India-based API manufacturer and CMO/CDMO partner, certified to EU GMP and WHO cGMP standards. Purpose-built for global regulated markets.
EU GMP Approved
European competent authority · 2025
WHO cGMP Certified
Current Good Manufacturing Practice
ISO 9001:2015
Quality management system certified
ESG Compliant
Solar powered · Approved ETP
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Years experience
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Export countries
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APIs total
Our credentials
Leadership with 25 years of pharma expertise
GPHC API was founded by promoters with over 25 years of experience in pharmaceutical manufacturing and international trade, with a proven track record of exporting to 40+ countries worldwide.
25+ years
Pharmaceutical manufacturing and international export experience behind our founding team.
40+ countries
Export destinations served by our promoters across regulated and emerging markets worldwide.
EU GMP 2025
Approved by European competent authority. Fully audit-ready for QP inspections.
ESG committed
Solar-powered facility with full environmental compliance and approved ETP.
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Years promoter experience
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Export countries
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Commercial APIs
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APIs in pipeline
CMO / CDMO
A key strength: contract API manufacturing
CMO/CDMO services are at the heart of what GPHC offers, covering everything from initial process development through to commercial GMP supply under our EU GMP approved facility.
Development
Process development
Route optimisation, impurity profiling, and scale-up from R&D through pilot to commercial.
Manufacturing
Commercial GMP supply
Full GMP batch manufacturing with CoA, batch records, and complete quality documentation.
Regulatory
CEP and DMF support
CEP applications (EDQM), DMF filings, and audit readiness for your target markets.
API portfolio
A growing product portfolio
Six established APIs for regulated markets, plus a pipeline of 10 high-value molecules across cardiovascular, gastroenterology, antifungal, and anaesthesia areas.
GPHC API was founded by promoters with over 25 years of experience in pharmaceutical manufacturing and international trade, delivering high-quality APIs to regulated markets worldwide.
Our origin
Built from the ground up, for global regulated markets
GPHC API was established at the SIPCOT Industrial Complex, Tiruvannamalai, Tamil Nadu, as a purpose-built, greenfield API manufacturing facility. We received our EU GMP approval in 2025 and have since commercialised a growing range of APIs to regulated markets worldwide.
Our promoters bring over 25 years of pharmaceutical manufacturing and export experience to GPHC. That depth of knowledge underpins every decision we make, from facility design through to quality systems and customer service.
Key milestones
2025
EU GMP approval received. Commercial operations commenced.
2025
WHO cGMP certification and ISO 9001:2015 achieved.
NOW
Growing product portfolio. 10 APIs in active development pipeline.
Sustainability and safety
Manufacturing responsibly and safely
At GPHC, responsible manufacturing is built into the fabric of how we operate. From clean energy to environmental compliance to worker safety, we hold ourselves to the highest standards.
Solar powered facility
Our entire facility runs on solar energy, significantly reducing our carbon footprint. We are committed to clean manufacturing as a long-term operating principle, not just a compliance exercise.
Effluent treatment
Our government-approved Effluent Treatment Plant (ETP) and dedicated Sewage Treatment Plant (STP) ensure that all process effluents and waste water are treated to regulatory standards before discharge.
Workplace safety
Safety is embedded in our day-to-day operations. Our facility follows strict GMP-compliant safety protocols, with clearly designated zones, trained staff, and regular safety audits to protect our people and our products.
CMO / CDMO Services
Your molecule. Our expertise. Your timeline.
GPHC has built a strong capability in contract API manufacturing. We work with generic pharma, innovators, and specialty pharma clients to develop and manufacture APIs under our EU GMP certified facility.
Why GPHC
What makes us a strong CMO/CDMO partner
Responsive
Direct access to our technical team. Feasibility responses within 5 to 7 working days.
Flexible
Pilot to commercial scale. Reactors from 1 KL to 10 KL, matched to your programme.
Compliant
EU GMP approved, WHO cGMP certified. Audit-ready every day, full documentation at all stages.
CEP support
We support CEP (EDQM) applications for clients, simplifying access to key regulated markets.
Our process
How we work with you
1
Feasibility review
We assess your synthetic route and chemistry fit and respond within 5 to 7 working days.
2
Process development
Route optimisation, impurity profiling, and process robustness in our independent R&D setup.
3
Pilot batches
Pilot scale batches with full analytical data and batch records before commercial scale-up.
4
Commercial GMP manufacturing
Validated GMP batches: batch record, CoA, ICH stability, and full regulatory package.
Our facility handles a wide range of synthetic reactions across most therapeutic areas. Not sure if your molecule fits? Contact us and we will respond promptly.
Antibacterial, cardiovascular, gastroenterology, antifungal, anaesthesia, diabetes, and most other therapeutic areas.
Regulatory
We support your market access
CEP applications
Certificate of Suitability (CEP) application support through EDQM, simplifying API registration in regulated markets.
DMF support
Drug Master File preparation and filing support for regulated market submissions.
Audit readiness
GMP certificates, full site documentation, and access for client QP qualification visits at any time.
Products
A growing API portfolio for global regulated markets
Established APIs for immediate supply, plus a pipeline of 10 high-value molecules in development. All products manufactured to relevant pharmacopoeial standards.
CEP application support available for all products.
Pipeline
APIs under development
10 high-value APIs in active development across cardiovascular, gastroenterology, antifungal, anaesthesia, and metabolic areas.
API
CAS No.
Therapeutic area
Target standards
Status
Prucalopride
179474-81-8
Gastroenterology
EP / USP
In development
Nicardipine
55985-32-5
Cardiovascular
EP / USP / JP
In development
Ketoconazole
65277-42-1
Antifungal
EP / USP
In development
Bisoprolol
66722-44-9
Cardiovascular
EP / BP / USP
In development
Apixaban
503612-47-3
Anticoagulant
EP / USP
In development
Rocuronium
119302-91-9
Anaesthesia
EP / USP
In development
Vecuronium
50700-72-6
Anaesthesia
EP / USP
In development
Vonoprazan
881681-00-1
Gastroenterology
JP / EP
In development
Vildagliptin
274901-16-5
Diabetes
EP / USP
In development
Itraconazole
84625-61-6
Antifungal
EP / USP / BP
In development
Contact us to discuss early-access supply agreements or CMO/CDMO partnerships for pipeline molecules.
Campaign products
Licensed APIs available for campaign manufacture
GPHC holds manufacturing licences for over 80 APIs across a wide range of therapeutic areas. These are available for campaign manufacture. Contact us to discuss your requirements.
Don’t see your API listed? Our licences and capabilities extend further. Contact us with your molecule and we will confirm availability promptly.
Capabilities
A greenfield API facility built for global regulated markets
GPHC operates from a purpose-built, greenfield API manufacturing facility at SIPCOT Industrial Complex, Tiruvannamalai. The facility was designed to EU GMP standards from the outset.
Facility
Purpose-built, audit-ready
Unlike retrofitted facilities, GPHC was constructed specifically for regulated-market API manufacturing, with purpose-designed material flows and quality infrastructure built in from the start.
Multi-scale reactors
Reactor capacities from 1 KL to 10 KL supporting development, pilot, and commercial batches within the same facility.
Glass-lined and SS reactors
Glass-lined reactors for corrosive chemistries and stainless steel for standard routes, giving flexibility across a wide range of syntheses.
Full downstream processing
Centrifuge, filtration, drying, and blending for complete API processing from reaction to finished bulk.
Solar powered
Facility powered by solar energy, reflecting our commitment to ESG and sustainable pharmaceutical manufacturing.
Air handling (AHU)
Controlled, filtered air supply to cleanrooms and manufacturing areas for consistent product quality.
Environmental compliance
Government-approved ETP and STP. Full environmental compliance built into our facility design.
Quality and compliance
EU GMP Approved. Audit-ready every day.
Our quality systems are built for continuous, reliable API manufacturing, not just for inspections. Every batch leaves with full documentation and the confidence of EU GMP certification.
Certifications
Our approvals
EU GMP
Approved
EU GMP Certificate of Compliance
Issuing authority: State Institute For Drug Control, Slovakia
Certificate No: SK/012V/2025
Inspection date: 4 May 2025
Issuance date: 22 July 2025
EudraGMDP ref key: 178496
Scope: Ofloxacin, Norfloxacin, Levofloxacin
Issued under Art. 111(5) of Directive 2001/83/EC. Verifiable on the EudraGMDP database.
WHO cGMP
WHO current Good Manufacturing Practice certification, a globally recognised standard accepted by regulatory authorities across all major markets.
CEP support available: We support Certificate of Suitability (CEP) applications through EDQM for our products and CMO/CDMO clients.
QC laboratory
Testing capabilities
HPLCGCFTIRUV-VisTOC analyserMicrobiological labICH stability21 CFR Part 11Validated methods
All critical instruments are 21 CFR Part 11 compliant. Stability studies conducted to ICH Q1A(R2). All methods validated prior to use in batch release.
QMS
Quality management
Change control and CAPA
Formal change control, deviation management, and CAPA tracking for all GMP activities.
ICH stability programme
Stability studies to ICH Q1A(R2) supporting shelf life claims and regulatory filings.
Annual product reviews
Annual reviews for all commercial APIs with quality trend analysis and process improvement.
Quality agreements
Quality Agreement framework available for all CMO/CDMO clients.
Enquire
Get in touch with our team
We welcome enquiries for API supply, CMO/CDMO partnerships, facility audits, CoA requests, and CEP support. Email us and we will respond within 2 working days.
Send us an email with your enquiry: a product quotation, a molecule for CMO/CDMO assessment, a Certificate of Analysis request, or a general question about our capabilities. Our team will respond within 2 working days.
