World-Class Manufacturing Plant
Engineered for precision, purity, and high-volume pharmaceutical production under Schedule M and WHO-GMP guidelines.
Designed for cGMP Excellence & Contamination Control
Located in the industrial corridor of Makkerwali, Tehsil Nahan, Distt. Sirmour, Himachal Pradesh, KDR Pharma operates an integrated oral solid and liquid dosage manufacturing plant.
The facility incorporates unidirectional material and personnel flow patterns, cGMP cleanrooms with epoxy resin floor coatings, seamless coved joints, and SS 316L contact surfaces to guarantee 100% batch purity.
Tablets (Coated & Uncoated), Hard Gelatin Capsules, and Unit-Dose Oral Sachets.
Syrups, Suspensions, Cough Expectorants & Pediatric Dry Oral Suspensions.
AUTOMATED TABLET COMPRESSION & PACKAGING
Continuous In-Line Process Controls
Cleanroom Area Classifications
Our processing areas are categorized according to revised Schedule M and ISO 14644 cleanroom standards.
3.3 Area Classification Summary
Differential pressure and filtration specifications enforced across production, testing, and storage zones.
| Facility Area | Cleanroom Classification | Air Quality Standard |
|---|---|---|
| Dispensing & Sampling Booths | Grade A / ISO Class 5 Equivalent | Unidirectional Laminar Airflow (LAF) |
| Production Cleanrooms (Granulation, Compression, Coating) | Grade D / ISO Class 8 Equivalent | Positive Pressure Differential (5–15 Pa) |
| Quality Control Laboratory | Grade D / ISO Class 8 Equivalent | Controlled Temperature & Humidity |
| Microbiology Testing Laboratory | Grade C / ISO Class 7 Equivalent | HEPA Filtered Sterility Testing Zone |
| Warehouse Stores & Personnel Change Rooms | Controlled Area | Filtered Ambient Environment |
Air Handling & Environmental Specifications
Temperature
NMT 25°C
Continuous Monitoring
Relative Humidity
NMT 55%
Dehumidified Processing
Differential Pressure
5–15 Pa
Positive Cascade
Air Changes
20–25 / hr
Fresh Air Circulation
Filtration
EU4 + EU7 + HEPA
EU13 Terminal HEPA
Installed Production Equipment List
High-speed automated machinery with valid Design (DQ), Installation (IQ), Operational (OQ), and Performance Qualification (PQ).
Section 5. Major Equipment List
Calibrated and validated equipment installed across Granulation, Compression, Coating, Capsule Filling & Packaging lines.
| Equipment Name | Operation / Function | Capacity / Spec | Qty | Identification No. |
|---|---|---|---|---|
| Sampling Booth API & Excipients | Raw Material Sampling | Grade A / ISO 5 | 1 | KDR-DIS-01 |
| Dispensing Booth API & Excipients | Raw Material Dispensing | Grade A / ISO 5 | 1 | KDR-DIS-02 |
| Rapid Mixer Granulator (RMG) | Wet Granulation & Blending | 60 kg | 1 | KDR-RMG-01 |
| Fluid Bed Dryer (FBD) | Drying Granules | 60 kg | 1 | KDR-FBD-01 |
| Octagonal Blender | Lubrication & Final Blending | 300 L | 1 | KDR-OBL-01 |
| Rotary Tablet Compression Machine | Tablet Compression | 27 Station | 1 | KDR-CCM-01 |
| Auto Coater Machine | Film / Enteric Tablet Coating | 24/30" Pan Size | 1 | KDR-GAC-01 |
| Automatic Capsule Filling Machine | Hard Gelatin Capsule Filling | 25 T | 1 | KDR-CFM-01 |
| High-Speed Strip Packing Machine | Foil Strip Packaging | 47,000 Tabs/hr | 1 | KDR-STP-01 |
| Blister Packing Machines (2 Lines) | Alu-Alu & Alu-PVC Blister Line | 30,000–40,000 Tabs/hr | 2 | KDR-BLP-01 / 02 |
| Automatic Sachet Packing Machine | Unit Dose Sachet Filling | 30–50 Sachets/min | 1 | KDR-SPM-01 |
8. Purified Water Generation & Loop System
RO + DM based system engineered by ONUS Solutions with SS 316L distribution loop, UV disinfection system, and continuous TOC/conductivity monitoring.
- Daily Conductivity & pH Testing
- Weekly Microbial & TOC Analysis
- Sanitization loop with ozone & thermal circulation
5.1 Plant Utilities Infrastructure
Uninterrupted power grid support and clean compressed air systems supporting continuous round-the-clock commercial manufacturing operations.
- Oil-free Compressed Air System (Indo Air)
- Heavy-Duty DG Backup Generator (Sudhir Power)
- On-site Effluent Treatment Plant (ETP) for waste management