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Manufacturing

FDF Manufacturing

We have two FDF facilities located about 40km apart from each other, for manufacturing sterile injectables and oral solids respectively. Our manufacturing operations are focused on therapeutic areas with unmet needs in selected markets, not necessarily the “Big” areas. The FDF facilities are equipped with top notch equipment to meet global regulatory and safety standards.

Sterile Injectables Facility

■ In compliance with cGMP standards

■ Certificated by China GMP 2010

Production activities involve the manufacture of small-volume sterile injectables, packaged in vials and ampoules. Strategic Dosage Forms include Lyophilized injectables, Prefilled Syringes, Ophthalmics, and with adequate space for 11 more production lines.

With its 200 employees, the site now handles over 40 different products. Regulatory registration include those of SFDA, WHO, Health Canada and US FDA. Inspection by Health Canada and inspection by WHO are expected during late 2016 and early 2017 respectively.

Sterile Injectables Capacity (Vials & Ampoules)

Volume Specification Ampoules (1ml) Ampoules (2ml) Ampoules (5ml) Ampoules (10ml) Ampoules (20ml)
Thousands pcs/Hour 30 30 24 20 18
Thousands pcs/Day 480 480 384 320 288
Thousands pcs/Year 144,000 144,000 115,200 96,000 86,400

Oral Solids Facility

■ In compliance with cGMP standards

■ Starting to operate in 2016

        This is a state of the art FDF facility with land area 52,000 m2 (12.9 acres) and Building area 36,000 m2. Strategic Dosage Forms include tablets, capsules and delayed or extended release formulations.

Viwit is actively pursuing licensing opportunities both in domestic market and in oversea markets. With our adequate capacities, Viwit manufacture Viwit® brand drugs and also provide CMO services for third parties. As a new facility, our first inspection by Health Canada will take place in the end of 2016.

Oral Solids Capacity (Tablets & Capsules)

Specification Tablets(11mm) Tablets(13mm) Tablets(16mm) Tablets(25mm) Capsules
Thousands pcs/Hour 800 650 550 450 200
Thousands pcs/Day 12,800 10,400 8,800 7,200 3,200
Thousands pcs/Year 3,840,000 3,120,000 2,640,000 2,160,000 960,000

API Manufacturing

API manufacturing is carried out in our cGMP compliance production facility which has been certified respectively by ISO9001:2008, Mexican COFEPRIS, and World Health Organization. Currently, we offer 500 cubic meters of reactor capacity which enables us to offer a wide range of toll manufacturing services for APIs and fine chemicals.

API Commercial Facility

■ Production of APIs, intermediates and fine chemicals under cGMP quality system

■ Batch size from hundreds of kilograms to tons

Our dedicated team combined with world-class production facilities and techniques guarantees timely delivery of products to customers throughout the world. API commercial facility is equipped with:

1000L to 3000L Glass-lined Reactors 95 1000L to 2000L SS Reactors 8
Vacuum and Warm-wind Cycle Dryers 19 Centrifuges 25
Mills 7 Refrigeration Unit 8
Temperature -25 oC to 200 oC Pressure Up to 8 Mpa

API Pilot Facility

■ Implementation of process development and optimization

Act as an important part of manufacturing, performing pilot batches for validation

Our processes are fully and vertically integrated from R&D to pilot to scaling up to commercial manufacturing. API pilot facility is equipped with:

200L to 500L Glass-lined Reactors 28 200L to 500L SS Reactors 8
Vacuum and Warm-wind Cycle Dryers 6 Centrifuges 7
Mills 3 Refrigeration Unit 3
Temperature -78 oC to 200 oC Pressure Up to 8 Mpa