PIC/S

Completion of PIC/S Participating Authorities' Audits of Kexing Biopharm's Licensed Product Infliximab for Injection

Retrieved on: 
Tuesday, April 2, 2024
Certification, Brazilian Health Regulatory Agency, News, EPO, ANVISA, GMP, PIC/S, Infliximab, Food

New York, New York--(Newsfile Corp. - April 2, 2024) - The product infliximab for injection, licensed by Kexing Biopharm, has recently experienced a wave of encouraging news regarding its international commercialization.

Key Points: 
  • New York, New York--(Newsfile Corp. - April 2, 2024) - The product infliximab for injection, licensed by Kexing Biopharm, has recently experienced a wave of encouraging news regarding its international commercialization.
  • In addition, this month, the product has undergone a site GMP audit by another PIC/S Participating Authority, the Indonesian Food and Drug Authority (BPOM).
  • The company's proprietary product, human erythropoietin (EPO), has been present in Indonesia since 2005, gaining popularity and increasing market share.
  • In terms of infliximab, progress has been remarkable in the overseas factory inspection since the third quarter of 2023.

HYTN Welcomes Health Canada for Audit to Enhance GMP Capabilities

Retrieved on: 
Tuesday, April 9, 2024
Certification, Therapeutic Goods Administration, DEL, Sale, Psilocybin, IND, GMP, Cannabis, Investigational New Drug, Drug development, TGA, FDA, PIC/S, Pharmaceutical industry

VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, “HYTN” or “The Company”), a leader in the development, formulation, and manufacturing of products containing psychoactive and psychotropic compounds, including cannabis, welcomed Health Canada’s conduct of a Drug Establishment License (DEL) audit.

Key Points: 
  • VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, “HYTN” or “The Company”), a leader in the development, formulation, and manufacturing of products containing psychoactive and psychotropic compounds, including cannabis, welcomed Health Canada’s conduct of a Drug Establishment License (DEL) audit.
  • The audit, which aims to expand the Company's Good Manufacturing Practices (GMP) capabilities, follows the recent achievement of GMP certification for HYTN's Kelowna production facility by Australia's Therapeutic Goods Administration (TGA) under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) standard.
  • Securing a DEL will enhance HYTN's current GMP manufacturing capabilities, facilitating the development and sale of additional compounds and product variations.
  • HYTN has demonstrated its ability to manufacture these products according to GMP guidelines.

HYTN Provides Corporate Update, Outlines New Global Direction

Retrieved on: 
Wednesday, April 3, 2024
Certification, Good manufacturing practice, Therapeutic Goods Administration, The Company, DAB, European Pharmacopoeia, Quality management system, GMP, Cannabis, TGA, PIC/S, Drug

HYTN is announcing two strategic commercial initiatives underscoring the company’s commitment to leading the GMP-certified cannabis products industry.

Key Points: 
  • HYTN is announcing two strategic commercial initiatives underscoring the company’s commitment to leading the GMP-certified cannabis products industry.
  • HYTN expects to commercialize both business to business and wholesale opportunities under this initiative.
  • Additionally, HYTN aims to unlock global markets for established cannabis brands by leveraging the company's regulatory compliance, supply chain capabilities and Quality Management System.
  • The authorization to process cannabis flower into pharmaceutical-grade products for export provides a significant advantage in a market actively seeking GMP-certified cannabis."

HYTN Clears PIC/S GMP Audit, Primed for Global Expansion

Retrieved on: 
Monday, March 4, 2024
TGA, Growth, PIC/S, GMP, Psilocybin, Therapeutic Goods Administration, Certification, THC, Cannabis, Drink, Partnership

The positive outcome of the audit has set the stage for the subsequent issuance of formal GMP certification allowing the company to access international medical markets.

Key Points: 
  • The positive outcome of the audit has set the stage for the subsequent issuance of formal GMP certification allowing the company to access international medical markets.
  • The GMP audit conducted by the TGA was performed in accordance with the standards of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme ("PIC/S").
  • Once issued, GMP certification under the PIC/S framework allows HYTN to engage with international medical markets that recognize the PIC/S standard, through established reciprocal agreements.
  • This step also allows us to elevate our existing systems, bringing our current and future product offerings into compliance with GMP standards.”

Malaysian Patent Granted for CytoMed Therapeutics' Licensed Allogeneic CAR-Gamma Delta T Cell Technology

Retrieved on: 
Monday, January 29, 2024
Intellectual property, IPSC, NKT, NKG2D, GMP, License, Form, Risk, Cancer, PIC/S, Food, Antigen, The Intellectual Property Corporation, Patent, Clinical trial, News, Security (finance), Vaccine

“This grant adds to the breadth of our tumor-targeting therapy patent portfolio, alongside a US patent and Chinese patent in respect of this CAR T technology.

Key Points: 
  • “This grant adds to the breadth of our tumor-targeting therapy patent portfolio, alongside a US patent and Chinese patent in respect of this CAR T technology.
  • The Company’s patent portfolio also includes an exclusively licensed technology which covers an induced pluripotent stem cell (iPSC)-based technology to derive novel synthetic hybrid gamma delta natural killer T cells (γδ NKT cells) for the treatment of various types of cancers.
  • A patent for this proprietary technology has been granted in Japan and China, and this asset is under preclinical development.
  • For more information about the Company's services, latest news, and ongoing initiatives, please visit www.cytomed.sg.

Vantage Hemp Co. Concludes Audit with Australia’s Therapeutic Goods Administration

Retrieved on: 
Thursday, September 21, 2023
GMP, Regulation of therapeutic goods, Good manufacturing practice, Vantage, Therapeutic Goods Administration, ICH, Government, PIC/S, Documentation, Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, WHO, TGA, FDA, Cannabidiol, Medical device, Audit, CBD

Greeley, Colorado, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Vantage Hemp Co. (“Vantage” or the “Company”) announces the completion of a rigorous four-day audit conducted by Australia's Therapeutic Goods Administration (TGA), the country’s government authority responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods.

Key Points: 
  • Greeley, Colorado, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Vantage Hemp Co. (“Vantage” or the “Company”) announces the completion of a rigorous four-day audit conducted by Australia's Therapeutic Goods Administration (TGA), the country’s government authority responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods.
  • The audit, which took place from August 22-25, 2023, was a comprehensive assessment of Vantage’s operations, focusing on compliance with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the Therapeutic Goods Order No.
  • The process leading up to the audit spanned several months and included steps such as applying for exporter status, submitting documentation, and gaining approval for inspection.
  • The TGA auditor conducted a thorough examination of the Company's facilities, processes, and quality management systems.

Jacobson Pharma Announces FY2022 Annual Results

Retrieved on: 
Wednesday, June 29, 2022
Patient, Medication, Research, Marketing, COVID-19, Growth, Pramipexole, Company, Tax, JBM, Febuxostat, Guangdong-Hong Kong-Macau Greater Bay Area, Vaccination, Acceleration, Development, Department, Depreciation, EBITDA, Big White Duel, GMP, Acute promyelocytic leukemia, Idarubicin, Department of Health (Hong Kong), Fosun International, Fosun Pharma, Diabetes, Medical device, Conditional sentence, Greater, Dexmedetomidine, Health care, Public sector, Hospital, Board, PIC/S, HK, Analgesic, Sale, Amlodipine, The Group, University, Cardiovascular disease, Tablet, Immunity, Generic drug, Pharmaceutical industry, Vaccine, Valsartan, Group, Vaccine, Telmisartan, Brimonidine

HONG KONG, June 29, 2022 - (ACN Newswire) - Jacobson Pharma Corporation Limited ("Jacobson Pharma" or the "Company"; Stock Code: 2633), a leading company engaged in the research, development, production, marketing and sale of essential medicines, specialty drugs and branded healthcare products, today announced the annual results of the Company and its subsidiaries (collectively the "Group") for the year ended 31 March 2022 ("FY2022" or the "Reporting Period").

Key Points: 
  • HONG KONG, June 29, 2022 - (ACN Newswire) - Jacobson Pharma Corporation Limited ("Jacobson Pharma" or the "Company"; Stock Code: 2633), a leading company engaged in the research, development, production, marketing and sale of essential medicines, specialty drugs and branded healthcare products, today announced the annual results of the Company and its subsidiaries (collectively the "Group") for the year ended 31 March 2022 ("FY2022" or the "Reporting Period").
  • About Jacobson Pharma Corporation Limited (Stock Code: 2633)
    Jacobson Pharma is a leading pharmaceutical company in Hong Kong vertically integrated and engaged in the research, development, production, sale and distribution of essential medicines and specialty drugs.
  • Jacobson Pharma has been a constituent stock of MSCI Hong Kong Micro Cap Index since 1 June 2017.
  • For more details about Jacobson Pharma, please visit the Group's website: http://www.jacobsonpharma.com
    Copyright 2022 ACN Newswire .

Ban Loong, Jacobson & JBM Form Joint Venture to Tap Specialty Drugs and Branded Healthcare Markets in Greater China and Asia

Retrieved on: 
Wednesday, June 15, 2022
International joint venture, GMP, Health care, Jacobson, ASEAN, Health, Research, Growth, Marketing, Joint venture, JBM, Acquisition, Partnership, PIC/S, Group, Awareness, Sale, Management, Pharmaceutical industry

Indeed, a strong growth forecast is also expected in the next few years, with an average annual growth rate of over 9% in the pharmaceutical and healthcare markets in China.

Key Points: 
  • Indeed, a strong growth forecast is also expected in the next few years, with an average annual growth rate of over 9% in the pharmaceutical and healthcare markets in China.
  • Mr. Raymond Yim, Executive Director of Jacobson, said, "We are very honored to partner with Ban Loong and aspire to strengthen our foothold through the Joint Venture in Greater China and markets in Asia.
  • For more details about Jacobson Pharma, please visit the Group's website: http://www.jacobsonpharma.com
    About JBM (Healthcare) Limited (Stock Code: 2161)
    JBM Healthcare is a Hong Kong-based company that markets and distributes branded healthcare products across Greater China, Southeast Asia and certain other countries.
  • JBM Healthcare has been a constituent stock of the MSCI Hong Kong Micro Cap Index since 27 May 2021.

Jacobson Pharma's Chairman Uplifts Shareholding to Above 60%

Retrieved on: 
Monday, March 14, 2022
GMP, Company, Marketing, Research, PIC/S, Mergers and acquisitions, Face, Sale, The Group, Growth, Fine chemical, Group

The above share purchase represents approximately 1.06% of the total issued share capital of the Company as at 14 March 2022.

Key Points: 
  • The above share purchase represents approximately 1.06% of the total issued share capital of the Company as at 14 March 2022.
  • Mr Sum said he might consider further increasing his shareholding in the Company subject to the applicable laws and regulations.
  • Jacobson Pharma has been a constituent stock of MSCI Hong Kong Micro Cap Index since 1 June 2017.
  • For more details about Jacobson Pharma, please visit the Group's website: http://www.jacobsonpharma.com
    Copyright 2022 ACN Newswire .

Global Pharmaceutical Cleaning Validation Market Share, Size, Trends, & Industry Analysis Report 2021-2028 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 1, 2022
Health, Pharmaceutical, Adoption, SA, Purdue University, Investment, Forecasting, Industry, European Medicines Agency, Regulation of tobacco by the U.S. Food and Drug Administration, Suez, State, Intertek, PIC/S, Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, Shimadzu, Merck, EMA, Peptide, Growth, Occupational exposure limit, United States Pharmacopeia, Waters Corporation, SGS, Limited partnership, Partnership, Medical device, Fine chemical, Test

The "Pharmaceutical Cleaning Validation Market Share, Size, Trends, Industry Analysis Report, By Product; By Test; By Region; Segment Forecast, 2021 - 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Pharmaceutical Cleaning Validation Market Share, Size, Trends, Industry Analysis Report, By Product; By Test; By Region; Segment Forecast, 2021 - 2028" report has been added to ResearchAndMarkets.com's offering.
  • Besides, rising government support and approvals for evolving products such as small molecules, peptides, etc., for the development of the pharmaceutical industry, as well as rising demand for cleaning validation, are contributing towards the market growth across the globe.
  • Accordingly, these factors propel the demand for cleaning validation for pharmaceutical manufacturers and contribute to industry development in the near future.
  • For instance, in August 2021, Purdue University came into partnership with the US Pharmacopeia after receiving incentives from Aprecia Pharmaceuticals to introduce pharmaceutical validation industry technology forum.