Phenylephrine Hydrochloride

New Delhi: In a relief to pharma companies, including Glenmark Pharmaceuticals and Zuventus Healthcare , the Delhi High Court on Thursday held that the government's April 15 notification that prohibited the manufacture, sale, and distribution of all fixed-dose combinations (certain cough syrup brands) for those below four years of age will apply prospectively. The notification issued by the Ministry of Health and Welfare , which came into effect immediately on the said date, mandated a manufacturer to include a warning stating ‘fixed-dose combination shall not be used in children below four years of age’ on the label and package insert or promotional literature of the drug. A Division Bench led by Chief Justice DK Upadhaya accepted the concerns of the manufacturers that the notification cannot applied retrospectively as some stocks have been manufactured and were in the market before the ban came into effect on April 15. However, the court asked the companies to issue an advisory to doctors, chemists and retailers that fixed dose combination of drugs shall not in “any circumstances” be prescribed/administered to children below four years of age. Additionally, the judges asked the manufacturers to publish an "unambiguously worded notice" in two national newspapers—one in English and one in Hindi— having nationwide circulation. The size of the notices must be designed to attract the attention of readers, the court said. The notice and advisory shall be published within a week, the court said. However, the manufacturers have been directed to “compulsorily comply” with the notification by mentioning the warning on all their labels and packaging of all stocks manufactured and circulated after April 15. The pharma companies must file an affidavit furnishing details of the stocks manufactured, sold or have been in circulation before April 15, the court said. However, the court clarified that any such public notice published by the pharma companies should not be construed as an advertisement and would not amount to any breach of their drug license conditions. If the pharma companies abide by the conditions regarding the notice, advisory, and undertakings, irrespective of the manufacture and sale of the drug in question, no coercive measures against them will be taken, the court. The court will hear the case for compliance on May 15. Senior counsel Amit Sibal and counsel Ajay Bhargava alleged that the drug manufacturers and other stakeholders were not given any opportunity of hearing before the notification was issued. The directions came on a couple of appeals filed by Glenmark and Zuventus challenging the validity of the April 15 notification issued by the Department of Health and Welfare that prohibited the use of all formulations of the fixed dose combination of chlorpheniramine maleate plus phenylephrine hydrochloride in children below four years of age. The restrictions issued under Section 26A of the Drugs and Cosmetics Act, 1940 were imposed on the recommendations of the Drugs Technical Advisory, citing safety concerns. The prohibited fixed drug combination is a commonly used formulation found in various over-the-counter drugs used to treat colds and allergies. The drugs, widely prescribed and sold under various brand names, include Ascoril Flu Drops and some variants of Alex by Glenmark Pharma. By Indu Bhan ,

Expanded Product Line Targets Growing Demand for Proactive Wellness Solutions in Clinics, Med Spas, 503A Pharmacies, and Telehealth Practices Across the United States WEST PALM BEACH, Fla. and EXTON, Pa., April 23, 2025 /PRNewswire/ -- ProRx Pharma, the leading health and wellness 503B outsourcing facility, today announced the addition of six new injectable products designed to support the rising demand for preventive care: Gonadorelin, Liraglutide, Vitamin D3, and Phenylephrine HCl as well as two Tri-Mix injection options. These high-quality standalone injectables are now available for bulk shipping to licensed medical facilities in 26 states and for direct-to-consumer shipping nationwide through ProRx's growing network of 503A pharmacies, clinics, med spas and telehealth providers. "Patients are taking charge of their health like never before," said Kurt Lunkwitz, chief operating officer at ProRx. "Physicians are following suit, integrating wellness therapies into their practices to meet the demand for more proactive, functional care. This trend is only going to continue. The continued expansion of our health and wellness line is a direct response—and a step toward making preventative health more accessible and streamlined." What's New: The Products Each of the six new offerings comes with its own National Drug Code (NDC) number and an extended Beyond Use Date (BUD), providing both flexibility and longer shelf life for providers: Gonadorelin ( 1 mg/mL, 6 mg / 6 mL vial ) A gonadotropin-releasing hormone agonist which is used in fertility medicine and to treat amenorrhea and hypogonadism. Gonadorelin may promote testosterone production; may support fertility, libido, and hormonal balance. Liraglutide ( 0.75 mg, 1 mg, 2 mg, 3 mg [custom dosing] ) A powerful GLP-1 receptor agonist for weight and blood-sugar management. Liraglutide may aid in weight loss, appetite suppression, and blood-sugar control. Vitamin D3 ( 50,000 IU/mL, 5 mL vial ) A high-dose solution for those with critically low vitamin D levels. Vitamin D3 may support immune function, bone health, mood, and Vitamin D repletion. Tri-Mix #1 ( 30 mg / 1 mg / 10 mcg/mL, 5 mL vial ) The first of two strength offerings for erectile dysfunction (ED) therapy. Tri Mix #1 may improve erectile response through smooth muscle relaxation and blood flow. Tri-Mix #2 ( 30 mg / 2 mg / 20 mcg/mL, 5 mL vial ) A stronger ED therapy offering. Tri-Mix #2, may provide more ED support for patients needing increased vasodilation. Phenylephrine HCl ( 0.1% 2 mL vial) A critical safety solution for patients using Tri-Mix therapies. Phenylephrine HCl may reverse prolonged erection or priapism due to ED therapy. The introduction of these six new products comes on the heels of ProRx announcing its first four preventative-care offerings the first week of April: Sermorelin, NAD+, Glutathione and MIC/B6/B12. Exclusive Launch at A4M Conference ProRx is showcasing its full line of preventative-care products at the A4M 33rd Annual Spring Conference taking place April 24-26 in West Palm Beach, Florida. At Booth 527, attendees will get an exclusive first look at all 10 products in the new product line and be able to speak with ProRx's experts about the company's compliance and quality-assurance programs. About ProRx Pharma ProRx Pharma is an FDA-registered cGMP facility focused on providing essential compounded medications to meet the need for medications on the FDA drug shortage and bulks list with an emphasis on preventative health. The company produces products and formulations for medical institutions, physician offices, and 503A pharmacies, with a specialization in producing high-quality products to ensure patients have access to the medications they need during critical shortages. For more information, visit SOURCE ProRx Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED