Latest news with #COFEPRIS
Mint
a day ago
- Business
- Mint
Indian drugmakers aim to boost exports to Mexico, South America's No. 2 pharma market
New Delhi: Indian drugmakers are in talks with Mexico for a simpler approval process as they seek to boost exports to the second-largest pharma market in South America, said two people aware of the matter. The Indian Drugs Manufacturers Association (IDMA) is intensifying its focus on Mexico, betting that the nation's complex drug approval process will be simplified, the people said on the condition of anonymity. Members of the association are in talks with officials from Mexico's ministry of economy and health regulator COFEPRIS (Federal Commission for the Protection against Sanitary Risks) to explore new rules and financial incentives, the people said. India seeks to significantly boost its medicine exports to Mexico, a market currently valued at over $20 billion and is expected to grow to $38.5 billion by 2033, according to a report by the International Market Analysis Research and Consulting Group. Domestic pharmaceuticals account for only $180 million. Indian drugmakers encounter challenges, primarily the lengthy and intricate regulatory hurdles set by COFEPRIS. India's pharmaceutical industry, the world's third largest by volume, is a global powerhouse with a diverse product base including generic drugs, vaccines, and biologics. In the fiscal year 2023-24, the market was valued at $50 billion, with exports accounting for $26.5 billion, according to the estimates provided by the Department of pharmaceuticals. Queries emailed to the Embassy of Mexico in New Delhi remained unanswered. "IDMA regularly participates in interactions with National Regulatory Agencies from various geographies," said Dr. Viranchi Shah, national spokesperson for IDMA. The talks reflect Mexico's increasing recognition of India as a reliable supplier of high-quality, affordable medicines. This push is part of a broader effort to strengthen the overall trade relationship between the two countries. While India's exports to Mexico have been growing, largely driven by the automobile and auto parts sectors, the pharmaceutical industry remains an underexplored avenue. Indian drug companies are keen to leverage Mexico's proximity to the US and its network of trade agreements to use it as a base for expanding into North and Central American markets. While a recent virtual meeting was postponed, an official familiar with the matter said IDMA is in contact with Mexican authorities to resolve the issues. This follows a similar meeting held a few months ago, indicating a consistent dialogue to streamline processes for Indian drug manufacturers. Mexico's pharmaceutical market, the second largest in Latin Americaafter Brazil and growth is fuelled by an ageing population and a rising prevalence of chronic diseases. For Indian companies, which are global leaders in generic drug production, a simplified regulatory path in Mexico could unlock a major new export corridor and diversify their international presence.
Yahoo
24-03-2025
- Business
- Yahoo
InstantGMP PRO™ Now Available in Spanish, Expanding Compliance Solutions for Global Manufacturers
CARY, N.C., March 24, 2025 /PRNewswire/ -- InstantGMP™, a leading provider of electronic batch record (EBR), manufacturing execution system (MES), quality management system (QMS), and GMP compliance software for regulated industries, is excited to announce that its flagship software, InstantGMP PRO™, is now available in Spanish. Following the recent launch of a Spanish-language translation of the InstantGMP website, this major development will enable pharmaceutical, dietary supplement, and cannabis manufacturers in Spain, Mexico, and Latin America to streamline their compliance efforts with digital solutions tailored to their language needs. With the increasing demand for advanced manufacturing solutions that meet global regulatory requirements, the availability of InstantGMP PRO™ in Spanish ensures that manufacturers can efficiently manage Registro de Producción de Lote (Batch Records), optimize Gestión de Calidad (Quality Management), and improve Gestión de Inventario (Inventory) through an intuitive, all-in-one system. Compliance with Good Manufacturing Practices (GMP) is essential for pharmaceutical and dietary supplement manufacturers worldwide. In Spain, manufacturers must adhere to EudraLex Volume 4 and AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) regulations, while in Mexico, COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) enforces GMP guidelines such as NOM-164 for pharmaceutical products and NOM-248 for dietary supplements. With InstantGMP PRO™ now available in Spanish, companies in these regions can enhance compliance processes, reduce errors, and improve operational efficiency by utilizing automated workflows. The cloud-based software's comprehensive features support manufacturers in maintaining regulatory compliance while simplifying documentation and production management. "Expanding InstantGMP PRO™ to Spanish-speaking users reinforces our commitment to making compliance more accessible for manufacturers worldwide," said Dr. Richard Soltero, President of InstantGMP. "By offering our industry-leading software in Spanish, we are equipping manufacturers in Spain, Mexico, and Latin America with the tools they need to enhance efficiency, meet GMP standards, and compete in the global market." Key Features of InstantGMP PRO™ in Spanish: Registro de Producción de Lote (Batch Records): Electronic batch record creation and management ensures data accuracy, compliance, and traceability. Gestión de Calidad (Quality Management): Automated workflows streamline compliance documentation and reduce the risk of errors. Gestión de Inventario (Inventory): Real-time inventory tracking and control to optimize production efficiency. Cloud-Based Access: Secure, real-time data accessibility from anywhere, enabling seamless remote operations. Paperless Compliance: Eliminate manual paperwork while adhering to FDA, EMA, and COFEPRIS regulations. By providing InstantGMP PRO™ in Spanish, InstantGMP is ensuring that regulated manufacturers in Spanish-speaking markets have the tools they need to modernize their production processes, maintain compliance, and drive business growth. To see InstantGMP PRO™ in action and learn how it can support your compliance efforts, contact our sales team today to schedule a demonstration. About InstantGMP™, Inc. Founded by pharmaceutical industry veteran Dr. Richard Soltero, InstantGMP, Inc., offers affordable all-in-one manufacturing, inventory and quality software. The company develops cloud-based electronic batch record software and standard operating procedures specific to industries that are required to follow FDA manufacturing regulations and Good Manufacturing Practices ("GMP"). As a manufacturing software company, InstantGMP™ pioneered accessible, easy-to-use electronic batch record software for products manufactured using GMPs. The Company's updated software simplifies the documentation and approval procedures for quality processes that keep all quality documentation organized in electronic format while providing for quality checks and workflow processes to make compliance with FDA requirements easy. Media Contact: Cory Pensacpensa@ View original content to download multimedia: SOURCE InstantGMP, Inc. Sign in to access your portfolio
Yahoo
03-03-2025
- Health
- Yahoo
Global Nasal Sprays Market Poised for Significant Growth, Expected to Reach USD 28,345.5 Million by 2035 grow at a CAGR of 6.0%
A nasal spray is a device used for nasal drug delivery in the nasal cavities. They are used to treat conditions, such as allergic rhinitis, cold, asthma, and central nervous system disorders. The device consists of drug substances in the form of a solution of excipients. NEWARK, Del, March 03, 2025 (GLOBE NEWSWIRE) -- The global nasal sprays market is set for substantial expansion, projected to grow from USD 15,819.0 million in 2025 to USD 28,345.5 million by 2035, registering a CAGR of 6.0% during the forecast period. Nasal sprays have gained widespread adoption due to their fast-acting drug delivery through the nasal passages, providing immediate relief for various conditions. Traditionally used for respiratory disorders such as allergic rhinitis and sinusitis, the market is experiencing further expansion as companies leverage nasal spray technology for non-respiratory treatments, creating new revenue streams. The rising prevalence of respiratory diseases remains a primary driver of market growth. Additionally, the increasing preference for over-the-counter (OTC) nasal sprays to manage minor allergic conditions is boosting demand. Access Key Market Insights: Request a Sample Report Now! What are the Factors Restraining Demand Within the Market? Throughout the projection period, a number of negative nasal spray effects are anticipated to impede market expansion. Nasal spray can cause itching, redness, and swelling in the nose, which might restrict its use and hamper the market growth. Another potential issue restricting market expansion is anticipated to be regulatory barriers brought on by strict drug sales regulations in nations like Russia and Mexico. For instance, Mexico's regulatory body, COFEPRIS, recently released new regulations for allowing the registration of generic pharmaceuticals, which exclude patents for novel therapeutic uses from its linkage system. Growing cardiovascular health risks, nasal irritation, and nasal congestion are other variables impeding market expansion during the evaluation period. Exploring Market Dynamics and Growth Avenues in the Nasal Sprays Industry Dominance of Nasal Steroid Sprays: Among product types, nasal steroid sprays continue to lead market growth due to their effectiveness in treating inflammation and allergies. Aqueous Formulation Leading the Market: The aqueous formulation is the most widely used, attributed to its safety, ease of application, and patient preference. Expansion into Non-Respiratory Treatments: With pharmaceutical companies exploring nasal drug delivery for broader therapeutic applications, the market is witnessing diversification and innovation, further fueling its expansion. As self-care and OTC medication adoption increase, the nasal sprays market is set to witness sustained growth, making it a lucrative segment in the global pharmaceutical industry. Expanding Market for Nasal Sprays Amid Growing Consumer Preference Nasal sprays have become a preferred mode of drug delivery for conditions such as allergic rhinitis, sinusitis, and nasal congestion. Their ability to provide direct action, faster absorption, and ease of use has fueled their popularity among patients and healthcare professionals. The market expansion is further supported by the rise in air pollution, increasing seasonal allergies, and the growing elderly population, which is more susceptible to respiratory ailments. Decongestant Sprays: The First Line of Defense Decongestant sprays, primarily containing oxymetazoline, phenylephrine, and xylometazoline, work by constricting blood vessels in the nasal passages, leading to quick relief from congestion. These sprays are widely used for short-term relief from colds, flu, and sinus the Market Landscape and Future Potential of Decongestant Sprays The availability of over-the-counter (OTC) decongestant sprays continues to drive market expansion. Increased awareness regarding the rebound congestion effect (rhinitis medicamentosa) is influencing consumer behavior, leading to controlled and regulated usage. Pharmaceutical companies are focusing on formulation advancements, including preservative-free and pH-balanced solutions, to enhance product safety and Demand for Market Data: Our Full Report Offers Deep Insights and Trend Analysis! Nasal Steroid Sprays: Long-Term Relief for Chronic Conditions Nasal steroid sprays, such as fluticasone, budesonide, and mometasone, are widely prescribed for long-term management of allergic rhinitis and chronic sinusitis. These sprays reduce inflammation, providing sustained relief without causing immediate vasoconstriction. Market Evolution and Future Pathways for Nasal Steroid Sprays Rising cases of allergic rhinitis and chronic sinusitis are fueling demand for steroid-based nasal sprays. Pharmaceutical companies are developing combination therapies (e.g., steroid + antihistamine sprays) to enhance treatment efficacy. The shift toward prescription-based nasal steroid sprays with improved safety profiles is driving regulatory approvals and new product launches. Significant Developments in the Nasal Sprays Market United States is expected to grow at a 4.4% CAGR from 2025 to 2035. Canada is projected to experience a 5.8% CAGR over the same period. Germany is set to witness a 4.3% CAGR between 2025 and 2035. France is forecasted to see a strong growth rate of 7.0% CAGR. Italy is anticipated to achieve the highest growth among the listed countries, with a 7.1% CAGR. United Kingdom is expected to expand at a 6.7% CAGR from 2025 to Insights Why is the Demand for Nasal Steroid Spray Continually Growing? Based on product sales, nasal steroid sprays are the most popular and are anticipated to hold a market share of 45.1% in 2023 nasal steroid sprays have the largest market share among all product categories in the world. In order to treat nasal allergy symptoms like sneezing and runny nose, nasal steroid sprays inject a corticosteroid directly into the nose. These sprays can relieve hay fever or nasal allergies, and they frequently take the place of other oral allergy treatments. To continue to feel better during allergy season, one must use them every day. The category is anticipated to maintain its high market share during the forecast period due to the commercialization of affordable generics of nasal steroid spray and its convenient availability throughout Europe countries. What Makes the Aqueous Formulation the Most Popular? The aqueous formulation is anticipated to hold 53.3% of the market share in 2023 in terms of formulation. The aqueous formulation is anticipated to dominate the nasal spray market for the projected period. Aqueous formulation administers medications either locally or systemically through the nose. They are applied locally to treat conditions like allergic rhinitis and nasal congestion, as it offers a good option for injection or pill. Hence, the aqueous formulation is used more than hydroalcoholic, or nonaqueous-based solution, suspension, or emulsion systems. Which Packaging Material is used in Mostly Global Nasal Spray Markets? Polymer packaging material is expected to dominate the packaging material segment with 88.3% of the global market in 2023. The barrier qualities of polymers are advantageous because they prolong shelf life, keep products clean, and prevent contamination. Less wear is also largely owed to the low frictional characteristics. Packaging made of polymers is often lighter, which lowers the manufacturer's transportation costs. While glass packaging uses a lot of energy. This occurs as a result of the high temperature needed for manufacturing processing, hence the use of polymers is high. Why are Nasal Pump Bottles Sales Gaining Traction? Pump bottles in the packaging category are expected to account for 73.8% of the overall market share in 2023. The pump bottles' superior dosing accuracy is responsible for their dominance in the market. Since pressurized sprays are difficult to use with high-viscosity solutions, the product is becoming more popular. As a result, the market is expected to grow quickly now and over the next ten years. Nasal pump bottles are easy to use and can be easily available hence the use of nasal pump bottles is increasing. What is the Contribution of Institutional Sales to Developing the Global Nasal Spray Market? The report predicts that throughout the projected period, the institutional sales segment would dominate the worldwide nasal spray market. In terms of distribution channels, the institutional sales sector is expected to hold 56.4% of the overall market share in 2023. The rising cost of healthcare and strong sales of generic drugs are responsible for the segment's dominance. Institutional sales dominate because most physicians prescribe nasal spray to treat people experiencing allergic symptoms like colds, congestion, sneezing, and runny noses are on the rise. Competitive Landscape of the Nasal Sprays Market The nasal sprays market is witnessing intense competition as companies focus on developing innovative formulations for various therapeutic applications, including allergy relief, pain management, and opioid overdose treatment. Strategic partnerships and collaborations are increasingly shaping the industry, particularly in the commercialization of life-saving treatments such as naloxone sprays for opioid reversal. The launch of new nasal sprays for anaphylaxis treatment is further intensifying competition, as companies strive to capture market share across both consumer and healthcare sectors. Innovation in drug formulations, advanced delivery systems, and regulatory approvals remain key factors influencing market dynamics. Key Players in the Nasal Sprays Market Becton Dickinson & Company GlaxoSmithKline Novartis AG (Sandoz) AstraZeneca Pfizer Inc. Bayer AG Merck & Co., Inc. Sanofi Boehringer Ingelheim International GmbH Viatris Inc. (Mylan N.V.) Future-Proof Your Healthcare Business with Our Reports! Looking Ahead: The Future of the Nasal Sprays Market By 2035, the nasal sprays market is expected to witness strong growth, driven by research innovations, personalized medicine, and the rise of digital health solutions. With increasing investments in drug-device combination products, manufacturers are working toward enhanced delivery mechanisms, such as breath-actuated nasal sprays and nanoparticle-based formulations. Furthermore, the adoption of telemedicine and e-pharmacies will make nasal sprays more accessible, expanding their reach in developing regions. Regulatory advancements and consumer education campaigns will play a crucial role in ensuring safe and effective use. The future of the nasal sprays market, particularly for decongestant and nasal steroid sprays, looks promising. As healthcare innovation progresses, patients will benefit from safer, more effective, and personalized nasal spray solutions. With strategic investments in R&D and patient awareness, the industry is set to evolve, making nasal sprays a vital component of respiratory care. Nasal Sprays Market Segmentation By Product: In terms of product, the industry is segmented into decongestant sprays, nasal steroid sprays, nasal antihistamine sprays, nasal cromolyn sodium sprays, nasal anticholinergic sprays, nasal triamcinolone sprays, and others. By Formulation: In terms of formulation, the industry is bifurcated into Aqueous, Hydroalcoholic, Non-acqueous based solutions, suspensions, emulsions, and dry powder/microparticles. By Packaging: In terms of packaging, the industry is segmented into pressurized canisters and pump bottles. By Dosage: In terms of dosage, the industry is bifurcated into multi dose, bi dose, and single/unit dose. By Distribution Channel: In terms of distribution channel, the industry is segmented into Institutional Sales (hospitals, community clinics, specialty clinics, and public health agencies) and retail sales (retail pharmacies, drug stores, and mail order pharmacy). By Region: Key countries of North America, Latin America, Western Europe, Eastern Europe, South Asia and Pacific, East Asia, the Middle East, and Africa have been covered in the report. Explore FMI's Related Ongoing Coverage on Healthcare Domain: According to Future Market Insights research, during the projected period, the global migraine nasal spray market size is expected to grow at a CAGR of 7.0%. The market value is projected to increase from USD 501.1 million in 2023 to USD 983.5 million by 2033. Future Market Insights has mentioned in its reports that the steroid-free nasal sprays market share is estimated to be USD 8,577.5 million in 2023, will expand at a CAGR of 6.4% between 2023 and 2033, totaling around USD 15,908.1 million by 2033. The global inhalation and nasal spray generic drugs market demand is projected to have a moderate-paced CAGR of 8.96% during the forecast period. The current valuation of the inhalation and nasal spray generic drugs market is USD 20.78 Billion in 2023. The value of the inhalation and nasal spray generic drugs market is anticipated to reach a high of USD 49.01 by the year 2033. The global nasal packing devices market growth is expected to reach a market valuation of USD 189.4 million by 2023, accelerating with a moderate CAGR of 5.1% from 2023 to 2033. The nasal packing devices market size is anticipated to be valued at about USD 311.9 million by 2033 end. By 2023, the nasal antihistamines market trends is projected to attain a value of around USD 2.06 billion, with an expected CAGR of 4.6%. Sales of nasal antihistamines are anticipated to reach a noteworthy USD 3.23 billion by 2033 potentially. The global nasal allergy treatment market outlook is set to experience substantial expansion, with market value projected to increase from USD 6.6 billion in 2022 to an estimated USD 13.3 billion by 2033, reflecting a CAGR of 6.7% from 2023 to 2033. Expected to be valued at USD 4.6 billion by the end of 2023, the sales of nasal polyposis treatment is likely to expand at a CAGR of 6.7% until 2033. By the conclusion of the 2023-2033 forecast period, a valuation of USD 8.8 billion is anticipate for nasal polyposis treatment. According to Future Market Insights research, during the projected period, the global intranasal corticosteroids market overview is expected to grow at a CAGR of 5.0%. The market value is projected to increase from USD 6.8 Billion in 2023 to USD 11.2 Billion by 2033. The high flow nasal cannula market forecast is expected to witness a decline, with the market projected to decrease from USD 1,369.3 million in 2024 to USD 1,063.0 million by 2034. The market is further anticipated to experience a downturn, with a CAGR of -2.5% during the forecast period 2024 to 2034. According to Future Market Insights research, during the projected period, the global fragmentable nasal and ear dressing market analysis is expected to grow at a CAGR of 6.5%. The market value is projected to increase from USD 585.8 Million in 2023 to USD 1.1 Billion by 2033. The fragmentable nasal and ear dressing market was valued at USD 550.2 Million at the end of 2022 and is anticipated to exhibit Y-o-Y growth of 6.2% in 2023. About Future Market Insights (FMI) Future Market Insights, Inc. (ESOMAR certified, recipient of the Stevie Award, and a member of the Greater New York Chamber of Commerce) offers profound insights into the driving factors that are boosting demand in the market. FMI stands as the leading global provider of market intelligence, advisory services, consulting, and events for the Packaging, Food and Beverage, Consumer Technology, Healthcare, Industrial, and Chemicals markets. With a vast team of over 400 analysts worldwide, FMI provides global, regional, and local expertise on diverse domains and industry trends across more than 110 countries. Join us as we commemorate 10 years of delivering trusted market insights. Reflecting on a decade of achievements, we continue to lead with integrity, innovation, and expertise. Contact Us: Future Market Insights Corporate, 200 Continental Drive,Suite 401, Newark, Delaware - 19713, USAT: +1-347-918-3531For Sales Enquiries: sales@ Twitter| Blogs | YouTube
