INTERNATIONAL BUSINESS
Delivering Indian Pharmaceutical Excellence Globally
Exporting to 50+ countries since the 1970s, Gufic's International Business Division is one of the fastest-growing arms of the company, built on advanced lyophilization technology, global regulatory credentials, and a growing regulated market presence.
Manufacturing Network
Gufic’s global scale—highlighted by a 50-country reach and an annual production of 100 million+ injectables—solidifies its reputationas a premier Indian leader in sterile manufacturing.
FACTS & FIGURES
Global Presence Stats
Countries Exported
To
Vials Per Month
Capacity
Products in
Pipeline
Regulated Market
Filings in Progress
What we do
A Pioneer in Advanced Injectables
Specializing in Small Volume Parenterals — both liquid and lyophilized — Gufic brings pioneering automated lyophilization technology and a broad portfolio of Anti-Infectives, Anti-Fungals, IVF, Cardiac, and GI to healthcare systems worldwide.
OUR PORTFOLIO
Complex Molecules. Global Reach.
Dual Chamber Technology
Introducing Dual Chamber Bags and Dual Chamber Syringes to international markets, providing a safer closed delivery system for unstable drugs with zero human intervention.
Aesthetic Medicine
Expanding Botulinum Toxin presence globally through in-licensing of fillers and biostimulators.
Liposomal Amphotericin B
The major growth driver for Gufic across both ROW and regulated markets, addressing a critical unmet need in antifungal therapy.
REGULATED MARKETS
Complex Molecules. Global Reach.
Direct EU presence through Gufic Ireland Limited, securing Marketing Authorization
Gufic Ireland has initiated filings of 10+ products across 18 EU markets including UK
Participation in UK NHS tenders reinforcing credibility in regulated public healthcare
Recent UK-MHRA approvals supporting commercialisation of advanced injectables
OUR INFRASTRUCTURE
Built for Global Compliance
Navsari Facility
Accredited by FDA Philippines, MOH Ecuador, PPB Kenya, NAFDAC, Nigeria, Ethiopia, TFDA Tanzania. Capacity of 3.0 million vials per month with batch sizes of 50 to 700L and 2 to 30 ml fills.
Indore Facility
A USD 50 million investment dedicated to Lyophilized Formulations, Novel Drug Delivery Systems (NDDS), and Biologicals. Designed to meet EU cGMP and US-FDA standards for regulated international markets. Capacity of 60 million lyophilized and 72 million liquid injections annually.
REGULATORY EXCELLENCE
Numbers That Speak for Themselves
A strong regulatory framework with approvals from leading global authorities and an extensive global product registration pipeline.
PRODUCTS REGISTERED GLOBALLY
PRODUCTS UNDER REGISTRATION
PLANNED SUBMISSIONS FY27
EXPECTED APPROVALS FY27
EU Approvals 2025–26
Colistimethate 1 and 2 MIU — UK, Germany
Omeprazole 40 mg — UK, Hungary
Caspofungin 50 and 70 mg — Germany
Clarithromycin 500 mg — UK
Key Expected Approvals
Teicoplanin 200/400 mg — Italy, Portugal, France, Spain, Germany
Vancomycin 500/1000 mg — 16 EU Countries
Liposomal Amphotericin B — South Africa, Turkey, Brazil
6 Products Saudi Arabia — Site inspection Q1 FY2627
OUR ACCREDITATIONS
Trusted by 31 Regulatory Authorities
Approvals and certifications from leading global regulatory bodies across five continents.
WHO GMP INDIA
EU GMP HUNGARY
HEALTH CANADA
SAHPRA SOUTH AFRICA
MHRA UK
TGA AUSTRALIA
GMP RUSSIA
FDA THAILAND
NPRA MALAYSIA
DAV VIETNAM
FDA PHILIPPINES
ANVISA BRAZIL
SMCA LITHUANIA
INVIMA COLOMBIA
DR CONGO
MOH ECUADOR
TFDA TANZANIA
NAFDAC NIGERIA
PPB KENYA
NDA UGANDA
NMRA SRI LANKA
MOH CAMBODIA
FDA MYANMAR
DDA NEPAL
GLOBAL FOOTPRINT
50+ Countries. One Mission.
From regulated European markets to high-growth emerging regions, Gufic delivers trusted sterile injectables worldwide.
REGIONAL OPERATIONS
Structured Presence Across Every Region
A combination of direct market access, strategic partnerships, and localised regulatory approaches across all major global regions.
Regulated Markets (EU/SRA)
Driving Direct Market Access and Regulatory Leadership. Leadership in critical care injectables across select EU markets with a strong portfolio. EU-GMP certified facilities in Navsari and Indore ensuring scalable, compliant supply.
Canada and South Africa
Expanding High-Value Regulated Market Presence. Established registrations with significant business volumes in both markets. Ongoing registrations for key injectable products to expand portfolio and build a sustainable long-term presence.
MENA and CIS
Building Strategic Presence Across Middle East, North Africa and CIS. Filed 10+ dossiers in Saudi Arabia (SFDA) through strategic partners. Active presence in Morocco, Algeria, UAE, Syria, Iraq, Russia, and Uzbekistan.
APAC and Africa
Expanding Healthcare Access Across Emerging Markets. Present across Sri Lanka, Myanmar, Thailand, Malaysia, Philippines, Vietnam, Kenya, Uganda, Ethiopia, Tanzania, Nigeria, and French West Africa. Regional offices in Burundi and the Philippines strengthen local engagement and distribution efficiency.
Latin America
Strengthening Presence Across Key Growth Markets. Strong presence across Brazil, Mexico, Colombia, Peru, Chile, and Central America. Facilities approved by ANVISA, COFEPRIS, and DIGEMID enabling seamless market access and supply continuity.
R&D PIPELINE
150+ Products. Multiple Breakthroughs.
A robust development pipeline spanning critical care, oncology, gynaecology, neurology, and pain management
| Therapy Area | Product | Highlight |
|---|---|---|
| Critical Care | Dalbavancin | 2nd-gen antibiotic with weekly dosing, recently launched |
| Critical Care | Omadacycline Tosylate | 20-year patent secured until 2041 |
| Oncology | Selvax Immunotherapy | Pre-clinical success in pancreatic cancer |
| Gynaecology | Thymosin Alpha-1 | Phase 3 trials for Endometriosis successfully concluded |
| Neurology | Zarbot | First Indian botulinum toxin for neurological disorders |
| Pain Management | Once-a-week Injectable | Novel molecule with patent extending to 2031 |
STRATEGIC PARTNERSHIPS
Growing Through Global Alliances
From manufacturing collaborations to market entry partnerships, Gufic's License and Innovate model drives global reach.
Spectropharma, Saudi Arabia
Market entry and distribution for GCC
Prime Bio, USA
Indigenous Botulinum Toxin manufacturing.
Technoflex, France
Dual-chamber bag technology.
Selvax, Australia
Oncology immunotherapy.