CB21 Pharma extends EU GMP Certification for cannabinoid active pharma ingredients

Prague, Czechia: – Pioneering CBDepot sister company CB21 Pharma has successfully extended its EU Good Manufacturing Practice (GMP) certification to produce pharma-grade cannabinoid-based active pharmaceutical ingredients (APIs).

The extended GMP authorization issued under Czech State Institute for Drug Control allows CB21 Pharma to manufacture APIs such as Cannabidiol (CBD) from initial plant extraction through to full spectrum distilled and standardized extracts for medicinal use. The product complies with the Ph.Eur. Supplement 11.5. monograph 3151.

API-grade extracts are marketed under the CB21 trade names Cannabis Extractum Raffinatum and Cannabis Extractum Normatum. They comply with German pharmacopoeia monograph DAB 2020.

Innovative Cannabinoid leaders

CB21 Pharma is a pharmaceutical company that develops and markets innovative treatments for medical pathologies based on non-psychotropic cannabinoids combined with other active substances. The company also innovates, manufactures, and markets clean-label functional cosmetics for the 21st century.

In addition to its ongoing production, CB21 Pharma is also making strides in expanding its product portfolio. The company is diligently working towards introducing pharma-grade Dronabinol to the market by the end of this year in line with its mission to become a world leader in developing pharmaceutical products based on cannabinoids, utilizing evidence-based medicine, development processes, and regulatory and manufacturing expertise.

Research focus

The company’s focus on patient benefit is a constant driving force of its research program and achievements. By leveraging the most up-to-date science, preclinical and clinical development, and advanced technologies, the joint CBDepot and CB21 Pharma R&D Department ensures the highest quality of new products for the end user.

CBDepot Chief Sales Officer Boris Baňas, responsible for global substance sales in CB21 Pharma, commented: “The successful extension of the EU GMP certification is a significant and awaited milestone for CB21 Pharma and its expanding customer base that underlines the company’s commitment to maintaining the highest standards in its manufacturing processes and product quality.”

“It validates the company’s adherence to international manufacturing standards and reinforces its commitment to delivering high-quality, safe, and effective cannabinoid products to the global market”, Mr. Baňas added.

Growing product range

According to CBDepot CEO Jan Storch, “CB21 Pharma’s accomplishments demonstrate its commitment to quality and innovation in the pharmaceutical sector. As the company continues to grow and expand its product offerings, it remains steadfast in its mission to provide the highest quality cannabinoid ingredients for pharmaceutical use. This contribution to the advancement of medical science and the improvement of patient care worldwide”.

Boris Baňas and Jan Storch will jointly host a webinar on October 17, focusing on ‘Czech-Made EU GMP Cannabis-Derived APIs’ that will discuss the expanded portfolio of EUDRA-listed EU GMP CBD and EU GMP cannabis extracts fit for clinical trials and medicine development that can now be sourced in the Czech Republic.

CBDepot and CB21 will also be joint exhibitors at the upcoming CPHI Barcelona on October 24-26, ready to discuss projects featuring cannabinoid-based ingredients.

About CBDepot and CB21 Pharma

Established in 2014, CBDepot has established itself as a pioneering producer and B2B supplier of upmarket cannabinoid solutions, playing a leading role in establishing legal and quality standards for cannabinoid ingredients and the formulation of cannabidiol derivatives.

With its sister company, CB21 Pharma, this Czech group of innovative companies serves fast-growing markets in the food, cosmetics, pharmaceuticals, and health products sectors with high-quality natural and synthesized cannabinoids and cannabis-derived ingredients.

CBDepot’s current strapline “Upmarket Cannabinoid Solutions “reflects its new ability to offer cannabinoid ingredients and substances to various markets such as: cosmetic, food, and food supplements, with Europe-wide recognition as a strong, ethical and transparent supplier of cannabinoids. Meanwhile, CB21 Pharma has become a fully certified pharmaceutical company that manufactures cannabis-derived isolates and extracts to EU GMP standards.

CB21 Pharma is a pharmaceutical company established in autumn 2018. It focuses on developing treatments based on non-psychotropic cannabinoids combined with other active substances and has pioneered innovative medical therapies and functional cosmetics.

The companies share a common heritage and many key personnel, including Chief Sales Officer, Boris Baňas, formerly a board member of the European Industrial Hemp Association (EIHA), where he successfully campaigned for the establishment of new Europe-wide standards. CBDepot’s scientific knowledge is based on close links with the Czech Academy of Sciences.

Learn more at https://www.cbdepot.eu

Resources

Click on Czech-Made EU GMP Cannabis-Derived APIs to register for webinar.
Click on News from CBDepot  for further information.
Click on EUDRAGMDP and search under certificate Name: CB21 Pharma + Country: Czech republic for full details of extended GMP certification sukls105303/2023.