Drug License for Manufacturing

Company Formation Simplified

Drug License for Manufacturing

Ensuring Compliance in Drug Manufacturing and Distribution

About Drug License for Manufacturing

A drug license ensures that drugs are manufactured, distributed, and sold in compliance with regulatory standards. It guarantees that drugs are safe, effective, and of high quality, minimizing health risks to the public.

Types of About Drug License for Manufacturing

Manufacturing License

Issued to a person or company for manufacturing drugs for sale or distribution.

Wholesale License

Issued for wholesale activities including purchase, sale, distribution, and storage of drugs.

Retail License

Issued for retail sale of drugs directly to consumers.

Loan License

Allows manufacturing of drugs on behalf of another license holder.

Restricted License

Issued with specific restrictions on manufacturing or sale quantity.

Narcotics License

Required for manufacturing, selling, or distributing narcotic drugs.

Blood Bank License

Issued for establishing and operating a blood bank.

Cosmetics Manufacturing License

Required for manufacturing cosmetics containing drugs, such as creams and ointments.

Import License

Issued for importing drugs into India.

Check List

Application form
Proof of ownership or lease of manufacturing facility
Site plan and layout of the facility
List of equipment and machinery
List of drugs to be manufactured
Quality control measures plan
Details of technical staff
Consent letter from the premises owner (if leased)
No-objection certificate from the local municipal authority
Proof of payment of required fees

Required Documents

Documents needed for company registration

Application form
Ownership/Lease proof
Site plan
Equipment and machinery list
List of drugs
Quality control measures plan
Technical staff details
Consent letter (if leased)
No-objection certificate
Fee payment proof

Registration Process

Simple steps to register your Private Limited Company

1

Submit an application to the concerned regulatory authority with all required details and documents.

2

Verification of submitted documents by the authority.

3

Inspection of the manufacturing facility for compliance with standards.

4

Approval of the drug license upon successful inspection.

5

Issuance of the license, valid for a specified period, requiring periodic renewal.

Why Us?

Here’s why you should choose us!

We have extensive experience in business registration and compliance with the latest government regulations.
We provide excellent customer service and continuous support throughout the registration process.
Our services are cost-effective, offering competitive pricing without compromising quality.
We maintain transparency with a clear breakdown of services and fees.
We provide post-registration compliance support, ensuring clients avoid penalties and late fees.

Additional Benefits

Here’s why you should choose us!

Expert consultation and assistance
Regular updates and compliance tracking
Support for obtaining funding from banks and financial institutions

Available Across India

We provide company registration services across all major states.

Delhi

The applicant must submit an application to the Delhi Drugs Control Department along with required documents. Inspection will be conducted before approval.

Maharashtra

Applicants must apply to the Maharashtra FDA, ensuring compliance with GMP and providing all necessary documentation.

Advantages

Here’s why you should choose us!

Ensures legal compliance for drug manufacturing
Increases credibility and trust among consumers
Allows expansion of business operations
Ensures product safety and quality

post registration compliance

Good Manufacturing Practices (GMP)

Manufacturers must follow GMP to ensure product safety and efficacy.

Record Keeping

Proper records of raw materials, batch production, and testing must be maintained.

Quality Control

Implementation of quality control measures to ensure drug safety.

Adverse Event Reporting

Manufacturers must report any adverse reactions associated with their drugs.

License Renewal

Periodic renewal of the drug license is mandatory to continue operations legally.

Frequently Asked Questions

Find answers to common questions about our services

Still have questions?

Our team is here to help. Contact us for personalized assistance with your company registration needs.