Pharmaceutical Manufacturing Plant

🏭 Pharmaceutical Manufacturing Plant Setup

Setting up a pharmaceutical manufacturing plant requires precise planning, infrastructure, compliance with regulatory norms, and a clear understanding of market demands. We offer end-to-end guidance for establishing plants for Liquid Orals, Tablets, Capsules, Eye/Ear Drops, and Injectables.

🧪 Types of Formulations Covered:

• Tablets
  
  

• Capsules
  
  

• Liquid Syrups/Suspensions
  
  

• Eye/Ear/Nasal Drops
  
  

• Injectable (Dry & Liquid)
  
  

📊 Capacity-wise Project Cost Estimate

• Production Capacity                   Estimated Area Required                  Estimated Project Cost (INR)            Suitable for

• 10,000 Units/Day                           3,000 – 5,000 sq. ft.                             ₹1.5 – ₹2.5 Crores                               Small-scale/Startups

• 50,000 Units/Day                           7,000 – 10,000 sq. ft.                           ₹4 – ₹6 Crores                                      Mid-scale Units

• 100,000 Units/Day                         12,000 – 20,000 sq. ft.                         ₹8 – ₹12 Crores                                    Large-scale Plants

• 200,000 Units/Day                         25,000+ sq. ft.                                      ₹15+ Crores                                          Export-oriented/Contract                                                                                                                                                                         Manufacturing

💡 The cost includes civil work, HVAC, water systems, cleanroom setup, plant machinery, and validation costs.

🛠️ Machinery & Equipment (Section-wise)

1. Tablets Section

• Compression Machine
  
  

• Coating Machine
  
  

• Granulator
  
  

• Blender
  
  

• Tablet Press
  
  

• Dust Extractor
  
  

2. Capsules Section

• Capsule Filling Machine
  
  

• Capsule Polisher
  
  

• Capsule Inspection Belt
  
  

3. Liquid Oral Section

• Syrup Manufacturing Tank
  
  

• Liquid Filling Line
  
  

• Cap Sealing Machine
  
  

• Bottle Washing Machine
  
  

• Labeling Machine
  
  

4. Eye/Ear Drops Section

• Sterile Manufacturing Vessels
  
  

• Drop Filling Machine (ASEPTIC)
  
  

• Autoclave
  
  

• Air Handling Unit (AHU)
  
  

5. Injectable Section

• Vial Washing Machine
  
  

• Sterilization Tunnel
  
  

• Filling & Sealing Machine
  
  

• Laminar Airflow Unit
  
  

• Water for Injection (WFI) System
  
  

• Clean Room Equipment
  
  

📍 Area Requirement Breakdown

      Section                                                                           Minimum Area Requirement

• General Manufacturing                                                    1,000 – 5,000 sq. ft.

• Liquid Section                                                                   800 – 2,000 sq. ft.

• Tablets/Capsules                                                               2,000 – 5,000 sq. ft.

• Injectable Section                                                             3,000 – 10,000 sq. ft.

• Drops Section                                                                   500 – 1,200 sq. ft.

• QC & Micro Labs                                                               800 – 1,500 sq. ft.

• Warehouse & Storage                                                       2,000+ sq. ft.

• Admin/Utilities                                                                   1,000+ sq. ft.

🧾 Required Licenses & Approvals

Setting up a pharmaceutical manufacturing plant in India or abroad requires several mandatory approvals and licenses:

1. Drug Manufacturing License (Form 25 & 28) – from State Drug Control Authority.
   
   

2. Good Manufacturing Practices (GMP) Certification – Schedule M compliance.
   
   

3. WHO-GMP Certification (if required for export).
   
   

4. Pollution Control Board Clearance.
   
   

5. Factory License.
   
   

6. Fire & Safety Clearance.
   
   

7. NOC from Municipal Authorities.
   
   

8. FSSAI License (if applicable for neutraceuticals).
   
   

9. Environmental Clearance – especially for effluent generation.
   
   

10. Central Drugs Standard Control Organization (CDSCO) Registration (for injectables or large-scale plants).
    
    

11. ISO Certification (optional but beneficial for credibility).
    
    

📌 Key Highlights

✅ Custom-built facility design & layout
✅ HVAC & Water systems as per cGMP
✅ Utility planning (compressors, boilers, chillers)
✅ SOP & QA/QC documentation support
✅ Compliance consulting (WHO, USFDA, EU GMP readiness)

📞 Ready to Start?

Our experts can guide you through every step — from feasibility to licensing to plant commissioning. Get in touch to receive a customized project plan & quote based on your requirements.