Latest news with #cGMP
Associated Press
2 days ago
- Business
- Associated Press
Full Alliance Group's Pure Solutions Announces Manufacturing Agreement With Stemtech Corporation for New StemPets(TM) Product Line
TAMPA, FL / ACCESS Newswire / June 2, 2025 / Pure Solutions Inc., a wholly owned subsidiary of Full Alliance Group, Inc. (OTC:FAGI), today announced a strategic manufacturing agreement with Stemtech Corporation (STEK) to produce their newly released StemPets™ product line. This partnership marks a significant expansion of Pure Solutions' manufacturing capabilities and strengthens Full Alliance Group's position in the growing pet wellness market. Under the terms of the agreement, Pure Solutions will handle all manufacturing aspects of StemPets™, Stemtech's innovative stem cell nutrition product specifically formulated for companion animals. Production has already begun at Pure Solutions' state-of-the-art facility in Tampa, Florida. Strategic Expansion into Pet Wellness Market The collaboration comes at a pivotal time as the global pet supplement market continues to experience unprecedented growth, projected to reach $3.9 billion by 2027, according to recent industry analyses. StemPets™ represents Stemtech's entry into this lucrative market segment with a product that leverages their established expertise in stem cell nutrition. 'This manufacturing agreement with Stemtech represents a significant opportunity for Pure Solutions and our parent company, Full Alliance Group, " said Bill Heneghan, COO of Full Alliance Group. 'The pet wellness sector is experiencing remarkable growth, and this partnership allows us to leverage our manufacturing expertise while expanding our footprint in this promising market.' StemPets™ utilizes Stemtech's proprietary blend of natural ingredients designed to support the release of adult stem cells in pets, potentially improving overall health, mobility, and quality of life for companion animals. The product addresses a growing consumer demand for science-backed pet wellness solutions. Manufacturing Excellence and Capacity Pure Solutions brings extensive manufacturing capabilities to this partnership, including advanced production facilities that meet stringent quality control standards. The company's manufacturing processes adhere to Current Good Manufacturing Practice (cGMP) regulations, ensuring consistent product quality and safety. 'Our manufacturing facilities are uniquely positioned to handle the specialized requirements of Stemtech's innovative formulations,' said Natalie Collins, Production Director at Pure Solutions. 'We've invested significantly in both equipment and personnel to ensure we can deliver the highest quality products while maintaining the proprietary aspects of Stemtech's formulations.' The agreement includes provisions for scaled production to meet anticipated demand growth, with initial production runs beginning this quarter. Pure Solutions has implemented dedicated production lines to accommodate the specialized requirements of the StemPets™ formulation. Market Opportunity and Growth Potential The pet supplement industry has seen dramatic growth in recent years, fueled by increasing pet ownership rates and growing consumer awareness of pet health issues. According to industry data, approximately 67% of U.S. households now own pets, with owners increasingly seeking premium wellness products for their animal companions. StemPets™ targets this premium segment with a science-based approach to pet wellness. The product's formulation draws on Stemtech's 20+ years of research and development in stem cell nutrition, adapted specifically for companion animals. 'The pet wellness market represents a natural extension of Stemtech's human wellness product line,' commented Charles S. Arnold, Chief Executive Officer at Stemtech Corporation. 'We selected Pure Solutions as our manufacturing partner because of their demonstrated commitment to quality, their technical capabilities, and their ability to scale production as demand increases.' Market research indicates pet owners are increasingly willing to invest in premium health products for their companions, with spending on pet supplements growing at approximately 5.9% annually. The StemPets™ product line is positioned to capitalize on this trend with its advanced formulation and scientific backing. Financial Impact and Growth Strategy For Full Alliance Group and its subsidiary Pure Solutions, the manufacturing agreement is expected to contribute significantly to revenue growth in the coming quarters. While specific financial terms were not disclosed, company officials indicated the initial production agreement spans multiple years. The company anticipates that the Stemtech partnership will drive facility utilization rates higher while creating economies of scale that benefit Pure Solutions' overall manufacturing operations. Additional staff hiring is planned to support the increased production demands. Product Innovation and Development StemPets™ represents the culmination of extensive research and development efforts by Stemtech to adapt their stem cell nutrition technology for companion animals. The product formulation includes a proprietary blend of natural ingredients that have been shown to support the release and activity of adult stem cells in animals. Pure Solutions' technical team worked closely with Stemtech's scientists to ensure the manufacturing process preserves the integrity of these specialized ingredients. The collaboration included extensive testing and validation protocols to confirm product efficacy and stability. The initial StemPets™ product line includes formulations for dogs and cats. Pure Solutions' flexible manufacturing capabilities will accommodate this expanding product line as new formulations are introduced. About Full Alliance Group, Inc. Full Alliance Group, Inc. (OTC:FAGI) is a holding company in the health and wellness sector. FAGI's wholly owned subsidiary, Bio Lab Naturals, Inc., founded in 2000, through its FDA-registered wholly owned subsidiary Pure Solutions, Inc., was built on the simple principles of using the highest quality ingredients, producing products with the greatest possible efficacy, and providing its partners with unsurpassed customer service all at a fair price. From day one, the Company has specialized in custom product development and FDA-compliant contract manufacturing, with a passion for cutting-edge formulations and innovative product selection. Now housed in a state-of-the-art 25,000 square foot facility in Tampa, Pure Solutions remains committed to its founding principles and is ready to expand its operations through growing organically by adding diversity to its in-house product lines and strategically through joint ventures, partnerships, acquisitions, exclusive manufacturing and distribution agreements, and mergers. About Stemtech Corporation Stemtech Corporation (STEK) is the pioneer in the field of stem cell nutrition, developing innovative products that support the body's natural renewal system. For over 20 years, Stemtech has led the market with science-based formulations that promote wellness through supporting the body's natural stem cell processes. The company's product line includes nutritional supplements for humans and now extends to companion animals with the StemPets™ product line. Forward-Looking Statements This announcement contains forward-looking statements within the meaning of the 'safe harbor' provisions of the U.S. Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those identified by words such as 'believes,' 'will,' 'expects,' 'anticipates,' 'estimates,' 'intends,' 'plans,' 'targets,' 'projects' and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in these forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, the results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, the impact of any competitive products, our ability to license and protect our intellectual property, our ability to raise additional capital in the future, changes in government policy and/or regulation, potential litigation by or against us, any governmental review of our products or practices, and other risks discussed from time to time in our filings with the Securities and Exchange Commission. We undertake no obligation to update any forward-looking statements, or any information contained in this press release or in other public disclosures, at any time. Finally, the investing public is reminded that only announcements or information about Stemtech Corporation disseminated by the Company and bearing its name are considered official. Media Contact: Full Alliance Group Inc. Investor Relations Gabe Rodriguez, Erelations Group [email protected] (623) 261-9046 For Stemtech Investor Relations Information Contact: Charles S. Arnold, CEO Stemtech Phone: 336-918-0507 Email: [email protected] Stemtech Corporation Phone: +1 954-715-6000 ext 1040 Email: [email protected] SOURCE: Full Alliance Group, Inc. press release
Business Standard
2 days ago
- Business
- Business Standard
Alembic Pharma slips as USFDA issues four observations for Panelav API facility
Alembic Pharmaceuticals declined 1.28% to Rs 1,004.20 after the United States Food and Drug Administration (USFDA) issued Form 483 with four observations to the company's Panelav API-I & II facility. According to a regulatory filing, the USFDA conducted an unannounced and routine current good manufacturing practices (cGMP) inspection at the companys API-I and API-II facilities located at Panelav from 26 May 2025 to 31 May 2025. The USFDA issued a form 483 with four observations and none of the observations are related to data integrity and management believes that they are addressable. The company will provide comprehensive response to USFDA for the observations within the stipulated period. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24.
Business Standard
2 days ago
- Business
- Business Standard
Cipla's Bengaluru facility gets one USFDA observation
Cipla announced that the United States Food and Drug Administration (USFDA) has concluded a current Good Manufacturing Practices (cGMP) inspection at its manufacturing facility in Bommasandra, Bengaluru. According to a regulatory filing, the inspection was carried out from 26 May 2025 to 30 May 2025. At the conclusion of the inspection, the USFDA issued one observation in Form 483. The company stated that it will work closely with the USFDA and remains committed to addressing the observation comprehensively within the stipulated timeframe. In Q4 FY25, Cipla reported a 30.1% year-on-year increase in consolidated net profit to Rs 1,222 crore, while total income rose 9.2% to Rs 6,730 crore. Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolios in our home markets of India, South Africa, North America, and key regulated and emerging markets. The scrip shed 0.19% to currently trade at Rs 1,462 on the BSE.
Business Upturn
2 days ago
- Business
- Business Upturn
Alembic Pharma shares dip over 2% after USFDA issues 4 observations for Panelav facility
By Aman Shukla Published on June 2, 2025, 10:25 IST Shares of Alembic Pharmaceuticals fell over 2% on Monday following news that the United States Food and Drug Administration (USFDA) issued four observations after inspecting the company's API-I & II facility at Panelav, Gujarat. As of 10:22 AM, the shares were trading 1.88% lower at Rs 998.90. The unannounced, routine cGMP (current Good Manufacturing Practices) inspection was conducted between May 26 and May 31, 2025. At the conclusion of the inspection, the USFDA issued a Form 483 outlining four observations. Importantly, Alembic confirmed that none of the observations relate to data integrity — a key concern for regulators and investors. The company stated that it will submit a comprehensive response to the USFDA within the required timeframe. Management emphasized that the issues raised are 'addressable' and reiterated its commitment to maintaining high standards of quality and regulatory compliance. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Yahoo
5 days ago
- Business
- Yahoo
United States Biopharmaceuticals Contract Manufacturing Research Report 2025: Rising Demand for Biologics and Biosimilars - Trends, Regional Insights, Competition, Forecast & Opportunities, 2020-2030F
The U.S. Biopharmaceuticals Contract Manufacturing Market is poised for growth, driven by rising demand for biologics and biosimilars and advancements in manufacturing technologies like single-use systems. These trends improve cost-efficiency and scalability, catering to the need for specialized production in personalized medicine. U.S. Biopharmaceuticals Contract Manufacturing Market Dublin, May 29, 2025 (GLOBE NEWSWIRE) -- The "United States Biopharmaceuticals Contract Manufacturing Market, By Region, Competition, Forecast & Opportunities, 2020-2030F" has been added to offering. The United States Biopharmaceuticals Contract Manufacturing Market was valued at USD 10.58 Billion in 2024, and is expected to reach USD 19.52 Billion by 2030, rising at a CAGR of 10.72% This growth is largely fueled by rising demand for biologics and biosimilars used to treat complex diseases through advanced therapies. Evolving manufacturing technologies - such as single-use systems and continuous processing - are improving efficiency and scalability. These innovations enable contract manufacturers to deliver cost-effective, high-quality solutions while supporting the increasing need for flexible, specialized production capabilities, especially for cell and gene therapies and personalized medicines. Rising Demand for Biologics and Biosimilars The growing demand for biologics and biosimilars is a key factor accelerating the expansion of the United States Biopharmaceuticals Contract Manufacturing Market. Biologics, including monoclonal antibodies, recombinant proteins, vaccines, and cell and gene therapies, are vital in treating complex and chronic conditions like cancer and autoimmune disorders. These therapies offer high precision and effectiveness, making them valuable in personalized medicine. As of April 1, 2025, the FDA has licensed 69 biosimilars, with 49 launched for 17 reference molecules, reflecting their growing adoption. Additionally, the FDA's Center for Biologics Evaluation and Research reported approving 17 new biologics and 26 supplements in 2024, showcasing strong regulatory support and a thriving development pipeline. High Capital Investment and Operational Costs Establishing and operating a compliant biopharmaceutical manufacturing facility in the United States involves considerable financial outlay. Building state-of-the-art infrastructure with advanced equipment, controlled environments, and stringent quality control systems leads to high initial capital expenses. Ongoing costs, including energy consumption, maintenance, skilled labor, and regulatory compliance, further intensify the financial pressure. Contract manufacturers must meet cGMP and other regulatory standards, requiring continuous investment in validation and training to avoid penalties, product recalls, or operational disruptions. These financial demands pose a major challenge, especially for organizations aiming to scale rapidly. Adoption of Single-Use Technologies Single-use technologies (SUTs) are increasingly being embraced in the U.S. biopharmaceutical contract manufacturing landscape for their benefits in flexibility, cost-effectiveness, and scalability. These systems - comprising disposable bioreactors, filters, and chromatography devices - help minimize contamination risks and eliminate complex cleaning requirements, thus streamlining operations. This is especially critical for CMOs handling multiple client projects and products. The growing use of SUTs reduces downtime and accelerates production timelines, which is particularly beneficial in manufacturing biologics like monoclonal antibodies, vaccines, and gene therapies where speed and compliance are essential. Report Scope Key Market Players: Lonza Group Ltd. WuXi Biologics Co., Ltd. Boehringer Ingelheim International GmbH Thermo Fisher Scientific Inc. Rentschler Biopharma SE JRS PHARMA GmbH & Co. KG AGC Biologics ProBioGen AG Samsung Biologics FUJIFILM Diosynth Biotechnologies United States Biopharmaceuticals Contract Manufacturing Market, By Source: Mammalian Non-mammalian United States Biopharmaceuticals Contract Manufacturing Market, By Service: Process Development Fill & Finish Operations Analytical & QC Studies Packaging & Labelling Others United States Biopharmaceuticals Contract Manufacturing Market, By Product: Biologics Biosimilars United States Biopharmaceuticals Contract Manufacturing Market, By Therapeutic Area: Oncology Autoimmune Diseases Infectious Diseases Cardiovascular Diseases Metabolic Diseases Neurology Others United States Biopharmaceuticals Contract Manufacturing Market, By Region: North-East Mid-West West South Key Attributes: Report Attribute Details No. of Pages 85 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $10.58 Billion Forecasted Market Value (USD) by 2030 $19.52 Billion Compound Annual Growth Rate 10.7% Regions Covered United States For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment U.S. Biopharmaceuticals Contract Manufacturing Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
