Good Manufacturing Practices (GMP)
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WuXi Vaccines Receives Brazil's ANVISA GMP Certification
Prnewswire· 2026-02-12 03:48
WuXi Vaccines Receives Brazil's ANVISA GMP Certification [Accessibility Statement] Skip NavigationSUZHOU, China, Feb. 11, 2026 /PRNewswire/ -- WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, dedicated to vaccine Contract Development and Manufacturing Organization (CDMO), announced today that it has received Good Manufacturing Practices (GMP) certification for its fill and finish facility (DP17) in Suzhou from Brazil's Agência Nacional de Vigilância Sanitária (ANVISA). The facility is providing i ...
MediPharm Labs to Enter New Market with Costa Rica Supply Agreement
Globenewswire· 2026-01-13 13:00
Core Viewpoint - MediPharm Labs Corp. has signed a definitive supply agreement with Remidose Aerosols Inc. to ship GMP-certified medicinal cannabis products to Costa Rica, enhancing its commitment to support medical patients in the region and expand international access to quality cannabis solutions [1][2]. Company Overview - MediPharm Labs specializes in precision-based cannabinoids and operates a GMP-certified facility for the development and manufacture of pharmaceutical-quality cannabis products [6]. - The company has a strong focus on research-driven methodologies and advanced technology for producing pure and precision-dosed cannabis products [6]. - In 2021, MediPharm Labs became the only company in North America to hold a commercial-scale domestic GMP License for the extraction of multiple natural cannabinoids [7]. - The acquisition of VIVO Cannabis Inc. in 2023 expanded MediPharm's reach to medical patients in Canada, Australia, and Germany [8]. Market Context - Costa Rica's medical cannabis market opened for regulated sales in June 2025 and is projected to exceed USD 35 million annually, driven by strong patient demand and a comprehensive regulatory framework [2]. - The partnership with Remidose LATAM aims to provide high-quality, GMP-certified cannabis products to meet the needs of patients in Costa Rica [4]. Agreement Details - Under the agreement, MediPharm Labs will supply a variety of GMP-certified cannabis products, including oils, tinctures, metered dose inhalers, and dried flower to Remidose LATAM [3]. - Remidose LATAM is fully licensed by Costa Rican health authorities to import medicinal cannabis products, ensuring compliance with local regulations [4][5].
HYTN Secures Cannabis Drug Licence, Advancing Prescription Drug Pathway for Cannabinoid-Based Medicines
Globenewswire· 2025-07-14 12:00
Core Viewpoint - HYTN Innovations Inc. has received a Cannabis Drug Licence (CDL) from Health Canada, allowing the company to manufacture cannabis-derived pharmaceutical drugs, enhancing its capabilities in the pharmaceutical market [1][2][3]. Company Developments - The CDL complements HYTN's existing Drug Establishment Licence (DEL) and allows for the fabrication, packaging, labelling, and distribution of prescription pharmaceutical products [1][2]. - With the CDL, HYTN can support clinical research, generate regulatory data, and pursue future drug approvals and market authorizations [2][3]. - The company is now positioned to expand its operations beyond GMP-cannabis frameworks into pharmaceutical drug development [3]. Market Context - The global pharmaceutical industry is increasingly integrating cannabinoids as active pharmaceutical ingredients (APIs), with Epidiolex generating net product sales of USD $972.4 million in 2024 and a gross margin of 88.2% [4]. - Despite advancements, access to GMP-compliant cannabis-derived APIs and finished drug products remains limited due to high regulatory standards [5]. Strategic Advantages - HYTN's CDL allows it to participate in the global supply chain for cannabinoid-based therapeutics through internationally compliant manufacturing and strategic pharmaceutical partnerships [5]. - The company operates under a DEL for non-sterile pharmaceuticals and complies with international GMP standards recognized by the UK, EU, and Australia [6]. - HYTN is progressing with its EudraGMDP registration, which would enable it to be listed as an approved API and drug product manufacturer within European pharmaceutical databases [6]. Target Markets - HYTN aims to serve clinical-stage pharmaceutical sponsors and biotech companies seeking GMP cannabinoid inputs, as well as distributors and pharmacies operating under prescription-only frameworks in Europe, the UK, and Australia [7]. - The company is also targeting special access programs and government tenders focused on regulated cannabinoid therapies [7]. Company Overview - HYTN Innovations Inc. specializes in the formulation, manufacturing, marketing, and sale of products containing psychoactive and psychotropic compounds, including cannabis-derived cannabinoids [8]. - The company is dedicated to becoming a premier provider of these products across federally regulated markets by identifying market opportunities and bringing innovative products to market [8]. Regulatory Framework - A Cannabis Drug Licence (CDL) is required for companies intending to manufacture prescription drugs containing cannabis for human use, ensuring compliance with the same regulatory standards as conventional pharmaceutical manufacturers [9]. - Good Manufacturing Practices (GMP) guidelines ensure that manufactured products are safe for human consumption, with many countries legislating adherence to these standards [10].
HYTN Receives Initial International Purchase Order for GMP Vape Cartridges
Globenewswire· 2025-06-11 12:00
Core Insights - HYTN Innovations Inc. has received its first purchase order and import permit for GMP cannabis vape cartridges, marking a significant milestone for the company [1][2] - The initial order consists of 1,000 one-gram live resin vape cartridges, which will be manufactured in compliance with GMP standards and exported to the UK, pending regulatory approvals [2] - The company emphasizes its commitment to quality and safety in its pharmaceutical-grade cannabis offerings, aiming to serve regulated international markets [2][3] Company Overview - HYTN Innovations Inc. specializes in the formulation, manufacturing, marketing, and sale of products containing psychoactive and psychotropic compounds, including cannabis-derived cannabinoids [4] - The company aims to become a premier provider of these products across federally regulated markets by identifying market opportunities and innovating product development [4] GMP Compliance - Good Manufacturing Practices (GMP) guidelines ensure that manufactured products are safe for human consumption, and many countries require adherence to these standards [5] - The company's compliance with GMP standards is crucial for its operations and international market access [2][3]