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WHO-GMP Certified Manufacturer

Precision Science.
Transforming Lives
Through Pharma.

Agarose Scientific is a next-generation pharmaceutical manufacturer delivering high-quality APIs, formulations, and research-backed drug solutions trusted by partners across the globe.

Certified By
WHO-GMP ISO 9001:2015 ISO 14001 USFDA
25+
Years of Pharmaceutical Excellence
500+
Drug Formulations Developed
60+
Countries Exported To
1200+
Research & Manufacturing Staff
What We Do

End-to-End Pharmaceutical
Manufacturing Solutions

From API synthesis to finished dosage forms — we manage the complete pharmaceutical value chain with precision and compliance.

API Manufacturing

Large-scale active pharmaceutical ingredient synthesis using cutting-edge chemical engineering and continuous manufacturing platforms.

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Formulation Development

Custom drug formulation across tablets, capsules, injectables, topicals and advanced delivery systems — from prototype to scale.

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Quality Control & Assurance

Rigorous multi-stage QC protocols, real-time analytics, and full regulatory documentation ensuring every batch meets global standards.

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R&D & Innovation

Dedicated research teams exploring novel drug molecules, delivery technologies and generics pipeline with a 42-patent portfolio.

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Regulatory Affairs

Expert regulatory strategy, dossier preparation, and global filing support for FDA, EMA, WHO-PQ, and local health authority submissions.

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Contract Manufacturing

CMO / CDMO services for global pharma brands — flexible capacity, GMP-compliant facilities, and end-to-end supply chain management.

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About Agarose Scientific

A Legacy Built on Science, Integrity & Innovation

Founded in 2000, Agarose Scientific has grown from a regional API manufacturer into a globally trusted pharmaceutical partner — with state-of-the-art facilities and an unwavering commitment to patient wellbeing.

Patient-Centric Approach

Every compound we develop starts and ends with the patient — quality, safety, and efficacy are non-negotiable.

Global Standards, Local Expertise

Operating under USFDA, EMA, and WHO guidelines while maintaining agile, responsive local operations.

Sustainable Manufacturing

Green chemistry principles, zero-waste initiatives, and ISO 14001 environmental management across all facilities.

Research & Innovation

Science That Drives Tomorrow's Medicines

🧬

Oncology Pipeline

Targeted therapies and oncological APIs with 12+ active compounds in late-stage development.

💊

Drug Delivery Systems

Nano-encapsulation, controlled-release, and transdermal patches for enhanced bioavailability.

🔬

Generics Development

Bioequivalence studies and ANDA filings enabling affordable global access to essential medicines.

🧪

Biologics & Biosimilars

Protein characterization, cell-line development, and biosimilar pathway expertise.

Our Leadership

Meet the Minds Behind
Agarose Scientific

👨‍🔬
Dr. Rajiv Mehta
CEO & Chairman
Ph.D. Pharmaceutical Sciences
👩‍⚕️
Dr. Priya Sharma
Chief Scientific Officer
Ph.D. Medicinal Chemistry
👨‍💼
Mr. Arjun Kapoor
Chief Operations Officer
MBA, Operations Management
👩‍🔬
Dr. Anjali Nair
Head of Research & QC
Ph.D. Biochemistry

Partner With a Pharmaceutical Leader

Whether you need contract manufacturing, R&D collaboration, or regulatory support — let's build something remarkable together.

Home / About Us
Our Story

Built on Science.
Driven by Purpose.

For over 25 years, Agarose Scientific has led pharmaceutical manufacturing with a singular mission: enabling better patient outcomes through precision science and responsible innovation.

Our Foundation

Mission, Vision & Values

🎯 Our Mission

To manufacture and deliver high-quality pharmaceutical products that improve human health — with unwavering commitment to safety, efficacy, and ethical responsibility.

🔭 Our Vision

To be the world's most trusted pharmaceutical manufacturing partner — pioneering innovations that make life-saving medicines accessible to every corner of the globe.

⭐ Our Values

Integrity in every process. Excellence in every product. Transparency with every partner. Sustainability in every decision. Innovation without compromise.

Our Journey

25 Years of Pharmaceutical Excellence

2000

Foundation & First Facility

Agarose Scientific was established in Ahmedabad with a state-of-the-art API manufacturing plant, beginning with 5 core pharmaceutical compounds.

2005

First International Certification

Achieved WHO-GMP certification and commenced export operations to Southeast Asia and African markets — a pivotal milestone in global expansion.

2010

R&D Center Launch

Inaugurated a dedicated 50,000 sq ft Research & Development Centre with over 150 scientists focused on novel formulations and generics pipeline.

2016

USFDA Approval & US Market Entry

Received USFDA approval for our injectable manufacturing facility, enabling entry into the highly regulated US pharmaceutical market.

2020

Biosimilar Division Established

Launched the Biologics & Biosimilars division, investing ₹500 crore in biopharmaceutical infrastructure to serve the next frontier of medicine.

2025

Global CMO Leader Recognition

Recognized as one of India's Top 10 Contract Manufacturing Organizations with 60+ export markets and 1,200+ employees worldwide.

Compliance & Certifications

Globally Recognized Quality Standards

Our manufacturing processes and quality systems are validated and certified by the world's most rigorous regulatory bodies.

🏆

WHO-GMP

World Health Organization Good Manufacturing Practice

✅

USFDA

United States Food & Drug Administration Approved

🇪🇺

EU-GMP / EMA

European Medicines Agency Compliance

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ISO 9001:2015

International Quality Management Systems

🌱

ISO 14001:2015

Environmental Management System Certified

⚕️

CDSCO

Central Drugs Standard Control Organisation

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ICH Guidelines

International Council for Harmonisation Compliant

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PIC/S GMP

Pharmaceutical Inspection Co-operation Scheme

Ready to Work Together?

Let's discuss how Agarose Scientific can support your pharmaceutical needs.

Home / Services
What We Offer

Full-Spectrum Pharma
Manufacturing Services

From molecule to market — Agarose Scientific offers a comprehensive portfolio of pharmaceutical manufacturing, research, and regulatory services tailored for global requirements.

API Manufacturing

World-class Active Pharmaceutical Ingredient manufacturing using cutting-edge chemistry platforms. Our multi-step synthesis capabilities cover a broad therapeutic spectrum.

Continuous manufacturing processes
Multi-kg to multi-ton production scale
Chiral synthesis & asymmetric catalysis
Hazardous chemistry capabilities (hydrogenation, ozonolysis)
Full ICH & WHO-GMP compliance

Formulation Development

State-of-the-art formulation R&D and commercial manufacturing across solid, liquid, and semi-solid dosage forms — built for global regulatory filing.

Tablets, capsules, and soft gels
Sterile injectables & lyophilization
Topicals, transdermals, and patches
Oral liquids & suspensions
Modified-release and enteric formulations

Quality Control & Assurance

Comprehensive QC laboratories equipped with advanced analytical instruments ensuring every product batch meets defined specifications.

HPLC, GC, LC-MS/MS analysis
Microbiological testing & environmental monitoring
Stability studies (ICH zones I–IV)
In-process quality checks & SOP adherence
Batch release and certificate of analysis

Regulatory Affairs & Dossier Preparation

Experienced regulatory teams navigating complex global submission requirements — reducing time-to-market and maximizing approval probability.

USFDA ANDA / NDA submissions
EMA marketing authorization applications
WHO prequalification support
CTD, ACTD dossier compilation
Post-approval change management

Contract Development & Manufacturing (CDMO)

Full-service CDMO solutions — we partner with innovator companies and generic manufacturers to bring their products from development to commercial scale.

Feasibility studies and tech transfer
Scale-up from lab to plant
Commercial manufacturing and packaging
Dedicated project management teams
Confidentiality and IP protection

Supply Chain & Logistics

End-to-end cold chain and ambient supply chain management ensuring pharmaceutical integrity from our facilities to patients worldwide.

Cold chain 2–8°C and -20°C management
GDP-compliant warehousing & distribution
Real-time track and trace systems
Export documentation and customs clearance
Global logistics network in 60+ countries
How We Work

Our Manufacturing Process

A structured, transparent workflow from client onboarding to final product delivery.

01

Discovery & Feasibility

Technical assessment, cost-benefit analysis, and development roadmap planning.

02

Development & Optimization

Lab-scale synthesis, formulation trials, and analytical method development.

03

Regulatory Filing

Dossier preparation, submission management, and regulatory liaison.

04

Scale-Up & Validation

Pilot batches, process validation, equipment qualification, and tech transfer.

05

Commercial Launch

GMP manufacturing, QC release, packaging, and supply chain deployment.

Need a Manufacturing Partner?

Our team is ready to discuss your specific pharmaceutical project requirements.

Home / Research & Innovation
Science at the Core

Research That
Shapes Medicine's Future

Our multidisciplinary research teams are at the frontier of pharmaceutical science — developing new molecules, improving existing therapies, and pioneering next-generation drug delivery.

All Areas Oncology Drug Delivery Generics Biologics
Key Focus Areas

Our Research Pillars

🧬

Oncology & Targeted Therapy

Developing targeted oncological APIs including kinase inhibitors, immune checkpoint modulators, and ADC payloads for precision cancer treatment.

12 Active Compounds
💊

Advanced Drug Delivery Systems

Nano-encapsulation, liposomal formulations, controlled-release matrices, and transdermal systems optimizing drug bioavailability and patient adherence.

8 Patents Filed
🧪

Generics & ANDA Development

Bioequivalence study design, formulation strategies for BCS Class II/IV molecules, and comprehensive ANDA filing with proven first-cycle approval rates.

120+ ANDAs Filed
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Biologics & Biosimilars

Cell line development, upstream/downstream bioprocessing, and comprehensive biosimilar comparability studies for monoclonal antibodies and fusion proteins.

5 Biosimilars in Pipeline
❤️

Cardiovascular & Metabolic

Novel antihypertensives, lipid-lowering agents, and diabetes treatments — addressing the world's leading causes of morbidity with new chemical entities.

3 NCEs in Phase II
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CNS & Neurological Disorders

Research into blood-brain barrier-penetrating molecules and innovative approaches to neurodegeneration, anxiety, and psychiatric conditions.

Early Discovery Phase
42+
Active Patents Held
350+
Research Scientists
120+
Publications & Papers
18+
Clinical Trial Collaborations
Publications

Recent Research Highlights

📄
Oncology | 2024

EGFR-Targeted Nano-Encapsulated Gefitinib for Non-Small Cell Lung Cancer: A Comparative Bioavailability Study

Demonstrated 3.2× improvement in bioavailability over conventional formulation using proprietary polymeric nanocarrier technology.

Sharma P., Mehta R., Nair A. et al. — Journal of Controlled Release, 2024
📄
Drug Delivery | 2023

Transdermal Delivery of Telmisartan via Self-Emulsifying Microemulsion: Optimization and In-Vivo Evaluation

Validated transdermal penetration achieving 87% bioavailability compared to 42% oral route, reducing dosing frequency to once-weekly.

Kapoor A., Verma S., Nair A. — International Journal of Pharmaceutics, 2023
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Biosimilars | 2023

Physicochemical and Functional Comparability of AS-Bevacizumab-01 to Reference Bevacizumab: A Comprehensive Biosimilar Assessment

Established analytical and functional similarity across 27 quality attributes supporting IND filing for the Company's lead mAb biosimilar.

Nair A., Sharma P. et al. — mAbs Journal, 2023
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Generics | 2022

Formulation Strategy for BCS Class IV Molecule Bedaquiline: Overcoming Solubility and Permeability Challenges

Successfully developed a bioequivalent generic formulation using hot-melt extrusion, enabling affordable TB treatment access in LMICs.

Mehta R., Iyer K., et al. — European Journal of Pharmaceutical Sciences, 2022

Collaborate With Our Research Team

We welcome academic, clinical, and industry partnerships to accelerate pharmaceutical innovation.

Home / Our Team
The Experts Behind the Science

Meet the People Who
Make It Happen

Our team of 1,200+ professionals — scientists, engineers, regulatory experts, and operational leaders — are united by a passion for advancing human health through pharmaceutical excellence.

Executive Leadership

Senior Leadership Team

👨‍🔬
Dr. Rajiv Mehta
Chief Executive Officer & Chairman
With 30+ years in pharmaceutical manufacturing, Dr. Mehta founded Agarose Scientific with a vision to make quality medicines globally accessible. He holds a Ph.D. in Pharmaceutical Sciences from IIT Bombay and an MBA from IIM Ahmedabad.
Ph.D. Pharma SciencesMBA IIM-A30+ Years
👩‍⚕️
Dr. Priya Sharma
Chief Scientific Officer
Dr. Sharma leads all R&D, formulation, and analytical functions. Her pioneering work in nanoparticle drug delivery has resulted in 18 patents. Previously a researcher at GSK and IISc Bangalore.
Ph.D. Medicinal Chemistry18 PatentsEx-GSK
👨‍💼
Mr. Arjun Kapoor
Chief Operations Officer
Arjun oversees manufacturing, supply chain, and plant operations across three facilities. Expert in lean manufacturing and Six Sigma, he has delivered 40% operational efficiency improvements since joining.
MBA OperationsSix Sigma BBLean Expert
👩‍🔬
Dr. Anjali Nair
Head of Quality & Compliance
Dr. Nair has led over 50 successful regulatory inspections including USFDA, WHO, and EU GMP audits. She holds a Ph.D. in Biochemistry and is a certified QP for the European market.
Ph.D. BiochemistryEU QP CertifiedFDA Expert
👨‍⚖️
Mr. Sanjay Iyer
VP – Regulatory Affairs
Sanjay has stewarded 200+ regulatory submissions across FDA, EMA, TGA, and WHO-PQ with an 88% first-cycle approval rate. He is a member of the Indian Drug Manufacturers' Association regulatory committee.
M.PharmRAC Certified200+ Submissions
👩‍💼
Ms. Ritu Desai
Chief Financial Officer
Ritu oversees all financial operations, strategic investments, and investor relations. Under her leadership, Agarose Scientific achieved a CAGR of 18% over the last decade and secured ₹500 crore in biosimilar investments.
CA (ICAI)CPAM.Com Finance
Department Heads

Scientific & Technical Leaders

🔬
Dr. Kiran Patel
Head, API Process Chemistry
Expert in green chemistry and continuous flow synthesis. Led scale-up of 80+ APIs from bench to commercial production.
Ph.D. Organic ChemistryIIT Madras
🧫
Dr. Meera Krishnan
Head, Biologics Division
Cell biology and upstream bioprocessing expert. Built the biologics infrastructure from scratch, filing 5 biosimilar INDs within 4 years.
Ph.D. Cell BiologyMIT Postdoc
🏭
Mr. Vivek Chandra
Plant Director – Sterile Manufacturing
20 years of sterile manufacturing expertise. Oversaw the design, commissioning, and USFDA approval of Agarose's injectable facility.
B.Tech Chemical Eng.Sterile Mfg Expert
Careers at Agarose Scientific

Join Our World-Class Team

We're always looking for passionate scientists, engineers, and professionals who want to make a meaningful difference in global healthcare.

Home / Contact Us
Get In Touch

Let's Start a Conversation

Whether you're looking for a manufacturing partner, exploring research collaboration, or have product inquiries — our team is ready to assist.

Send Us a Message

We typically respond within 24 business hours.

✅ Thank you! Your message has been sent. Our team will be in touch within 24 business hours.
🏭
Registered Office
Agarose Scientific Pvt. Ltd.
Plot No. 42, Pharma SEZ
GIDC Naroda, Ahmedabad – 382 330
Gujarat, India
📞
Phone & WhatsApp
+91 79 2234 5678 (Main)
+91 98765 43210 (WhatsApp)
Mon–Sat, 9:00 AM – 6:00 PM IST
📧
Email
General: info@agarosescientific.com
Business: bd@agarosescientific.com
Regulatory: ra@agarosescientific.com
🌐
International Offices
USA: 350 5th Ave, New York, NY 10118
Germany: Mainzer Landstraße 50, Frankfurt
Singapore: 1 Raffles Place, #20-61
FAQ

Frequently Asked Questions

What is the minimum order quantity for API manufacturing? +

Our minimum quantities vary by compound complexity. For standard APIs, MOQ starts at 5 kg (lab/development grade) and 100 kg (commercial grade). We accommodate smaller pilot quantities for R&D partnerships.

Do you offer contract manufacturing for third-party brands? +

Yes, we are a full-service CDMO. We offer end-to-end contract manufacturing including development, regulatory filing, scale-up, and commercial production under strict confidentiality agreements and NDA protection.

Which regulatory markets do your products comply with? +

Our facilities are approved by USFDA, EMA, WHO-GMP, TGA (Australia), and ANVISA (Brazil). We manufacture for markets across 60+ countries with facility-specific regulatory approvals.

How do I initiate a manufacturing partnership? +

Simply fill the contact form or email bd@agarosescientific.com. Our business development team will schedule a discovery call within 48 hours, followed by a feasibility assessment and formal proposal.