About Megafine
Established in 1995, Megafine has grown into an innovation-driven manufacturer of APIs, Advanced Intermediates, as well as a trusted Contract Development and Manufacturing Organisation.
Megafine has two state-of-the-art manufacturing facilities. These facilities have been successfully inspected by leading global regulatory authorities, including the US FDA, EDQM, TGA, Health Canada, MFDS, PMDA, ANVISA, and COFEPRIS, among others.
For over three decades, we have partnered with leading global pharmaceutical companies, delivering compliant manufacturing, deep scientific capability, and scalable solutions.
Our operations are built on two focused and complementary divisions.
As a trusted API and Advanced Intermediates Manufacturer, we combine strong R&D expertise, backward integration, and end-to-end lifecycle management.
Megafine’s CDMO solutions are built on its proven capabilities in chemical process development and scalable manufacturing, enabling efficient execution from early development through commercial production.
Regulatory Approvals
Our Expertise
APIs
At Megafine, innovation drives everything we do. As a niche, R&D powered API specialist, we deliver strong IP support that helps customers launch early & lead their markets. Our global regulatory expertise proven through 250+ global regulatory fillings, 29 US DMFs, and 14 CEPs ensures unmatched quality, compliance, and confidence from development to delivery.
Advanced Intermediates
A trusted partner for advanced intermediates, offering comprehensive regulatory support for highly regulated markets.
CDMO
At Megafine, our CDMO services accelerate development programs for New Chemical Entities which enable a seamless transition from concept to commercial supply. Backed by an experienced scientific team, state-of-the-art infrastructure, regulatory compliant facilities, and advanced synthesis capabilities, we support projects from early development through commercial scale production. With dedicated project teams and rapid development and manufacturing support, we act as an extension of your laboratories, delivering customized, innovation led solutions aligned with your technical and regulatory requirements.
Capabilities & Infrastructure
Manufacturing
We operate two cGMP multipurpose manufacturing facilities in India at NASHIK, Maharashtra and VAPI, Gujarat. These facilities have a combined production capacity of 270 KL, including 17 production blocks, and 9 cleanrooms. A wide range of reactor types and sizes, enable batch sizes ranging from 1 kilogram to 500 kilograms, enabling seamless scalability from development to commercial production.
R&D
Our advanced R&D infrastructure forms the foundation of our innovation-driven approach to API and intermediate development. With a dedicated R&D centre at Nashik, we enable route scouting, rapid process development, optimization, and scalable manufacturing solutions aligned with global regulatory expectations.
At Megafine science drives our business.
IPM
Our Intellectual Property Management (IPM) framework integrates deep scientific understanding with strong legal and regulatory insight to protect innovation across the product lifecycle. Working closely with R&D, business teams and customers, our IPM specialists ensure that every development program is supported by a clear, defensible, and globally aligned patent strategy.
AR&D and Quality Control & Assurance
Our Analytical Research & Development (AR&D) function supports complete product lifecycle from early development to commercialization. Working in close collaboration with R&D, manufacturing & QC teams, AR&D ensures strong analytical understanding and robust control strategies to support consistent globally acceptable product quality.
CMO / CDMO
Our CMO/CDMO services provide end-to-end development and manufacturing support to global generic and innovator companies, covering the complete product lifecycle—from early-stage route scouting and process development to scale-up, commercial manufacturing, and regulatory submissions, including DMFs.
Kilo Plant
Equipped with SS, GLR, and Hastelloy reactors (1 to 10,000 L), hydrogenation capabilities, and solvent recovery systems, our H Block is purpose-built for complex chemistry and high-value manufacturing
Regulatory Approvals
Our manufacturing facilities comply with global regulatory and quality standards, having been inspected and approved by leading international regulatory authorities. These approvals reflect our strong commitment to cGMP compliance, robust quality systems, data integrity, and regulatory transparency.
With multiple globally recognized regulatory approvals and a pure play API company, we are a preferred partner for customers seeking to register and commercialize products in highly regulated global markets. We maintain a constant state of audit readiness and continuously align our systems and processes with evolving regulatory expectations to ensure reliable and compliant supply worldwide.
Powering Smarter Pharma
Global Reach in API Supply
We proudly serve clients in over 40 countries, exporting 98% of our output to regulated markets, including
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Whether it’s an innovator needing a trusted CDMO or a generics player seeking regulatory-ready APIs, Megafine is your go-to manufacturing partner.
Global Reach in API Supply
We proudly serve clients in over 60 countries, exporting 98% of our output to regulated markets, including
- Client Locations
- Client Locations
- Client Locations
- Client Locations
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