Drug Manufacturing License in India — Pharmaceutical & Ayurvedic Formulations
Get your drug manufacturing license for tablets, capsules, injectables, or Ayurvedic formulations. DK Reg Compliance handles GMP compliance, Form 25 filing, and state FDA coordination.
- Businesses operating or planning to open in India
- Entities needing fast-track regulatory approval without delay
- First-time applicants requiring complete documentation guidance
Connect with our senior regulatory experts in 15 mins.
Overview & Local Scope
Fast-Track Drug Manufacturing License in India in India
Get your drug manufacturing license for tablets, capsules, injectables, or Ayurvedic formulations. DK Reg Compliance handles GMP compliance, Form 25 filing, and state FDA coordination.
Need help with your application in India?
Our local experts are ready to guide you through the process.
Businesses operating or planning to open in India
Entities needing fast-track regulatory approval without delay
First-time applicants requiring complete documentation guidance
What Is a Drug Manufacturing License?
A drug manufacturing license is issued by the State Licensing Authority under the Drugs and Cosmetics Act, 1940, authorizing a facility to manufacture pharmaceutical products. It is mandatory for any company producing allopathic drugs (tablets, capsules, syrups, injectables, topicals), Ayurvedic/Unani/Siddha (AUS) medicines, or homeopathic preparations. Manufacturing without a valid license is a criminal offense.
Types of Drug Manufacturing Licenses
- Form 25 (Non-Loan License) — Own manufacturing premises, own equipment
- Form 25A (Loan License) — Manufacturing at a third-party GMP-certified facility (contract manufacturing)
- Form 25B (Repacking License) — For repacking of bulk drugs
- AUS Manufacturing License — For Ayurvedic, Unani, and Siddha product manufacturers
GMP Compliance (Schedule M)
All drug manufacturing facilities must comply with Schedule M of the Drugs and Cosmetics Act, which mandates Good Manufacturing Practice (GMP) standards — including cleanroom infrastructure, water systems, HVAC, quality control laboratories, and qualified personnel.
DK Reg Compliance conducts a pre-inspection GMP gap analysis before filing, so your facility is inspection-ready.
Documents Required
- Site Master File (SMF) describing the facility, infrastructure, and quality systems
- Schedule M compliance documentation
- Qualified Person / Technical Director qualification and appointment letter
- Product-specific manufacturing formulae and procedures
- Equipment list and calibration records
- Stability data and analytical method validation (for new formulations)
- Water testing reports
- Constitution documents of the company
- State-prescribed application forms and fees
Loan License (Form 25A) — Contract Manufacturing
A loan license allows brands and marketers to manufacture products through a contract manufacturer (lender) without owning a factory. DK Reg coordinates both the lender’s compliance and the loan license applicant’s documentation, ensuring both parties are aligned before submission.
Step-by-step process
How our India registration works
Assess your business model and India regulatory classification.
Prepare and verify applicant documents and premises layout.
Submit application to the state/zonal authority covering India and track queries.
Receive final license delivery with ongoing compliance alerts.
Documents required
Filing checklist for India
- Identity and address proof of the applicant/directors
- Premises ownership or valid rental agreement in India
- Layout plan and site dimensions of the facility
- Business constitution documents (COI/Partnership Deed)
- Affidavits and declarations as required by India authority
Verified Support in India
Whether you are located in the business center of India or surrounding industrial corridors, our consultants manage state and zonal submissions directly.
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