Drug Manufacturing License in India — Pharmaceutical & Ayurvedic Formulations
A drug manufacturing license is issued by the State Licensing Authority under the Drugs and Cosmetics Act, 1940, authorizing a facility to manufacture pharmaceutical formulations (allopathic tablets, capsules, syrups, injectables), Ayurvedic/Unani/Siddha (AUS) medicines, or homeopathic preparations. Manufacturing without a valid license is a severe criminal offense. DK Reg Compliance conducts pre-inspection Schedule M (GMP) gap audits, prepares Site Master Files, and handles Form 25 (Own Manufacturing) or Form 25A (Loan License) submissions.
- Pharmaceutical production units manufacturing allopathic tablets, capsules, syrups, or topicals
- Sterile formulation plants manufacturing parenteral injectables, eye drops, and IV fluids
- Contract manufacturing and pharma marketing brands applying for Form 25A Loan Licenses
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Overview & Local Scope
Fast-Track Drug Manufacturing License in India | Pharma & Ayurvedic in Karnataka
A drug manufacturing license is issued by the State Licensing Authority under the Drugs and Cosmetics Act, 1940, authorizing a facility to manufacture pharmaceutical formulations (allopathic tablets, capsules, syrups, injectables), Ayurvedic/Unani/Siddha (AUS) medicines, or homeopathic preparations. Manufacturing without a valid license is a severe criminal offense. DK Reg Compliance conducts pre-inspection Schedule M (GMP) gap audits, prepares Site Master Files, and handles Form 25 (Own Manufacturing) or Form 25A (Loan License) submissions.
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Contact UsPharmaceutical production units manufacturing allopathic tablets, capsules, syrups, or topicals
Sterile formulation plants manufacturing parenteral injectables, eye drops, and IV fluids
Contract manufacturing and pharma marketing brands applying for Form 25A Loan Licenses
Ayurvedic, Unani, and Siddha (AUS) manufacturers producing herbal or traditional formulations
Repacking and relabeling units handling bulk drug packaging under Form 25B
Step-by-step process
How our Karnataka registration works
GMP (Schedule M) Pre-Inspection Audit: We evaluate cleanroom infrastructure, water systems (WFI/purified), HVAC air handling, and QC laboratory readiness.
Technical Documentation Review: We prepare the Site Master File (SMF), manufacturing formulae, SOPs, and analytical validation reports.
Form 25 / Form 25A Application Compilation: We draft complete dossiers covering equipment lists, calibration records, and Technical Director/QA qualifications.
Portal Filing & Fee Challan: We upload the technical dossier on the state FDA portal and track joint SLA/CDSCO inspection scheduling.
Joint Inspection Defense & License Issuance: We accompany your technical team during physical facility audits and clear compliance queries until manufacturing license grant.
Documents required
Filing checklist for Karnataka
- Site Master File (SMF) describing factory layout, cleanrooms, HVAC, and water treatment systems
- Schedule M GMP compliance blueprint, environmental monitoring logs, and machinery list
- Qualified Technical Director and Quality Assurance/Quality Control head educational certificates + approval letters
- Product-specific manufacturing formulae, step-by-step procedures, and raw material specifications
- Analytical method validation reports and stability testing data for new formulations
- Factory building blueprint approved by municipal corporation / industrial development authority
- Factory license, pollution control board (PCB) consent to establish/operate, and fire safety certificate
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