Latest news with #FDA-inspected
Business Wire
7 days ago
- Business
- Business Wire
Bora Pharmaceuticals Announces Multi-Year Expansion for Midwest Manufacturing Site, as Upsher-Smith Entity Split is Finalized
MAPLE GROVE, Minn.--(BUSINESS WIRE)-- Bora Pharmaceuticals Co., Ltd. ('Bora' or 'the Company', TWSE: 6472), a global leader in pharmaceutical manufacturing, has announced plans for significant investments to expand its manufacturing and packaging capabilities at its facility in Maple Grove, Minnesota. This is a major upgrade to the site, which Bora acquired in 2024 as part of its $210 million acquisition of Upsher-Smith Laboratories, expanding its U.S. manufacturing footprint. 'Bora's Maple Grove facility offers a unique opportunity for large pharmaceutical innovators to secure space in a state-of-the-art site staffed by experts in formulation development, tech transfer, and commercial manufacturing,' said J.D. Mowery. As the entity separation from Upsher-Smith Laboratories takes effect on August 5, Bora continues its growth amid surging demand for oral solid dose (OSD) development and manufacturing brought on by increasingly complex formulations, novel drug delivery technologies, and the growing shift of biologics into OSD formats. Bora has already secured multiple multi-million-dollar contracts for development and commercial supply of advanced OSD programs. 'With pharmaceutical companies relying more heavily on specialized CDMO partners to scale production and maintain quality, top-tier manufacturing capacity and technical expertise are at a premium,' said J.D. Mowery, president of Bora's CDMO business. 'Bora's Maple Grove facility offers a unique opportunity for innovators to secure space in a state-of-the-art site staffed by experts in formulation development, tech transfer, and commercial manufacturing.' The first phase of Bora's investment will add a Gerteis Macro-Pactor® at the company's state-of-the-art site. This investment initiates a broader buildout of 100,000 square feet of dedicated shell space designed to streamline production for partners with high-volume needs. The Gerteis Macro-Pactor® roller compactor will be installed and operational in the third quarter of 2025. 'As we complete our transition from Upsher-Smith, we're creating the infrastructure to deliver integrated manufacturing, packaging, and analytical services with the speed and quality our clients need,' shared Dennis Hall, Vice President and General Manager of the Maple Grove site. 'As we expand our capabilities, we look forward to tapping into all the experience and talent in the area.' The facility offers on-site quality control laboratories and a dedicated development team to support product and analytical development as well as innovation. It is an FDA-inspected manufacturing site and meets global health authority requirements, ensuring regulatory compliance. From early development and scale-up to process optimization and commercial manufacturing, Bora's experienced teams support customers at every stage of the product lifecycle. The company's commercial on-time, in-full (OTIF) delivery record is unmatched, reinforcing Bora's role as a trusted partner, supporting clients with secure, consistent supply. For more information, visit About Bora Pharmaceuticals Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. For more information, visit
The Hill
17-07-2025
- Business
- The Hill
FDA reverses ban on sale of Juul e-cigarettes
The Food and Drug Administration has authorized Juul Labs to keep its e-cigarettes on the market, a major reversal after the agency completely banned the company's products in 2022. The agency said Thursday it will allow the sale of Juul's original e-cigarette device as well as refill cartridges in tobacco and menthol flavors. The move followed 'an extensive scientific review' that showed the benefit to adult smokers outweighed the risk to young people or adults who don't smoke. FDA said Juul submitted evidence showing high rates of adults completely switched from cigarettes to either the tobacco- or menthol-flavored Juul products. 'While today's actions permit these specific e-cigarette products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they FDA approved,' the agency said. FDA's decision marks the latest chapter for a company so popular it was once synonymous with vaping. But as more young people began using its fruit and candy-flavored products, federal scrutiny grew. Juul has denied allegations that it marketed its e-cigarettes to children and teens. The FDA in 2022 announced a ban on the sale of Juul e-cigarettes nationwide, saying the company did not prove that keeping its products on the market 'would be appropriate for the protection of the public health.' The agency suspended the order about two weeks later to conduct an internal review of 'scientific issues' in the company's application. Despite the pause, FDA's actions nearly bankrupted the company. It also subsequently paid $1.7 million billion to resolve thousands of lawsuits alleging the company aggressively marketed its e-cigarettes to young people and fueled a vaping crisis. The FDA considered Juul's appeal for two years and in 2024 formally rescinded the ban, putting the company's application back under scientific review. All electronic cigarette products are required by law to have FDA authorization to be legally marketed, and the companies must submit scientific evidence of public health benefits. 'Today's FDA authorization of JUUL products marks an important step toward making the cigarette obsolete,' K.C. Crosthwaite, Juul Labs' CEO said in a statement. 'We strongly support FDA's role in regulating tobacco and nicotine products,' Crosthwaite continued. 'Americans who use nicotine deserve an orderly, reliable market in which they can confidently choose from a wide array of smokefree nicotine products that are high-quality, innovative, backed by rigorous research, made in FDA-inspected manufacturing facilities, and marketed and sold responsibly.' Still, Juul is no longer the juggernaut it once was and has lost significant market share amid rising competition, including from e-cigarettes illegally imported from China. But anti-tobacco groups said they were dismayed by FDA's decision, saying it risks a reversal of recent progress in reducing youth e-cigarette use. 'It is a big step in the wrong direction to authorize sales of the product that was responsible for this public health crisis in the first place,' said Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids. 'There is no question that this crisis was driven by Juul's sleek, easy-to-hide products, which were sold in enticing flavors, including menthol, were marketed in ways that appeal to kids and delivered massive doses of nicotine that can quickly addict kids,' Richardson added. The American Lung Association (ALA) similarly blamed Juul for the spike in youth vaping. 'This is a serious misstep,' Ranjana Caple, senior manager of federal advocacy for ALA said in a statement. 'Juul is responsible for the youth vaping epidemic, and its products have hooked a generation of kids on nicotine. Authorizing these products signal a stunning failure to protect public health.'
Business Insider
16-07-2025
- Business
- Business Insider
AptarGroup acquires Mod3 Pharma's clinical trial manufacturing capabilities
Aptar Pharma (ATR) announced it has acquired the clinical trial materials manufacturing capabilities of Mod3 Pharma from SWK Holdings (SWKH). The acquisition enhances Aptar's support for early-stage drug development by providing formulation, fill and finish services for Phase 1 and 2 clinical trials. Through the deal, Aptar Pharma will operate an FDA-inspected facility in Boonton, New Jersey, with an initial focus on orally inhaled nasal drug products. Financial terms were not disclosed. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Business Wire
15-07-2025
- Business
- Business Wire
Aptar Pharma Bolsters Clinical Trial Capabilities with Strategic Materials Manufacturing Acquisition
CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Aptar Pharma, a global leader in drug delivery and active material science solutions and services, today announces its acquisition of the clinical trial materials manufacturing capabilities of Mod3 Pharma (formerly Enteris Biopharma) from SWK Holdings. This strategic move strengthens Aptar's support for early-stage drug development by offering formulation, fill and finish services for Phase 1 and 2 clinical trials and enhances adoption of its proprietary devices in early-stage clinical programs. This acquisition builds on a successful collaboration between Aptar Pharma and Mod3 Pharma, particularly in serving Aptar Pharma customers with Phase 1 and Phase 2 cGMP fill and finish services for orally inhaled nasal drug products (OINDPs), filling a largely unmet need in the market. The capabilities acquired also help Aptar address a growing market demand for agile, high-quality Current Good Manufacturing Practices (cGMP) clinical trial material supply services that complement the segment's existing service offerings. Additionally, the acquisition accelerates the adoption of new drug delivery technologies, initially focusing on OINDPs, with potential expansion into dermal, ophthalmic, injectable and secondary packaging solutions using Aptar's Active Material Science Solutions. Aptar Pharma will now operate an FDA-inspected, state-of-the-art facility in Boonton, New Jersey. The site includes cGMP cleanrooms, high-potency Active Pharmaceutical Ingredient (API) suites, biologics capabilities, and advanced fill-finish technologies - fully aligned with Aptar Pharma's drug delivery solutions portfolio. Gael Touya, President of Aptar Pharma, commented, 'Our vision at Aptar Pharma is clear: From formulation to patient. By integrating Phase 1 and 2 clinical manufacturing capabilities, we're not just expanding our technical footprint - we're deepening our commitment to customers seeking a seamless and accelerated path to market. This move reinforces our position as a trusted partner from molecule to delivery, and ultimately, to the patient.' Sai Shankar, President, M&A, Strategy, Business Development, Marketing, Drug Services, added, 'We're expanding our niche services to help customers move faster in areas of unmet need, and without duplicating the strengths of our trusted partners. This strategic expansion of our services builds on our legacy in drug dosing and dispensing systems by integrating deeper expertise as a drug delivery innovator, as well as product development and formulation, allowing us to offer more specialized and holistic support to our customers.' Dr. Paul Shields, CEO of Mod3 Pharma, remarked, 'We are delighted to become part of the Aptar family. This acquisition reflects our shared commitment of accelerating the development of innovative therapies and bringing them to patients faster.' About Aptar Pharma Aptar Pharma is part of AptarGroup, Inc. (NYSE:ATR), a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions. Aptar's innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home, food and beverage. Using insights, proprietary design, engineering and science to create dispensing, dosing and protective technologies for many of the world's leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has 13,000 dedicated employees in 20 countries. For more information, visit
Yahoo
14-07-2025
- Health
- Yahoo
Legal Steroid Alternatives for Muscle Growth 2025: CrazyBulk Introduces Effective Legal Steroid Alternatives For Bulking, Cutting, Fat Loss, and Strength in USA
CrazyBulkNew York City, NY, July 11, 2025 (GLOBE NEWSWIRE) -- CrazyBulk, a leading provider of legal steroid alternatives, is excited to announce its expanded line of top-rated, natural supplements designed to help athletes and fitness enthusiasts build muscle, enhance strength, and lose fat. These cutting-edge products are formulated to provide safe, effective results, mimicking the effects of anabolic steroids without the associated side effects and legal risks. In a world where the pursuit of peak performance and aesthetic goals often leads people to seek illegal and dangerous steroid options, CrazyBulk offers a powerful and legal alternative that is both safe and effective. By using scientifically-backed, natural ingredients, CrazyBulk's Legal steroid alternatives for muscle growth can help individuals achieve their fitness goals while maintaining their overall health and well-being. The Science Behind CrazyBulk's Legal Steroid Alternatives For Muscle Growth: CrazyBulk's products are developed using natural ingredients that have been proven to work effectively. Key ingredients such as beta-hydroxy-beta-methylbutyrate (HMB), D-Aspartic Acid, and Tribulus Terrestris have been studied for their role in enhancing muscle retention, boosting testosterone, and supporting fat loss. These ingredients mimic the effects of anabolic steroids while ensuring the safety of the user. Beta-Hydroxy-Beta-Methylbutyrate (HMB): Known for its muscle-preserving properties, HMB helps prevent muscle loss, especially during cutting phases. D-Aspartic Acid: A powerful amino acid that helps increase testosterone production, promoting muscle growth and strength. Tribulus Terrestris: A plant extract used to naturally enhance libido and support testosterone levels, improving overall fitness performance. Why Choose CrazyBulk's Legal Steroid Alternatives? No Harmful Side Effects: These products are designed to deliver the benefits of anabolic steroids without the negative health implications. Natural, Effective Ingredients: Each product features ingredients like beta-hydroxy-beta-methylbutyrate (HMB), D-Aspartic Acid, and Tribulus Terrestris, which are widely recognized for their ability to support muscle building, fat loss, and overall physical performance. Designed for Real Results: CrazyBulk's supplements are backed by real-world results from customers who have achieved their fitness goals without compromising their health. How to Choose Legal Steroid Alternatives For Muscle Growth? Unlike traditional anabolic steroids, which can cause serious health issues such as liver damage, increased risk of heart disease, hormonal imbalances, and behavioral changes, CrazyBulk's legal steroid alternatives are specifically designed to help individuals gain muscle, burn fat, and improve strength safely. CrazyBulk supplements are manufactured in FDA-inspected, GMP-certified facilities to ensure the highest quality and safety. Key Features of CrazyBulk's Legal Steroid Alternatives: Legal and Safe Alternatives: No need for dangerous anabolic steroids or risky injections. CrazyBulk's supplements are made with natural ingredients that mimic the effects of steroids without harmful side effects. Improved Performance: These supplements are scientifically formulated to enhance strength, stamina, and endurance, helping users push through their workouts and break through fitness plateaus. Rapid Muscle Growth: By increasing nitrogen retention and protein synthesis, CrazyBulk products stimulate rapid muscle gains without the water retention commonly associated with traditional steroids. Fat Loss: Many of these products also promote fat-burning, allowing users to achieve a leaner physique while preserving muscle mass. Natural Ingredients: Every product is carefully crafted using natural, research-backed ingredients, ensuring that users can enhance their performance and physique without compromising their health. Clinically Researched: While individual results can vary, the key ingredients used in CrazyBulk products have been shown to support muscle growth, fat loss, and improved physical performance. Product Range and Highlights: D-Bal (Alternative to Dianabol): Supports rapid muscle growth and strength. Enhances nitrogen retention, which aids muscle recovery and growth. Helps users experience maximum strength during intense training sessions. 2. Testo-Max (Alternative to Sustanon 250): Naturally increases testosterone production, which boosts strength and muscle mass. Increases energy and stamina for better performance during workouts. Supports faster muscle recovery and enhanced overall performance. 3. Tren-Max (Alternative to Trenbolone): Helps burn fat while maintaining lean muscle mass. Perfect for cutting cycles, helping users achieve a shredded physique. Increases energy levels and endurance during workouts. 4. Anvarol (Alternative to Anavar): Supports fat loss while preserving lean muscle tissue. Ideal for cutting cycles and increasing vascularity. Boosts strength and endurance, allowing for more intense training sessions. 5. Clenbutrol (Alternative to Clenbuterol): Promotes fat burning by increasing metabolism and energy levels. Enhances performance and improves aerobic capacity. Helps users maintain a lean physique without losing muscle mass. Each of these products is crafted with a unique blend of ingredients that have been carefully selected for their ability to naturally support muscle growth, fat loss, and strength enhancement. Whether you're looking to bulk up, cut fat, or improve your performance, CrazyBulk's offer a Best legal steroid alternatives safe and effective Steroid Alternatives For Muscle Growth by CrazyBulk Safe and Effective Ingredients: CrazyBulk supplements contain ingredients such as beta-hydroxy-beta-methylbutyrate (HMB), D-Aspartic Acid, Tribulus Terrestris, and many more, all known for their ability to support muscle growth, fat loss, and overall physical performance. These ingredients are backed by clinical studies and have been shown to produce results similar to those of traditional anabolic steroids, without the harmful side effects. Beta-Hydroxy-Beta-Methylbutyrate (HMB), for example, is widely recognized for its ability to promote lean muscle retention and fat loss, making it an excellent choice for those looking to maintain muscle mass while cutting body fat. Safety and Efficacy: Each CrazyBulk product is manufactured in FDA-inspected, GMP-certified facilities, ensuring the highest standards of quality and safety. Unlike synthetic steroids, which carry potential risks like liver damage, cardiovascular issues, and hormonal imbalances, CrazyBulk's alternatives offer a non-toxic, non-harmful approach to muscle building and fat loss. Unlike anabolic steroids, CrazyBulk products are designed with user safety in mind. The ingredients are non-toxic, and clinical studies have shown that they are just as effective as anabolic steroids in promoting muscle growth, fat loss, and strength, without the negative health consequences. Furthermore, CrazyBulk supplements do not require injections, and they are completely legal to purchase and use without a prescription. This makes them an ideal option for individuals who are serious about improving their performance without compromising their health or breaking the law. What Sets CrazyBulk Legal Steroid Alternatives Apart? Proven Results: CrazyBulk products are backed by customer testimonials, real-world results, and clinical research. 100% Natural Ingredients: CrazyBulk's supplements are made with natural, safe ingredients that are free from harmful chemicals and steroids. Customer Satisfaction: CrazyBulk is committed to customer satisfaction and offers a 100% money-back guarantee if customers are not satisfied with their products. Expert Formulations: The company's supplements are formulated by fitness experts and professionals, ensuring that each product delivers maximum effectiveness. About CrazyBulk Legal Steroid Alternatives For Muscle Growth: CrazyBulk is a leading supplement brand specializing in Best legal steroid alternatives designed to help athletes and fitness enthusiasts reach their muscle-building, fat-burning, and strength-enhancing goals. With a focus on natural ingredients and customer safety, CrazyBulk offers a wide range of products formulated to maximize workout performance without the risks associated with anabolic steroids. With a commitment to quality and excellence, CrazyBulk continues to be the trusted choice for individuals seeking to improve their fitness and achieve their physique goals. For more information about CrazyBulk's products, ingredients, and to make a purchase, please visit Company Name and Location Launch Date & Availability CrazyBulk's new line of legal steroid alternatives for muscle growth is available now, starting from April 29, 2025. These products can be purchased directly through the official CrazyBulk website at https::// With a wide range of options designed for muscle growth, fat loss, and strength enhancement, these science-backed, natural supplements are ready to help athletes and fitness enthusiasts achieve their goals safely and effectively. Scientific Data and Studies i CrazyBulk's legal steroid alternatives are formulated using scientifically proven ingredients supported by clinical studies. Key components like D-Aspartic Acid have been shown to increase testosterone production, improving muscle growth and strength. Beta-Hydroxy-Beta-Methylbutyrate (HMB) helps prevent muscle breakdown and supports fat loss, as demonstrated in numerous studies on muscle preservation during cutting cycles. Tribulus Terrestris has been linked to improved strength and enhanced performance. All ingredients are selected based on peer-reviewed research, ensuring that CrazyBulk products deliver the desired results without the adverse side effects of traditional anabolic steroids. Health & Safety Benefits of CrazyBulk's Legal Steroid Alternatives Safe and Natural: Made from 100% natural ingredients, offering a safer alternative to traditional anabolic steroids. No Harmful Side Effects: Unlike anabolic steroids, CrazyBulk's products do not cause liver damage, hormonal imbalances, or cardiovascular issues. Muscle Growth: Ingredients like D-Aspartic Acid boost testosterone production, supporting enhanced muscle growth and strength. Fat Loss & Muscle Retention: HMB helps preserve lean muscle while promoting fat loss, ideal for cutting cycles. Improved Recovery: Natural compounds accelerate recovery, reducing muscle soreness and allowing for more intense workouts. Energy & Performance Boost: Tribulus Terrestris and other ingredients increase stamina, endurance, and workout performance. Manufactured Safely: Produced in FDA-inspected, GMP-certified facilities to ensure top-quality standards and safety. Effective & Legal: Achieve your fitness goals legally and safely, with the same benefits of anabolic steroids, without the risks. Market Disruption by CrazyBulk's Legal Steroid Alternatives Safer Alternative to Traditional Steroids: CrazyBulk disrupts the market by providing a legal and safe alternative to anabolic steroids, which have well-known health risks. Natural Ingredients with Proven Effectiveness: By focusing on natural, research-backed ingredients, CrazyBulk challenges the reliance on synthetic substances and harmful chemicals in bodybuilding supplements. Convenient & Easy to Use: Unlike injectable steroids, CrazyBulk's supplements come in easy-to-take pill or capsule form, offering a hassle-free user experience. Cost-Effective: With no need for expensive medical treatments or prescriptions associated with steroids, CrazyBulk's products offer an affordable option for muscle growth and fat loss. Legality and Safety: CrazyBulk products are legally available and free from the legal and health concerns tied to anabolic steroid use, attracting a broader customer base. High-Quality Standards: Manufactured in FDA-inspected, GMP-certified facilities, CrazyBulk sets new industry standards for quality and safety. Consumer Benefits of CrazyBulk's Legal Steroid Alternatives Safe and Effective: Offers the muscle-building benefits of anabolic steroids without harmful side effects. Natural Ingredients: Made with scientifically proven, natural ingredients that enhance muscle growth, fat loss, and strength. Convenient Use: Available in easy-to-take pills or capsules, eliminating the need for injections. Boosts Performance: Increases strength, stamina, and endurance, leading to more effective workouts. Supports Fat Loss: Promotes fat burning while preserving lean muscle mass, ideal for cutting cycles. No Legal Issues: Fully legal and safe to use, without the risks of traditional steroids. High Quality: Manufactured in FDA-inspected, GMP-certified facilities to ensure product safety and efficacy. Distribution Channels Official CrazyBulk's Legal Steroid Alternatives Website Direct-to-Consumer Sales: Ensuring authenticity, best pricing, and support. Global Shipping: CrazyBulk's delivers to the USA, UK, Canada, Australia, and 130+ countries. No Third-Party Retailers: Only available online from the brand for guaranteed quality. Website URL & Contact Person Details Website: https::// Contact Email: support@ Customer Service: 24/7 live chat and email support available Safety Certifications and Testing FDA-Registered Facilities GMP-Certified Manufacturing ISO Quality Standards Third-Party Lab Testing for Purity and Potency Visit the Official CrazyBulk's website to learn more, read real reviews, and discover the science of Legal Steroid Alternatives Manufactured under the Technical Guidance of: Project name: Crazybulk Official Website: https::// 244 Madison Avenue, New York City, NY 10016-2817 Postal code: NY 10016-2817 Media Contact: Full Name - Neil Bowers email: support@ +1 888-708-6394 Contact Us for Advertising: Info@ Attachment CrazyBulk CONTACT: Project name: Crazybulk Official Website: https::// 244 Madison Avenue, New York City, NY 10016-2817 Postal code: NY 10016-2817 Media Contact: Full Name - Neil Bowers email: support@ +1 888-708-6394 Contact Us for Advertising: Info@ 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
