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.
- Fast-track application drafting & authority liaisoning
- Guaranteed compliance with CDSCO/FSSAI/State guidelines
- 100% turnkey documentation support from start to approval
Connect with our senior regulatory experts in 15 mins.
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.
Need help with your application?
Our experts are ready to guide you through the process.
Other Services
Get your drug license for retail, wholesale, or manufacturing with DK Reg Compliance — India’s trusted drug license consultant. Expert guidance, fast approvals, pan-India service.
Get your wholesale drug license for pharmaceutical distribution — stockists, C&F agents, and distributors. DK Reg Compliance handles documentation, state FDA submissions, and approvals.
Open your pharmacy legally with a retail drug license. DK Reg Compliance handles Form 20 & 21 applications, pharmacist documentation, state FDA submissions, and fast approvals.
Expert CDSCO registration support for medical devices, drugs, IVDs, and cosmetics. DK Reg Compliance handles classification, SUGAM filing, and query responses — free assessment call.
Medical device registration in India — Class A, B, C, D classification, CDSCO filing, MD-14/MD-15 import licenses, and IVD registration. Expert support from DK Reg Compliance.
Get your medical device import license (MD-14/MD-15) from CDSCO. DK Reg Compliance prepares Device Master Files, Plant Master Files, and manages full SUGAM submission.
Find your question below or submit your inquiry for quick assistance.
Ready to proceed?