News
VUAB Pharma Ltd. has received Certificate of GMP Compliance of a Manufacturer
VUAB Pharma Ltd. has received Certificate of GMP following an inspection in accordance with ASrt. 111(5) of Directive 2001/83/EC and Section 13, paragraph 2, letter a, point 3 of the Act No 378/2007 Coll., on Pharmaceuticals. The competent authority of the Czech Republic confirms that VUAB Pharma a.... more
Successful participation in the largest pharmaceutical exhibition CPhI in Barcelona
The staff of business section participated during October 2016 in the largest pharmaceutical exhibition CPhI in Barcelona. On our own stand during the three days took place over more than 100 business meetings with traditional partners, but also with new customers interested in our products. Already... more
FDA completed review of “EIR”
FDA completed their investigation in connection with our own applications VUAB Pharma Inc. for the inspection at our active pharmaceutical ingredient manufacturing facility in Roztoky, Czech Republic which took place on 3-5 11th 2015. In an accompanying letter, the FDA states that they are classify... more
Certificate of GMP Compliance of a Manufacturer for VUAB Pharma – Nystatin
On 3rd March 2016 issued the competent authority of Czech Republic – State Institute for Drug Control – the Certificate of GMP Compliance of a Manufacturer for VUAB Pharma for Manufacturing, General Finishing Steps and Quality Control Testing of API Nystatin. This Certificate confirms th... more
Official statement of VUAB Pharma a.s. to the Warning letter issued by the U.S. FDA regarding the active substance Nystatin and its audit.
VUAB Pharma herewith declare to operate fully in terms of cGMP, i.e. Good manufacturing practice. Quality of Nystatin –API is of high-grade, the results of the control measurements show much lower parameters than binding international limits prescribed by the European, British and the U.S. Pharmacop... more
Visit us at CPhI 2015
The company VUAB Pharma is preparing the presentation of the entire product portfolio for the CPhI fair that will be held from 13 to 15 October 2015 in Madrid. The main objective of participation in the fair is a meeting with traditional partners and discuss the plan for the year 2016. Also, establi... more
Modernization of the Nystatin production completed
In March 2015, we completed the modernization of cleanroom production Nystatin. This modernization will increase the production capacity of this important product. VUAB Pharma a.s. belongs to the three biggest manufacturers in the world. more