Manufacturing  

State-of-the-Art Manufacturing Facility                              

Location and Accessibility:

- Situated in a green, pollution-free zone

- Easily accessible, approximately 80km from Hyderabad International Airport via ring road

Facility Design and Construction:

- Walls and ceiling: Powder-coated GI panels

- Civil finish: Compliant with GMP requirements

- Strategic sealing for efficient piping, cabling, and ducting

Regulatory Compliance:

Meets GMP requirements of:

- Schedule-M

- World Health Organization (WHO)

- U.S. Food and Drug Administration (FDA)

- European Union GMP standards

Facility Layout and Flow:

- Modular areas for unit operations

- Unidirectional process flow to prevent cross-contamination

- Sampling and dispensing conducted in downflow booths under reverse laminar air flow

Equipment and Technology:

- Latest equipment for granulation, pelletization, and oral film production

- Product contact surfaces made of SS 316L material

- High-capacity boiler/steam generator

- Oil-free, moisture-free compressed air system

Environmental Control:

- Dedicated HVAC system with individual AHUs for each unit operation

- Clean rooms of Class 100,000 (ISO Class-8)

- HEPA filters, differential pressure gradient, and temperature control

Water System:

- Double-pass reverse osmosis and mixed-bed water system

- Meets USP, EP, and IP grade purified water quality standards

Manufacturing Capabilities:

- Campaign-based manufacturing

- Batch size range: 350 kg - 1,500 kg

- Current capacity: 50 to 80 MT per month

Quality Assurance:

- Facility and process validations completed as per guidelines

Storage Facilities:

- Dedicated warehouses for API, raw materials, and packaging materials

- Separate finished goods store

- Quarantine and approved material demarcation in each area

- Cold storage available (2°C to 8°C) for temperature-sensitive materials

This state-of-the-art facility enables JPPL to maintain the highest standards of quality and efficiency in pharmaceutical manufacturing, ensuring our products meet global regulatory requirements and customer expectations.