Pharmaceutical Formulation Unit For Sale In Ankleshwar

Product / Service

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, Antihelminthic, 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): 150,000,000

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 duly R.C.C structure and the floor in production/warehouse & QC/QA area is covered with epoxy coating and coving.
All the 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 the conducting of operations within their specifically defined areas.
The dedicated sampling and dispensing booth for active materials and excipients are installed to avoid cross-contamination.

The manufacturing unit has licenses Form 25 & 28 issued by the Joint Commissioner of Food & Drug Control Administration, Gandhinagar, Gujarat State (India) for manufacturing of oral solid dosage form i.e. General Tablets and General Capsules.

QUALITY POLICY:
- To ensure that every product manufactured & distributed with consistent quality, efficacy & safety with present standards as per current GMP standards.
- To achieve excellence in products, processes, and systems through the team effort of trained personnel of the company.
- To provide the best quality products to patients by following cGMP practice 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 the manufacturing of 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 Equipments

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: 25000 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 Infra Red Spectrophotometer
- Karl Fischer Titrator
- Potentiometric Titrator
- Analytical Balance
- Stability Chamber
- Laminar Air Flow unit

ATTRIBUTES OF PREMISES:
- Good House Keeping Practices
- Environmental Monitoring
- Health and Industrial hygiene practices
- Refreshment Facility
- Entry-Exit Procedure
- Quality and production area dedicated

MAJOR UTILITY EQUIPMENTS:
- Gas Fired Steam Boiler 200kg/hr
- D G Set 200 KVA
- Distribution Transformer 630KVA
- 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 Unit: 34
- AHU with Condenser: 23
- Fresh Air Unit: 5
- Exhaust Air Unit: 5
- Ductable Unit: 1

The core processing areas are designed as per class ISO 8 and Microbiology lab is designed as per class ISO 8 (at rest). The manufacturing rooms are maintained at a negative pressure in relation to the 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 was 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 100000 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 instrument
- 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
- Co-ordination and approvals of Validations & Qualifications protocols and reports
- cGMP Compliances
- 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