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Setting up a pharmaceutical manufacturing unit in India requires navigating complex licensing procedures and strict regulatory compliance. At Aone Consultant, we provide professional, end-to-end support for obtaining Pharmaceutical Manufacturing Licenses across Gujarat, with a strong focus on Vapi, Ankleshwar, Bharuch, Dahej, and nearby GIDC zones.
Whether you're starting a new pharma unit or expanding an existing one, our team helps you meet all legal, technical, and environmental requirements efficiently and compliantly.
What is a Pharmaceutical Manufacturing License?
What is a Pharmaceutical Manufacturing License?
A Pharmaceutical Manufacturing License is mandatory for companies involved in the production of medicines, drugs, or active pharmaceutical ingredients (API). It is issued under the Drugs and Cosmetics Act, 1940, and governed by Central Drugs Standard Control Organization (CDSCO) and State FDA authorities.
There are two primary types:
Form 25 – For manufacturing allopathic drugs.
Form 28 – For manufacturing drugs under a loan license model.
Our Consultancy Services Include:
✅ New License Application & Setup Guidance
Assistance in applying for Form 25/Form 28.
Preparation of documents, application forms, and affidavits.
✅ Layout & GMP Compliance
Guidance for Schedule M compliant plant layout.
Facility planning for production, quality control, and storage.
✅ Documentation & Technical File Support
Standard Operating Procedures (SOPs).
Equipment list, qualification documents, QA/QC protocols.
✅ Coordination with Authorities
Communication with State FDA, CDSCO, and Pollution Control Board.
Preparation for site inspection and audit.
✅ License Amendments, Renewals & Product Endorsement
Support for adding new products or expanding capacity.
Managing license renewals and ownership changes.
Why Choose Aone Consultant?
Based in Vapi, serving all major GIDC areas: Dahej, Ankleshwar, Bharuch, Saykha, Vilayat, Jhagadia, Daman
Proven expertise in handling drug regulatory documentation
Technical team with pharma background
Fast turnaround & inspection readiness
100% regulatory compliance focus
Environment & Safety Compliance Support
Environment & Safety Compliance Support
We also help ensure compliance with related regulatory requirements:
Consent from State Pollution Control Board (SPCB)
Fire NOC
Factory Act approvals
Hazardous material handling and worker safety certifications
Ready to Start Your Pharmaceutical Manufacturing Unit?
Ready to Start Your Pharmaceutical Manufacturing Unit?
Get in touch with Aone Consultant – Vapi’s trusted pharma licensing expert – and ensure your setup is legally compliant, operationally efficient, and future-ready.
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