Pharmaceutical Formulation Unit For Sale In Ankleshwar
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The facility is designed to manufacture pharmaceutical formulations with considerable scope for expansion and flexibility. They manufacture Anti-Inflammatory, Muscle Relaxants, Anti- Analgesics, Hormones & Steroids, Anthelmintic, Antibacterial & Antifungals, Antibiotics, Antivirals, Anti-Hypertensive, Antihistaminic, and Proton Pump Inhibitors.
Clientele type
They have domestic as well as international clients, they export to Portugal, Belarus, Sri Lanka, Kuwait, Kazakhstan, Philippines, India, papa-new-guinea, Yemen, and Timor-Leste to name a few.
Premises
OWNED
Premise Size: 55,000 sq.ft.
Market Value (in INR): 15.00 Cr
The manufacturing operations are carried out in a site, that has constructed areas divided into two floors (G+1). The construction occupies 14,000 sq. ft. ground floor and 13,000 sq. ft. first floor.
The ground floor is dedicated to manufacturing and storage activities, a dedicated AHU has been provided for each area.
The first floor is dedicated to Administrative and Quality units.
The air handling systems for the production block are located in the service area. Purified water systems are located on the first floor.
Asking Price Includes
Complete Manufacturing Infrastructure
Reason
The promoters are selling the business as they are moving abroad.
Other Details
The facility has a block with a modular design with unidirectional flow of the material.
The construction of the building is a duly R.C.C structure, and the floor in production/warehouse and QC/QA areas is covered with epoxy coating and coving.
All areas are designated to prevent possible mix-ups and to facilitate an orderly flow of men and materials.
The interior design of each module allows adequate space for operations within their specifically defined areas.
Dedicated sampling and dispensing booths for active materials and excipients are installed to avoid cross-contamination.
The manufacturing unit has licenses Form 25 and 28 issued by the Joint Commissioner of Food & Drug Control Administration, Gandhinagar, Gujarat State (India) for the manufacturing of oral solid dosage forms, i.e., general tablets and general capsules.
Quality Policy:
- To ensure that every product is manufactured and distributed with consistent quality, efficacy, and safety according to current GMP standards.
- To achieve excellence in products, processes, and systems through the team effort of trained personnel.
- To provide the best quality products to patients by following cGMP practices at every level of manufacturing as per the latest international guidelines and continuous improvements.
Tablet Section:
- Uncoated tablet
- Enteric-coated tablet
- Film-coated tablet
- Delayed release tablet
- Sustained release tablet
Capsule Section:
- Hard gelatin capsules (Pellets)
- Hard gelatin capsules (Powder)
The following manufacturing technologies are employed for tablets and capsules:
- Granulation (Sifter, Rapid Mixer Granulator, Fluid Bed Dryer, Multi Mill, Octagonal Blender)
- Compression Machine (27 & 35 station double rotary)
- Auto Coater 36’’
- Tablet/Capsule Inspection Machine & Metal Detector
- Capsule (Sifter, Cone Blender, Automatic Capsule Filling Machine)
- Packing (Blister Pack Machine, Strip Pack Machine, Alu-Alu Blister Pack Machine)
- Clean in Place (CIP) Technology for Cleaning of Equipment
Major Production Equipment:
- Rapid Mixture Granulator: Capacity: 150 Ltrs
- Fluidized Bed Dryer: Capacity: 60 Kg
- Octagonal Blender: Capacity: 300 Ltrs
- Tablet Compression Machine: 27 & 35 Station double rotary, capacity 75K to 1 Lac per Hour
- Auto Coater: Capacity: 50 to 70 kg
- Double Cone Blender: Capacity: 300 Ltrs
- Capsule Filling & Polishing Machine: Capacity: 25,000 capsules/hr
- Blister Packing Machine: Capacity: 1.5 Lac packs per day
- Strip Packing Machine: Capacity: 1 Lac packs per day
- Alu-Alu Blister Packing Machine: Capacity: 20K packs per day
Quality Control Lab Equipment:
- High-Performance Liquid Chromatography
- Dissolution Test Apparatus
- UV-VIS Spectrophotometer
- Fourier Transform Infrared Spectrophotometer
- Karl Fischer Titrator
- Potentiometric Titrator
- Analytical Balance
- Stability Chamber
- Laminar Air Flow Unit
Attributes of Premises:
- Good Housekeeping Practices
- Environmental Monitoring
- Health and Industrial Hygiene Practices
- Refreshment Facility
- Entry-Exit Procedure
- Quality and Production Area Dedicated
Major Utility Equipment:
- Gas Fired Steam Boiler 200kg/hr
- DG Set 200 KVA
- Distribution Transformer 630 KVA
- Water Generation Storage and Distribution System 1000 litre/hr
- Water Cooler x2: 150 Litres & 120 Litres
- Rotary Screw Compressor Air System 178 CFM
Brief Description of Heating, Ventilation, and Air-Conditioning (HVAC) System:
- Total Air Handling Units: 34
- AHU with Condenser: 23
- Fresh Air Units: 5
- Exhaust Air Units: 5
- Ductable Unit: 1
The core processing areas are designed as per Class ISO 8, and the microbiology lab is designed as per Class ISO 8 (at rest). The manufacturing rooms are maintained at a negative pressure in relation to adjacent passages. The HVAC system has 4 stages of filtration:
1. 10 micron HDPE filters placed at each return duct riser in the room.
2. 5 Micron HDPE filter placed in the mixing chamber on the return side of the AHU.
3. 3 Micron HDPE filter placed in the supply chamber on the supply side of the AHU.
4. 0.3 Micron HEPA filters.
Manufacturing Area:
- The manufacturing processing area has (ISO 8) Class 100,000 environment.
- cGMP design to avoid cross-contamination.
- Cleaning validations to ensure no carry-over residue.
- Dedicated Sampling and Dispensing Booth for API and Excipients.
Quality Control Functions:
- Qualifications/Calibration of QC instruments
- Working/Reference Standards Management
- Sampling Analysis & Reporting Results for Raw Materials & Packing Materials
- Receipt, Analysis & Reporting Results of In-Process & Finished Product Samples
- Stability Management
- Control Sample Management
- Resolving OOS, OOT
- Validation of Analytical Methods and Analysts
- Compliance with Good Laboratory Practices
- Initiation & Approval of Standard Operating Procedures
- Coordination and Approvals of Validations & Qualifications Protocols and Reports
- cGMP Compliance
- Line Clearance & In-Process Quality Assurance
- Artwork Approval
- Finished Product Release
- On-Job & Calendar Trainings
- Vendor Qualifications and Approval
- Annual Product Quality Review
Quality Management System:
- Change Control Management
- Deviation Control and Management
- Failure Investigation
- CAPA
- Handling of Market Complaints
- Handling of Recall
- Self-inspection
- Quality Risk Management
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