Advancing Affordable Generics

Making Medicines Accessible Across Australia

MedTAS partners with leading global manufacturers to bring high-quality, affordable generic medicines to patients — navigating every step from patent strategy to PBS listing.

100+
Approvals on ARTG
15+
Global Partners
💊
PBS Listed Products
GMP Compliant Manufacturers
End-to-End Commercialisation
Australian Market Focus
Robust Pipeline
ARTG Portfolio
Post-Market Surveillance
PBS Listed Products
GMP Compliant Manufacturers
End-to-End Commercialisation
Australian Market Focus
Robust Pipeline
ARTG Portfolio
Post-Market Surveillance

Our Journey

In just five years, MedTAS has grown from a bold idea into one of Australia's most dynamic generic pharmaceutical companies — driven by deep expertise, strategic partnerships, and an unwavering focus on patient access.

  • 2020MedTAS founded in Sydney with a clear mission: make essential generic medicines affordable for every Australian
  • 2021Acquired first product portfolio, establishing a foundation for rapid growth in the Australian generics market
  • 2022First product registered on the ARTG — a landmark moment proving our regulatory capability and speed
  • 2023Secured our first PBS-listed product, enabling subsidised patient access through pharmacies nationwide
  • 2024Entered into a strategic partnership for oncology supportive care — expanding into high-impact therapeutic areas
  • 2025Established MedTAS as a registered entity in New Zealand, laying the groundwork for future trans-Tasman expansion

We believe affordable medicine isn't a privilege — it's a right

MedTAS was born from a bold conviction: that no patient in Australia should ever go without essential medicine because of cost. We're not just another pharmaceutical distributor — we're a purpose-driven team of regulatory strategists, commercial specialists, and supply chain experts who wake up every day determined to break down the barriers between world-class generics and the patients who need them.

From our Sydney headquarters, we partner with the best GMP-certified manufacturers on the planet, navigate the most complex regulatory pathways in the region, and deliver medicines that meet the highest standards of quality at prices that put patients first. This is more than business. This is what we were built to do.

Access

Every Australian deserves affordable, quality medicines without exception

Integrity

Complete transparency in every regulatory, commercial, and supply chain decision

Precision

Pharmaceutical compliance demands accuracy — we never cut corners on quality or regulation

Partnership

Invested in your product's entire lifecycle — we succeed only when our partners succeed

End-to-end pharmaceutical services

From molecule identification to patient delivery, we manage every critical step in the lifecycle of a generic medicine in Australia.

Product Identification & Scouting

We continuously scan the global pipeline and patent landscape to identify high-value generic opportunities aligned with Australian market demand.

  • Patent cliff analysis and monitoring
  • Market demand and therapeutic gap assessment
  • Competitive landscape evaluation
  • Molecule prioritisation and selection

Regulatory Affairs & TGA Registration

Our regulatory team manages TGA dossier submissions from CTD compilation through to ARTG listing and post-approval variations.

  • CTD Module 1–5 compilation
  • Bioequivalence study design oversight
  • TGA evaluation management
  • Post-approval change notifications

IP & Patent Strategy

We conduct thorough freedom-to-operate analyses and develop launch strategies that balance speed to market with robust IP protection.

  • Freedom-to-operate (FTO) assessments
  • Patent expiry timeline monitoring
  • Paragraph IV / challenge strategies
  • Risk mitigation and legal coordination

PBS Reimbursement & Pricing

We prepare PBAC submissions, negotiate pricing under the National Health Act, and manage ongoing PBS listing obligations.

  • PBAC submission preparation
  • Price negotiation and benchmarking
  • Statutory price reduction management
  • PBS Code and brand name coordination

Supply Chain & Distribution

From GMP-certified manufacturers globally to temperature-controlled logistics across Australia, we manage the entire supply chain.

  • GMP manufacturer sourcing and auditing
  • Cold chain and ambient logistics
  • Batch release and quality control
  • Wholesaler and pharmacy distribution

Pharmacovigilance & Compliance

Our PV team maintains robust post-market safety monitoring systems ensuring ongoing TGA compliance.

  • Adverse event reporting (ICSR)
  • Periodic safety update reports (PSURs)
  • Risk management plans (RMPs)
  • Signal detection and safety analysis

From molecule to market in five steps

Our proven end-to-end model takes a generic medicine from identification through to the pharmacy shelf — efficiently, compliantly, and at the right price.

1

Identify

Scan patent landscapes and market data for the highest-value generic opportunities in the Australian market.

2

Develop

Partner with GMP manufacturers to develop formulations and conduct bioequivalence studies to international standards.

3

Register

Compile CTD dossiers and manage TGA evaluation from submission through to ARTG listing approval.

4

Reimburse

Prepare PBAC submissions and negotiate PBS pricing so patients can access medicines at subsidised rates.

5

Deliver

Manage supply chain logistics, distribution, pharmacovigilance, and ongoing compliance post-launch.

Growing our impact on Australian healthcare

Our robust pipeline and expanding portfolio reflect our commitment to addressing unmet demand for affordable generics across key therapeutic categories.

100+
Approvals on the Australian Register of Therapeutic Goods
20+
Molecules in active development pipeline
15+
Global manufacturing and development partners
8
Major therapeutic areas covered

Current Portfolio Highlights

Our existing ARTG-registered portfolio spans critical therapeutic areas with a strong focus on chronic disease management:

  • Cardiovascular agents including ACE inhibitors, ARBs, and statins
  • CNS medicines covering antidepressants and anticonvulsants
  • Endocrine therapies for diabetes and thyroid disorders
  • Anti-infective agents including broad-spectrum antibiotics
  • Gastrointestinal products including PPIs and antispasmodics

Pipeline Focus Areas

Our development pipeline targets high-demand molecules approaching patent expiry with a focus on:

  • Complex generics including modified-release formulations
  • Oncology supportive care medicines
  • Respiratory combination therapies
  • Niche and first-to-market generic opportunities
  • Biosimilar pathway evaluation for select biologics

Delivering generics across critical health categories

We strategically focus on therapeutic areas where affordable generic alternatives have the greatest impact on patient outcomes and healthcare sustainability.

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Cardiovascular

Antihypertensives, statins, anticoagulants, ACE inhibitors, ARBs, beta-blockers, and heart failure therapies for Australia's leading cause of death.

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Central Nervous System

SSRIs, SNRIs, anxiolytics, anticonvulsants, and neuropathic pain agents — addressing mental health at scale across Australia.

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Respiratory

Bronchodilators, inhaled corticosteroids, LABA/ICS combinations, and leukotriene modifiers for asthma and COPD management.

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Anti-Infectives

Penicillins, cephalosporins, macrolides, fluoroquinolones, antifungals, and antiviral agents for community and hospital settings.

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Endocrinology

Metformin, sulfonylureas, DPP-4 inhibitors, thyroxine, and hormonal therapies for diabetes and metabolic disorders.

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Musculoskeletal

NSAIDs, DMARDs, bisphosphonates, and muscle relaxants for arthritis, osteoporosis, and chronic pain management.

🔎

Oncology Supportive

Antiemetics (5-HT3 antagonists), corticosteroids, analgesics, and supportive care medicines used alongside chemotherapy.

💊

Gastroenterology

Proton pump inhibitors, H2 blockers, antispasmodics, aminosalicylates, and IBD therapies for digestive health conditions.

What sets us apart

In a competitive generics landscape, our combination of regulatory depth, commercial agility, and global networks delivers results that larger organisations often can't match.

01

Speed to Market

Our lean, experienced team moves faster than traditional pharma. We've taken products from dossier submission to PBS listing in under 18 months — well ahead of industry averages. Our pre-submission strategy means fewer TGA queries and faster evaluations.

02

Deep Regulatory Expertise

Our regulatory affairs specialists have collectively managed 200+ TGA submissions. We understand the nuances of the ARTG registration process, PBAC submission cycles, and the regulatory quirks that can delay or derail a generic launch.

03

Global-to-Local Bridge

We translate between international manufacturers and Australian market realities. Our partners get a single point of contact who understands both global GMP standards and local TGA expectations — eliminating friction and miscommunication.

04

Lifecycle Ownership

We don't hand off. From patent analysis through to pharmacovigilance, we own the product lifecycle end-to-end. One team accountable for quality, compliance, supply continuity, and commercial performance — no gaps, no finger-pointing.

05

Commercial Agility

Our size is our advantage. We evaluate new opportunities, make go/no-go decisions, and mobilise within weeks — not quarters. For manufacturers seeking a nimble Australian partner with real decision-making authority, MedTAS is the right fit.

06

Patient-First Pricing

Every pricing decision is anchored to a simple question: does this improve patient access? We work to secure the most competitive PBS pricing possible while maintaining commercially sustainable margins for our manufacturing partners.

Your molecule deserves a partner who treats it like their own

You've invested years developing your product. You need an Australian partner who brings the same level of care, rigour, and urgency to getting it registered, reimbursed, and into patients' hands. That's exactly what MedTAS does.

One Partner, Complete Market Entry

Stop coordinating between regulatory consultants, IP lawyers, pricing advisors, and distributors. MedTAS handles the entire journey — from TGA dossier to pharmacy shelf — under one roof, with one accountable team.

We Move Fast — Because Timing Is Everything

In generics, the difference between first-to-market and fifth-to-market is the difference between success and irrelevance. Our lean team makes decisions in days, not months. No committees, no bureaucracy — just experienced people who know the Australian market inside out.

Built on Transparency, Not Lock-In

We believe great partnerships are built on trust, not fine print. You'll always know where your product stands — from regulatory milestones to commercial performance. We share data, flag risks early, and treat your business as if it were ours.

Commercially Aligned, Patient Focused

We structure partnerships that work commercially for both sides while keeping patient access at the centre. Our PBS pricing expertise ensures your product reaches the widest possible patient population at sustainable margins.

"We don't just distribute your product — we champion it. From the first regulatory strategy meeting to the day it reaches a patient, your molecule gets our full attention, expertise, and commitment."

— MedTAS Leadership Team
Who We Partner With
Global generic manufacturers seeking Australian market entry
API producers looking for a finished-dose commercialisation partner
Innovator companies divesting off-patent or mature brands
Contract manufacturers with capacity seeking an Australian sponsor

Experienced professionals driving our vision

Our leadership team brings together decades of combined experience across pharmaceutical development, TGA regulatory affairs, PBS reimbursement, patent law, and Australian market access.

MG

Mohit Gupta

Founder & CEO

Mohit founded MedTAS with a clear mission: to make quality generic medicines affordable and accessible for every Australian. With a career spanning pharmaceutical commercialisation, regulatory strategy, and business development, he leads company vision, global partnerships, and market expansion. His entrepreneurial drive and deep understanding of the Australian generics landscape have been the driving force behind MedTAS's rapid growth from startup to a 100+ registration portfolio in just five years.

AL

Alastair Lomas

Chief Operating Officer

Alastair is a senior executive with over two decades of leadership experience across the pharmaceutical, healthcare, and FMCG sectors. Previously Finance Director and CFO at Amgen Australia, he has held senior roles at Vertex Pharmaceuticals, Alexion, and Alphapharm. A Harvard-trained executive leader, Chartered Accountant (Australia & UK), and AICD graduate, Alastair brings exceptional strategic, financial, and operational capability to MedTAS's growth trajectory.

VP

Vikas Patil

Head of Regulatory Affairs

Vikas leads MedTAS's regulatory strategy and TGA submission pipeline. With deep expertise in CTD dossier compilation, bioequivalence study oversight, and ARTG registration management, he has been instrumental in building MedTAS's 100+ approval portfolio. His experience spans global regulatory frameworks across Australia, Europe, and Asia, enabling seamless coordination between international manufacturing partners and Australian regulatory requirements.

Ready to bring your generic medicine to the Australian market?

Whether you're a global manufacturer seeking Australian market entry, a biotech exploring generic licensing, or a healthcare stakeholder looking for cost-effective alternatives — MedTAS is your strategic partner from dossier to dispensary.

Contact Our TeamExplore Services

We'd love to hear from you

Whether you have a partnership enquiry, a product question, or want to explore how MedTAS can support your market entry — reach out and we'll get back to you within 24 hours.

Patient Safety — Adverse Event & Product Complaint Reporting

If you have experienced an unexpected reaction, side effect, or quality issue with a MedTAS product, please contact our Pharmacovigilance team immediately. Reporting adverse events is critical to patient safety and helps us work with the TGA to protect the Australian community. Healthcare professionals and consumers can report directly.

Pharmacovigilance Phone
02 8313 5453
Pharmacovigilance Email
pv@medtas.com.au

Important: Patients should always consult their doctor for medical advice about adverse events. MedTAS takes the protection of personal data seriously and may contact you for follow-up information. Reports are forwarded to the TGA as required under the Therapeutic Goods Act 1989.

Office Address

Medtas Pty Ltd
Level 11, 347 Kent Street
Sydney CBD, NSW 2000, Australia

General Enquiries

Phone: 1300 414 543
Email: info@medtas.com.au

Business Details

ABN: 726 44270860
Website: www.medtas.com.au

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