Drugs Manufacturing License

Experience a seamless, hassle-free & timely registration with our expert consultants.

✔Our in-house team handles over 50 types of business licenses.
✔We provide end-to-end services across India.
✔Ensuring smooth and continuous adherence to all legal requirements.

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Benefits of Drugs Manufacturing License

✔Legal Authorization to Manufacture Drugs and Pharmaceuticals
✔Brand Credibility Among Healthcare Professionals and Consumers
✔Eligibility for Government and Institutional Tenders
✔Market Expansion Through Retail and Wholesale Pharma Channels
✔Avoidance of Regulatory Penalties and Product Seizures

Applicability

Drugs Manufacturing License is required for:

✔Pharmaceutical companies setting up manufacturing units
✔Existing manufacturers seeking license expansion or renewal
✔Companies planning to manufacture generic or branded drugs
✔Entities producing Ayurvedic, Homeopathic, or Allopathic medicines
✔Manufacturers seeking to export pharmaceutical products

Licensing Process

Initial Consultation & Category Identification

Determining your product type and appropriate license form (25, 28, etc.).

Document Compilation & Verification

Assisting in preparation of technical documents and staff compliance.

Application Filing

Submission of application with the State/Central Licensing Authority.

Inspection & Verification

Coordination with Drug Inspectors for facility inspection and staff interviews.

License Approval & Grant

Issuance of the license post successful inspection and documentation.

Documents Required

✔Company Incorporation Certificate / Partnership Deed
✔Manufacturing Premises Address Proof and Rent/Lease Agreement
✔Site Layout Plan and Plant Design
✔Details of Manufacturing Equipment and Machinery
✔List of Technical Staff with Qualifications and Experience Certificates
✔Proof of Qualification and Registration of Competent Technical Staff (CTO)
✔Affidavit of Non-Conviction under Drugs Act
✔Environmental Clearance and Pollution NOC (if applicable)
✔GMP (Good Manufacturing Practices) Compliance Details
✔Product List and Formulation Details

Frequently Asked Questions

Common questions about Drugs Manufacturing License

A Drugs Manufacturing License is issued under the Drugs and Cosmetics Act, 1940, authorizing a facility to manufacture pharmaceutical drugs, formulations, or active pharmaceutical ingredients (APIs) in India.

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Rajesh Sharma

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Founder, RS Enterprises

“Bizotic Supervision Private Limited made our GST registration process incredibly smooth. Their team handled everything from documentation to filing, saving us weeks of effort. Highly recommended for any startup!”

Priya Mehta

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Director, Mehta Foods Pvt. Ltd.

“We needed FSSAI licensing urgently and Bizotic Supervision Private Limited delivered within the promised timeline. Their expertise in food business compliance is exceptional. Our go-to partner for all registrations.”

Amit Gupta

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CEO, Gupta Trading Co.

“From company incorporation to annual ITR filing, Bizotic Supervision Private Limited has been our trusted partner for 3 years. Their pricing is transparent and service quality is consistently excellent.”