Pharma Manufacturer

	Home
	Profile
	Products
	Manufacturing
	Quality
	Regulatory

Manufacturing

Our state-of-the-art manufacturing facilities are located in India with WHO-GMP certification and approval from major regulators around the world.

Neiss Labs has dedicated manufacturing areas for different dosage forms. The production areas are designed to maximize output quality and quantity with minimal down time. One such feature is the availability of a service floor above each sterile manufacturing area for providing the best manufacturing conditions and to enable the maintenance of the utilities without disturbing the sterile areas below.

he manufacturing areas at Neiss labs are broadly divided into sterile and semi-sterile areas. Both of these areas are supplied with forced air ventilation supplied by independent supply systems for individual department. All sterile areas are centrally air-conditioned and supplied by independent utility supply systems for individual department.

Formulations Manufactured

We have ability to manufacture small volume liquid parenterals, dry injections, pre-filled syringes (PFS), tablets, capsules, softgels, creams, gels and ointments. The critical work areas within the semi-sterile areas are also centrally airconditioned.

The independent supply systems are fed with separated air handling units to avoid cross air contamination. Pressure gradients are maintained and monitored and the required air quality of class 100, 1000, 10,000 and class 100,000 is maintained.The combination of man, material, machinery and systems enables Neiss Labs to produce a range of very high quality products. The well laid out and validated manufacturing process spanning all phases from raw material handling to finished goods storage is strictly followed for all product forms. Every step is documented in detail and historical data maintained for future reference.

LEAN Organization

We are striving to be a LEAN organization and have the customer central to all our activities.

Regulatory Support & Services

We can provide clinical Trials, FDA Certificates and BE Studies for registration of our products as per guidelines of health authorities in most countries. Our regulatory department is adept at providing complete documentation support in the form of regulatory dossiers for submission to health authorities.