Opinion – Cannabis Inc.: Anvisa approves four Cannabis products in May

May was a good month for pharmaceutical companies in cannabis in Brazil. Many of them were complaining that the issuance of licenses was a little slow, but only in that period four products received a license from Anvisa (Sanitary Surveillance Agency) to be commercialized in the national market.

Since 2019, when RDC 327 was published, the agency has granted health authorization for products, as long as they meet the standards required for all medicines, which are now on pharmacy shelves. This implies a series of laboratory tests and documents to ensure that they do not put the health of the consumer at risk. Even so, the agency determines that extracts from cannabis they are not medicines, but products.

There are 19 CBDs (Cannabidiol, substance without psychoactives) with sanitary approval for the trade. The most recent to receive the green light from the agency was produced by Promediol do Brasil in a 30 ml bottle, with 50 mg/ml. “This is our second approval. The first was last year, in a presentation with 10 ml”, says Adriana Schulz, director and partner of the company, based in Switzerland.

Greencare was also authorized to market the 160.32 mg/ml extract, the first on the Anvisa list approved with more than 0.2% THC (tetrahydrocannabidiol, a psychoactive substance in Cannabis). The higher concentration opens up a wider range for the treatment of diseases. Another company contemplated was Mantecorp Farmasa – which has a portfolio of well-known products in the market, such as Addera D3, Predsim and Rinosoro, among others – in two presentations (160.32 mg/ml and 79.14 mg/ml). One of them also had a THC concentration greater than 0.2%.

Below are all the products that already have a license for commercialization.

• Cannabis Promediol Extract (50mg/ml)
• extract from cannabis sativa Greencare (160.32 mg/ml).
• extract from cannabis sativa Mantecorp Farmasa (160.32 mg/ml).
• extract from cannabis sativa Mantecorp Farmasa (79.14 mg/ml).
• Cannabidiol Prati-Donaduzzi (20 mg/mL; 50 mg/mL and 200 mg/mL).
• NuNature Cannabidiol (17.18 mg/mL).
• NuNature Cannabidiol (34.36 mg/mL).
• Cannabidiol Farmanguinhos (200 mg/mL).
• Cannabidiol Verdemed (50 mg/mL).
• Cannabidiol Belcher (150 mg/mL).
• Cannabidiol Aura Pharma (50 mg/ml).
• Cannabidiol Greencare (23.75 mg/mL).
• Cannabidiol Verdemed (23.75 mg/mL).
• extract from cannabis sativa Promediol (200 mg/ml).
• extract from cannabis sativa Zion Medpharma (200 mg/ml).
• extract from cannabis sativa Cann10 Pharma (200 mg/ml).
• extract from cannabis sativa Greencare (79.14 mg/ml).
• extract from cannabis sativa Ease Labs (79.14 mg/ml).
• Cannabidiol Active Pharmaceutica (20 mg/ml).