg	Development Stage	BCS II
Dabigatran Etexilate	DABIGATAJ	Anticoagulant	Capsules	75, 110, 150 mg	Development Stage	BCS II
Dapagliflozin + Metformin	DAPAMET-TAJ	Antidiabetic	Tablets	5/850, 5/1000 mg	Development Stage	BCS III

PRODUCTS UNDER LITERATURE PHASE

Product Name	Brand Name (TAJ Format)	Therapeutic Category	Dosage Form	Available Strengths	Dossiers Status	BCS Class (Estimate)
Resmetirom	RESMETAJ	Metabolic / NASH	Tablets	60, 80, 100 mg	EB Q4 2026–Q1 2027	BCS II
Cenobamate	CENOBATAJ	Antiepileptic	Tablets	12.5–200 mg	Literature Phase	BCS II
Finerenone	FINERETAJ	Mineralocorticoid Antagonist	Tablets	10, 20, 40 mg	Literature Phase	BCS II
Lumateperone	LUMATAJ	Antipsychotic	Capsules	10.5, 21, 42 mg	Literature Phase	BCS II
Sucroferric Oxyhydroxide	SUCRFETAJ	Phosphate Binder	Chewable Tabs	500 mg	Literature Phase	BCS III
Venlafaxine ER	VENLATAJ-ER	Antidepressant	ER Capsules	37.5–225 mg	Literature Phase	BCS I
Clonidine ER	CLONITAJ-ER	Antihypertensive	ER Tablets	0.1, 0.2 mg	Literature Phase	BCS II
Eliglustat	ELIGLUSTAJ	Gaucher Disease	Capsules	84 mg	Literature Phase	BCS II
Baricitinib	BARICITAJ	JAK Inhibitor	Tablets	1, 2, 4 mg	Literature Phase	BCS III
Upadacitinib ER	UPADATAJ-ER	JAK Inhibitor	ER Tablets	15, 30, 45 mg	Literature Phase	BCS II
Dolutegravir + Lamivudine	DOLULAM-TAJ	Antiretroviral	Bilayer Tablets	50/300 mg	Literature Phase	BCS I
Dutasteride + Tamsulosin	DUTAMTAJ	Urology (BPH)	Capsules	0.5 + 0.4 mg	Literature Phase	BCS II
Bictegravir + Emtricitabine + TAF	BICETAF-TAJ	Antiretroviral	Tablets	50/200/25 mg	Literature Phase	BCS II

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EU GMP & US FDA Approved Finished Dosage Forms Available for Mexico

We currently extend immediate partnership availability for the following high-demand, hospital and chronic care products, manufactured under stringent international quality systems:

Levetiracetam Tablets

A cornerstone therapy in epilepsy management, our Levetiracetam Tablets are manufactured across all globally accepted strengths, ensuring compatibility with Mexican prescribing patterns and institutional tender requirements.

Gabapentin Capsules

Widely prescribed for neuropathic pain and seizure disorders, our Gabapentin Capsules are produced with robust formulation control, consistent dissolution profiles, and multiple pack configurations suitable for both retail and government supply channels.

Pyridostigmine Tablets

Essential for myasthenia gravis and neuromuscular disorders, our Pyridostigmine Tablets are manufactured to ensure dose precision, stability, and long-term supply reliability for specialized care segments.

Each product is fully scalable, allowing seamless expansion from pilot volumes to multi-million unit annual supplies.

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Key Manufacturing & Supply Highlights

Our offering is structured to meet the commercial, regulatory, and operational expectations of the Mexican pharmaceutical market:

• All strengths available to support diverse prescribing and tender needs
• Ready regulatory dossiers with valid Bioequivalence (BE) studies
• US FDA–approved manufacturing facility, reinforcing international compliance credibility
• EU GMP–certified production systems with stringent QA/QC oversight
• Stability data available for Zone II & Zone IVb, aligned with Mexican climatic zones
• Multiple pack styles supported, including blisters, bottles, and institutional packs
• Product-specific shelf life, optimized for distribution and inventory efficiency
• Minimum Order Quantity (MOQ): 100,000 tablets or capsules per strength, ensuring commercial viability while maintaining flexibility

This framework ensures risk-mitigated procurement, predictable supply timelines, and consistent product quality.

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Regulatory & Commercial Framework Tailored for Mexico

Our partnership model is specifically designed to simplify COFEPRIS registration pathways while preserving long-term brand and supply continuity.

Marketing Authorization & Legal Structure

• Taj Pharma remains the Marketing Authorization (MA) Holder
• Eliminates regulatory uncertainty and accelerates approval timelines
• Ensures centralized pharmacovigilance and post-approval compliance

Distribution & Exclusivity Options

• Open to exclusive, country-dedicated distribution rights for Mexico
• LATAM expansion options available where commercially aligned
• Territory protection structured through legally enforceable agreements

Contractual Readiness

• Immediate execution of:
  • Distribution Agreements
  • Exclusivity Agreements
  • License and Supply Agreements (LSA)
• Transparent pricing, volume, and forecast mechanisms embedded contractually

This structure enables partners to focus on commercialization, tender participation, and market expansion, while we ensure regulatory and manufacturing continuity.

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COFEPRIS Registration & Market Entry Support

We actively support partners across the entire Mexican registration lifecycle, providing:

• Company registration roadmap guidance
• Product registration strategy tailored to COFEPRIS requirements
• Gap analysis of local regulatory expectations versus existing dossiers
• Timelines optimization to reduce approval lead time
• Post-approval lifecycle management support

Our regulatory team’s experience ensures predictable outcomes, minimized queries, and efficient dossier acceptance.

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Institutional & Tender-Focused Market Readiness

Our product portfolio is well-positioned for Mexican government, social security, and hospital tenders, with documentation and scalability aligned for institutional procurement.

We invite collaboration on:

• Upcoming government and institutional tenders
• Demand planning for IMSS, ISSSTE, and public health programs
• Long-term supply contracts spanning 3–5 year horizons

Our manufacturing capacity and supply planning are structured to withstand tender volume fluctuations without compromising delivery schedules.

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Commercial Collaboration Inputs Requested

To build a precise, data-driven partnership framework, we welcome inputs on:

• Company registration plans in Mexico
• Product-specific registration roadmap and target timelines
• Annual buying volumes per strength
• Target price expectations / Transfer Price (TP) benchmarks
• Preferred pack styles (retail, hospital, institutional)
• 3–5 year demand forecasts aligned with market expansion plans

These inputs allow us to optimize pricing, capacity allocation, and regulatory prioritization for mutual success.

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Why Partner with Taj Pharma for Mexico

Choosing us as your contract manufacturing and registration partner delivers tangible strategic advantages:

• Proven EU GMP & US FDA manufacturing credibility
• Ready-to-file dossiers reducing time-to-market
• Strong regulatory governance with MA holder continuity
• Flexible exclusivity structures protecting partner investments
• Scalable supply chain supporting long-term growth
• Transparent, compliance-driven partnership ethos

Our focus is not transactional supply, but sustainable market presence and shared value creation across Mexico and LATAM.

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Long-Term Partnership Vision for Mexico & LATAM

We are committed to building transparent, growth-oriented, and enduring collaborations that extend beyond single-product engagements. Our model supports portfolio expansion, lifecycle management, and regional scalability, ensuring partners remain competitive in evolving pharmaceutical landscapes.

We welcome discussions on specific product interests, active inquiries, or strategic expansion plans, and are prepared to engage at your convenience.

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