AqVida is now US FDA inspected

AqVida, Dassow-based pharmaceutical company, successful in inspection by the US Food and Drug Administration (FDA)

AqVida, Northern German pharmaceutical company, successfully inspected by US Food and Drug Administration (FDA)

Hamburg/Dassow, 9th of June 2022

Oncology generics manufacturer AqVida was inspected by the U.S. Food and Drug Administration (FDA) from May 26 to June 3. Passing this inspection opens up further global markets for the northern German company, which started up its production facility in Dassow in 2016.

The 'FDA approved' status now supplements the EU manufacturing authorization - the so-called EU GMP certificate, which has been in place since the start of operations. AqVida thus has the two most prestigious certifications in the pharmaceutical sector worldwide.

In principle, the American and European offices recognize each other's certificates, but the confirmation by the US authorities is internationally highly regarded and creates additional confidence. Approval for the U.S. market is therefore not only important to enable drugs manufactured in Dassow to access the U.S. market - the FDA certificate is an important door opener into other important markets that recognize the American approval.

The Dassow production facility, which houses manufacturing and filling, packaging, warehousing, two laboratories and quality assurance, also receives an additional seal of quality from the successful inspection.

US FDA

The U.S. agency's registration process is considered one of the toughest in the world. The FDA, the Food and Drug Administration, is responsible for the approval and market surveillance of food, drugs and medical products in and for the USA. In doing so, it is vested with far-reaching powers.

The agency is known (and feared) for its intensive on-site inspections. Failure to pass the certification process, for example due to too many discrepancies in the local inspection, results in an import ban for the product to be affected or the company's entire portfolio.

Company AqVida

The pharmaceutical company, based in Hamburg as well as Northwest Mecklenburg, specializes in the development, approval, manufacture and distribution of oncology products.

The portfolio includes the main generic drugs used for chemotherapy in the treatment of the most common forms of cancer, including breast, colorectal and lung cancer, for example. The company's own production facility in northern Germany allows it to operate reliably while remaining flexible.

"I am proud of all colleagues* who have contributed to making AqVida a highly professional participant in the pharmaceutical market within a short period of time," said Wolfgang Heinze, managing director at AqVida. According to Heinze, in view of the comprehensive regulatory requirements in the pharmaceutical sector, one can certainly speak of record time, if within a good 5 years from the establishment of the production facility, the two most important pharmaceutical certificates in the world could be obtained.

The employees played a decisive role in this. Currently, almost 90 people of more than 20 nationalities work for the company. "We are also feeling the shortage of skilled workers that many people are talking about," says Heinze. He explains, "At first glance, Northwest Mecklenburg doesn't seem interesting, but our location between the cities of Lübeck and Wismar - near the sea - is very attractive, and the quality of life is high." AqVida also provides unbureaucratic support where it can. For example, help has already been provided in an uncomplicated manner when dealing with authorities, finding housing in the region or taking advantage of vaccination offers, even without a standard relocation team.

"When it comes to product quality, standards and regulatory requirements are our minimum standards. But in general, AqVida is not about 'checking off' standards, it's about getting things done in the best way possible. Whether it's hiring new colleagues or obtaining FDA certification in a relatively short time. And that also applies to our products: Even if we produce so-called copycat products, it is always important to us to improve these products in terms of the best possible treatment of patients, where it makes sense and is possible within the regulatory framework," Heinze explains.

AqVida is growing continuously and is constantly looking for motivated and qualified employees. Currently, positions are available in the areas of production, microbiology and quality assurance.

AqVida at the Dassow site

In 2016, AqVida opened its high-tech production facility in Northwest Mecklenburg, where it has since launched a total of ten products and is constantly working on new developments in the generic area.

At the Dassow site in the Holmer Berg industrial estate, the company had previously found a plot of land tailored to its needs. In addition to good logistical connections and proximity to the Hamburg headquarters, cooperative interaction with the authorities and the municipality also played a role. "Right from the start, the cooperation has worked very well," says a pleased Wolfgang Heinze.

Key facts: AqVida at the Dassow site

Company profile
Generics manufacturing company with innovative strength: AqVida optimizes products where this is possible and makes sense

Jobs at the site: 59 (2016: 23)
Thereof apprenticeships: 3

Activities at the site

Preparation & Filling

Inspection & packaging

Warehouse & logistics

Manufacturing service

Microbiological Laboratory

Chemical-physical laboratory
Quality Assurance
Packaging

AqVida developed an innovative robotic filling line for the highest safety standards in the aseptic production of cytostatics for parenteral use, i.e. liquid concentrates for the treatment of cancer:

Highest clean room standards
State-of-the-art isolator technology protects products from contamination in the production process.

Robotic control & virtually no format parts
The largely automated production process increases the aseptic safety of the products to the highest level.

Filling of cytostatics as well as ADCs possible
The OEB5 clean room class and isolator technology allow the filling of toxic concentrates and antibody drug conjugates (ADCs).

Flexible and efficient
High flexibility in filling sizes and bulk batch size,
Virtually no loss of product liquid,
100% weight control,
High-precision robotic technology, especially for small batches.

Innovative
Awarded the CPhI Pharma Award for excellence in manufacturing and technology.

Back to the news

AqVida GmbH

Premium Oncology Products

Quality - Made in Germany

We are available for current company topics and interview requests:

Saskia Heinze

Claudia Schubert

Phone: +49 (0) 40/380 371 9 - 0

Mail: pr@aqvida.com

Hamburg/Dassow, 9th of June 2022

Oncology generics manufacturer AqVida was inspected by the U.S. Food and Drug Administration (FDA) from May 26 to June 3. Passing this inspection opens up further global markets for the Northern German company, which started up its production facility in Dassow in 2016.

The 'FDA approved' status now adds to the EU manufacturing authorization, the EU GMP certificate, which has been in place since the start of operations. Thus AqVida has the two most prestigious certifications in the pharmaceutical sector worldwide.

In principle, the American and European offices recognize each other's certificates, but the confirmation by the US authorities is internationally highly regarded and creates additional confidence. Approval for the U.S. market is therefore not only important to enable drugs manufactured in Dassow to access the U.S. market - the FDA certificate is a door opener into other important markets that recognize the American approval.

US FDA

The U.S. authority's registration process is considered one of the toughest in the world. The FDA, the Food and Drug Administration, is responsible for the approval and market surveillance of food, drugs and medical products in and for the USA. In doing so, it is vested with far-reaching powers.

The FDA is known (and feared) for its intensive on-site inspections. Failure to pass the certification process, for example due to too many findings and deviations in the local inspection, results in an import ban for the product or the company's entire portfolio.

Company AqVida

The pharmaceutical company, based in Hamburg as well as Northwest Mecklenburg (Northern Germany), specializes in the development, approval, manufacture and distribution of oncology products.

The portfolio includes the main generic drugs used for chemotherapy in the treatment of the most common forms of cancer, including breast, colorectal and lung cancer, for example. The company's own production facility in Northern Germany allows it to operate reliably while remaining flexible.

"I am proud of all colleagues, who have contributed to making AqVida a highly professional participant in the pharmaceutical market within a short period of time," said Wolfgang Heinze, Managing Director at AqVida. According to Heinze, in view of the comprehensive regulatory requirements in the pharmaceutical sector, one can certainly speak of record time, if within a good 5 years from the establishment of the production facility the two most important pharmaceutical certificates in the world could be obtained.

The employees played a decisive role in this. Currently, more than 90 people of more than 20 nationalities work for the company. "We are also feeling the shortage of skilled workers that many companies in Germany are talking about," says Heinze. He explains, "At first glance, Northwest Mecklenburg doesn't seem interesting, but our location between the cities of Lübeck and Wismar - near the sea - is very attractive, and the quality of life is high." AqVida also provides unbureaucratic support where it can. For example, help has already been provided in an uncomplicated manner when dealing with authorities, finding housing in the region or taking advantage of vaccination offers, even without a standard relocation team.

"When it comes to product quality, standards and regulatory requirements are our minimum standards. But in general, AqVida is not about 'checking off' standards, it's about getting things done in the best way possible. Whether it's hiring new colleagues or obtaining FDA certification in a relatively short time. And that also applies to our products: Even though we produce generics it is always important to us to improve these products with the objective of the best possible treatment for patients, where it makes sense and is possible within the regulatory framework," Heinze explains.