Latest news with #ActivePharmaceuticalIngredients
Time of India
17-05-2025
- Business
- Time of India
Dr Reddy's receives two USFDA observations for New York API facility
Dr Reddy's Laboratories announced on Saturday that the United States Food and Drug Administration ( USFDA ) has issued a Form 483 with two observations following an inspection of its API (Active Pharmaceutical Ingredients) manufacturing facility in Middleburgh, New York. In a regulatory filing, the Hyderabad-based pharmaceutical company stated that the GMP (Good Manufacturing Practice) inspection was carried out between May 12 and May 16, 2025, news agency PTI reported. 'At the conclusion of the inspection, we received a Form 483 with two observations, which we will address within the stipulated timeline,' the company said. According to the USFDA, a Form 483 is issued when inspectors identify conditions that may potentially violate the Food, Drug, and Cosmetic (FD&C) Act or related regulations. The observations are shared with a firm's management to prompt corrective action. On May 16, Dr Reddy's Laboratories Ltd closed at Rs 1,228.50, marking a decline of Rs 7.80 or 0.63% from the previous trading session. Earlier on Friday, Dr Reddy's Laboratories had reported a 21 per cent year-on-year increase in consolidated net profit to Rs 1,587 crore for the quarter ended March 2025, driven by strong sales across key markets such as the US and India. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Avoid Emotional Trades in Volatile Markets – Master Swing with Hemant TradeWise Learn More Undo The Hyderabad-based pharmaceutical company had recorded a net profit of Rs 1,307 crore in the same quarter of the previous year. Revenue for the January–March quarter had risen to Rs 8,506 crore, compared to Rs 7,083 crore a year earlier, according to a regulatory filing. For the full financial year 2024–25, Dr Reddy's had posted a net profit of Rs 5,724 crore, marking a modest 3 per cent growth over the Rs 5,568 crore reported in FY24. The company's annual revenue had increased to Rs 32,553 crore from Rs 27,916 crore in the preceding fiscal. India's Pharma sector India's pharmaceutical industry , a major supplier to the United States, is likely to come under increasing pressure amid heightened regulatory scrutiny. In FY24, the US accounted for $8.7 billion of India's total pharma exports of $27.9 billion, according to the Pharmaceuticals Export Promotion Council of India. More than 45% of the generic drugs used in the US are manufactured in India, underscoring the country's crucial role in the American healthcare system, according to an ET report. Additionally, Indian firms supply approximately 15% of the biosimilars consumed in the US. Leading companies such as Sun Pharma, Dr Reddy's, Aurobindo Pharma, Zydus Lifesciences, and Gland Pharma generate up to half of their revenues from the US market, making them particularly sensitive to regulatory developments. Stay informed with the latest business news, updates on bank holidays and public holidays . AI Masterclass for Students. Upskill Young Ones Today!– Join Now
Yahoo
13-05-2025
- Business
- Yahoo
Saudi Arabia Active Pharmaceutical Ingredients Market Forecasts & Opportunities Report 2024-2025 & 2030 Featuring Pfizer, Aurobindo Pharma, Novartis, BASF, Viatris, and Novo Nordisk
The Active Pharmaceutical Ingredients (API) market in Saudi Arabia is a critical segment of the country's pharmaceutical industry, which is experiencing notable expansion. This growth is fueled by rising healthcare needs, substantial government investment, and a shift toward enhancing local manufacturing capabilities. As one of the largest pharmaceutical markets in the Middle East, Saudi Arabia is integral to the regional API supply chain, both as a consumer and a producer. Saudi Arabian Active Pharmaceutical Ingredients Market Dublin, May 13, 2025 (GLOBE NEWSWIRE) -- The "Saudi Arabia Active Pharmaceutical Ingredients Market, By Region, Competition, Forecast & Opportunities, 2020-2030F" report has been added to Saudi Arabia Active Pharmaceutical Ingredients Market was valued at USD 290.75 Million in 2024, and is expected to reach USD 417.62 Million by 2030, rising at a CAGR of 6.18%. The demand for APIs is driven by the increasing prevalence of chronic diseases such as diabetes, cardiovascular conditions, and cancer, which necessitate both essential and specialized pharmaceutical products. Additionally, the growing adoption of generic drugs is stimulating API production, as generics typically rely on more cost-effective active ingredients compared to branded drugs. This trend is further supported by government policies that encourage the use of generics to reduce healthcare costs and improve access to medications. The regulatory landscape, overseen by the Saudi Food and Drug Authority (SFDA), ensures that all APIs meet international standards of quality, safety, and efficacy. The SFDA's rigorous regulations foster a controlled and high-quality manufacturing environment, which is essential for long-term market stability and Market Drivers Rising Healthcare Demand and Disease PrevalenceRising healthcare demand and increasing disease prevalence are critical factors driving the growth of the Active Pharmaceutical Ingredients (API) market in Saudi Arabia. As the Kingdom experiences significant demographic changes and the healthcare needs of its population grow, the demand for APIs is expanding in tandem. These factors create a pressing need for pharmaceuticals to address the rising incidence of chronic diseases, thus spurring a substantial market for both essential and specialized APIs. Saudi Arabia's population is steadily increasing, alongside a marked rise in life expectancy. With a growing and aging population, the demand for healthcare services is Initiatives and Policy SupportGovernment initiatives and policy support play a pivotal role in driving the growth of the Active Pharmaceutical Ingredients (API) market in Saudi Arabia. Saudi Arabia's Vision 2030 places a strong emphasis on healthcare workforce development to build a sustainable healthcare National Transformation Program, a critical component of Vision 2030, directly supports the pharmaceutical sector by improving healthcare services and fostering innovation. The NTP includes goals for enhancing healthcare access, improving the quality of medical treatments, and expanding the capacity for drug production within the Saudi Food and Drug Authority (SFDA) plays a crucial role in regulating the pharmaceutical sector, ensuring that all products, including APIs, meet international quality and safety standards. In recent years, the SFDA has made significant strides in streamlining regulatory processes to facilitate the entry of new players into the API market. These reforms are designed to ensure efficiency, reduce bureaucratic hurdles, and create an environment conducive to Toward Generic MedicinesThe shift toward generic medicines is a significant driver of growth in the Saudi Arabian Active Pharmaceutical Ingredients (API) market. This shift is reshaping the pharmaceutical landscape in the Kingdom, creating increased demand for high-quality, cost-effective APIs that form the backbone of generic drug production. Several factors are contributing to this transition, including government policies, cost-saving measures, and the evolving preferences of healthcare providers and consumers. Generic medicines are widely recognized for their cost-effectiveness compared to branded growing demand for generics translates directly into a higher need for APIs, as these drugs rely heavily on active ingredients that are less expensive than their branded counterparts. As the Saudi healthcare system increasingly prioritizes affordability and access, the demand for APIs to produce generics continues to grow. The Saudi government has been a strong proponent of increasing the use of generic drugs in the Kingdom as part of its broader healthcare reform agenda. Policies designed to enhance access to affordable medicines have encouraged the use of generics, both in the public and private Market Challenges Dependence on Imported Raw Materials and TechnologyOne of the most significant challenges facing the Saudi Arabian API market is the heavy reliance on imported raw materials and technology. While the Kingdom has made strides in promoting local pharmaceutical manufacturing, a large portion of the active ingredients used in the production of both branded and generic medicines is still imported from countries like India, China, and Europe. This dependency on foreign suppliers creates vulnerabilities in the supply chain, including fluctuations in raw material prices, geopolitical risks, and issues related to international and Compliance ChallengesThe Saudi Arabian pharmaceutical industry, including the API market, is subject to stringent regulatory frameworks governed by the Saudi Food and Drug Authority (SFDA). While these regulations are designed to ensure safety, efficacy, and quality, they can also pose significant challenges to API manufacturers. The regulatory requirements for API production are complex and often involve lengthy approval processes, particularly for new products or for generics that are being introduced to the issue is the harmonization of Saudi regulations with international standards. While Saudi Arabia is increasingly aligning its pharmaceutical regulations with global best practices, differences between local and international regulatory requirements can lead to delays and additional costs for API producers, especially those who wish to export their products. Regulatory complexity, coupled with a lack of clear guidance in some areas, continues to be a significant barrier to the growth of the Saudi API Market Trends Increased Focus on Biotechnology and BiopharmaceuticalsOne of the most prominent trends influencing the future of the Saudi Arabian API market is the growing emphasis on biotechnology and biopharmaceuticals. With advancements in biologics and biosimilars, the pharmaceutical industry is experiencing a shift from traditional small-molecule drugs to more complex biologic treatments. These biologic drugs, which include monoclonal antibodies, recombinant proteins, and gene therapies, rely on specialized APIs that require advanced manufacturing processes and cutting-edge Saudi Arabia moves towards improving its healthcare system and expanding access to modern treatments, the demand for biologic drugs is anticipated to rise. This trend is already visible in the increasing focus on cancer therapies, autoimmune disease treatments, and personalized medicine, all of which heavily rely on biologic APIs. The Saudi government's efforts to boost local pharmaceutical manufacturing, combined with its push to foster biotechnology and innovation, will create a favorable environment for the growth of biopharmaceutical API production in the Kingdom. Adoption of Advanced Manufacturing Technologies (Industry 4.0)The integration of advanced manufacturing technologies, often referred to as Industry 4.0, is another trend expected to drive the future growth of the Saudi API market. Industry 4.0 encompasses the use of automation, artificial intelligence (AI), machine learning, the Internet of Things (IoT), and big data analytics to optimize manufacturing processes, enhance quality control, and reduce operational Industry 4.0 technologies enable the production of more complex APIs, such as those required for biologics and high-potency drugs, further enhancing the Kingdom's ability to meet growing demand for advanced pharmaceutical products. Key Attributes: Report Attribute Details No. of Pages 80 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $290.75 Million Forecasted Market Value (USD) by 2030 $417.62 Million Compound Annual Growth Rate 6.1% Regions Covered Saudi Arabia Key Topics Covered: 1. Service Overview1.1. Market Definition1.2. Scope of the Market1.2.1. Markets Covered1.2.2. Years Considered for Study1.2.3. Key Market Segmentations2. Research Methodology2.1. Objective of the Study2.2. Baseline Methodology2.3. Key Industry Partners2.4. Major Association and Secondary Sources2.5. Forecasting Methodology2.6. Data Triangulation & Validation2.7. Assumptions and Limitations3. Executive Summary3.1. Overview of the Market3.2. Overview of Key Market Segmentations3.3. Overview of Key Market Players3.4. Overview of Key Regions/Countries3.5. Overview of Market Drivers, Challenges, Trends4. Voice of Customer5. Saudi Arabia Active Pharmaceutical Ingredients Market Outlook5.1. Market Size & Forecast5.1.1. By Value5.2. Market Share & Forecast5.2.1. By Type of Synthesis (Synthetic, Biotech, Monoclonal Antibodies, Recombinant Proteins, Vaccines, Hormones, Cytokines, Therapeutic Enzymes, Blood Factors)5.2.2. By Type of Manufacturer (Captive APIs, Merchant APIs, Biotech Merchant APIs, Synthetic Merchant APIs)5.2.3. By Type (Generic APIs, Innovative APIs)5.2.4. By Application (Cardiovascular Diseases, Oncology, CNS and Neurology, Orthopedic, Endocrinology, Pulmonology, Gastroenterology, Nephrology, Ophthalmology, Others)5.2.5. By Type of Drugs (Prescription, OTC)5.2.6. By Region5.2.7. By Company (2024)5.3. Market Map6. Eastern Saudi Arabia Active Pharmaceutical Ingredients Market Outlook6.1. Market Size & Forecast6.1.1. By Value6.2. Market Share & Forecast6.2.1. By Type of Synthesis6.2.2. By Type of Manufacturer6.2.3. By Type6.2.4. By Application6.2.5. By Type of Drugs7. Western Saudi Arabia Active Pharmaceutical Ingredients Market Outlook8. Northern & Central Saudi Arabia Active Pharmaceutical Ingredients Market Outlook9. Southern Saudi Arabia Active Pharmaceutical Ingredients Market Outlook10. Market Dynamics10.1. Drivers10.2. Challenges11. Market Trends & Developments11.1. Recent Developments11.2. Product Launches11.3. Mergers & Acquisitions12. Saudi Arabia Active Pharmaceutical Ingredients Market: SWOT Analysis13. Competitive Landscape Pfizer Scientific Technical Limited Company Aurobindo Pharma Limited Novartis AG BASF Saudi Arabia Co. Ltd. Viatris Inc Novo Nordisk Saudi Arabia 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 Saudi Arabian Active Pharmaceutical Ingredients 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 +353-1-416-8900
Mint
04-05-2025
- Business
- Mint
325% rally in five years! Multibagger pharma stock in focus; here's why
Multibagger stock: Pharma company Sudarshan Pharma Industries share price will remain in focus in Monday's trading session after the company reported its half yearly and FY25 financial & operational performance on Friday. The multibagger pharma stock was down 1.99 per cent to close at ₹ 26.66 apiece on May 2. Sudarshan Pharma Industries shares have given mutlibagger returns to its investors by soaring over 325 per cent in five years. In the second half of FY25 (H2FY25), Sudarshan Pharma Industries Limited (SPIL) reported a 19% rise in net sales to ₹ 277 crore and a 43% increase in net profit to ₹ 7 crore compared to H2FY24. For the full fiscal year FY25, net sales rose by 9% to ₹ 505 crore, while net profit surged by 45% to ₹ 16 crore year-on-year. The company, currently valued at ₹ 642 crore in market capitalization, has achieved a strong compound annual profit growth of 37% over the past five years. SPIL is actively working to boost its exports and increase domestic sales of its manufactured medicines, the pharma company said in its investor's presentation. Additionally, it aims to improve profit margins from reselling Active Pharmaceutical Ingredients (API) in India. This strategic focus contributed to a significant rise in EBITDA margin in H2FY25, which in turn drove strong growth in Profit After Tax during the same period. India's pharmaceutical industry was valued at approximately $42 billion in 2021 and is projected to rise to around $50 billion by 2024. Forecasts suggest it could reach nearly $66 billion by 2025 and potentially expand to between $120 billion and $130 billion by 2030. India fulfills 40% of the United States' generic drug requirements and supplies 25% of the medicines used in the United Kingdom. Globally, India contributes 20% of total medicine production by volume and meets about 60% of the world's vaccine demand, solidifying its position as the leading supplier of generic drugs. Founded in 2008, Sudarshan Pharma is engaged in manufacturing and sourcing of Chemicals and Pharmaceutical products. The Company specializes in host of products from rock chemicals intermediates and API to finish formulations and fully integrated pharmaceutical and chemicals. Disclaimer: This story is for educational purposes only. The views and recommendations above are those of individual analysts or broking companies, not Mint. We advise investors to check with certified experts before making any investment decisions. First Published: 4 May 2025, 01:51 PM IST
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First Post
28-04-2025
- Business
- First Post
Water, medicines, fertiliser: Pakistan in panic mode as India tightens screws after Pahalgam attack
India's suspension of the Indus Waters Treaty, halt of all trade and ban on pharmaceutical supplies following the Pahalgam terror attack has triggered panic in Pakistan. With critical sectors like farming and healthcare under threat, Pakistani authorities are scrambling to find alternative supply sources. read more The decision by India to suspend the World Bank-mediated Indus Waters Treaty of 1960 — which ensures water for 80% of Pakistani farms — halt all trade and ban pharmaceutical supplies in response to the Pahalgam terror attack that killed 26 people last week, has panicked Pakistan, prompting it to initiate emergency measures, including approaching other countries for supplies and seeking mediation to ease tensions. The move has escalated tensions between the two countries. India has closed the Attari-Wagah border, effectively putting on hold cross-border trade worth Rs 3,886.53 crore between India and Pakistan. STORY CONTINUES BELOW THIS AD According to a media report, Pakistani health authorities have initiated 'emergency preparedness' measures to secure pharmaceutical supplies in response to the suspension of trade ties with India. 'Following the 2019 crisis, we had started preparing for such contingencies. We are now actively looking at alternative avenues to meet our pharmaceutical needs,' the report quoted a senior Drug Regulatory Authority of Pakistan (DRAP) official as saying. Although direct trade between India and Pakistan remains limited, goods worth nearly $10 billion reach Pakistan through indirect channels every year, according to estimates by the Global Trade Research Initiative (GTRI). Currently, Pakistan relies on India for 30% to 40% of its pharmaceutical raw materials, including Active Pharmaceutical Ingredients (API) and various advanced therapeutic products. With this supply chain disrupted, DRAP is now seeking alternative sources from China, Russia, and several European countries. 'We'll die of hunger' Spraying pesticides on his parched vegetables one street away from the Indus River, Pakistani farmer Homla Thakhur is worried about his future. The sun is at its peak, the river is running very low, and India has vowed to cut supplies upstream after the deadly militant attack in Kashmir. 'If they stop water, all of this will turn into the Thar desert, the whole country,' said Thakhur, 40, before heading back to the river to refill the tank for the spray gun. 'We'll die of hunger.' His nearly 5-acre (2-hectare) farm is located in the Latifabad area of the southeastern province of Sindh, from where the Indus flows into the Arabian Sea after originating in Tibet and snaking through India. STORY CONTINUES BELOW THIS AD Thakhur's fears were echoed by more than 15 Pakistani farmers and several other experts, especially as rainfall has been scant in recent years. For the first time, India on Wednesday suspended the Indus Waters Treaty, saying it would last until 'Pakistan credibly and irrevocably abjures its support for cross-border terrorism'. With inputs from agencies.
News18
27-04-2025
- Health
- News18
Pakistan Takes 'Emergency' Steps To Secure Drug Supplies After India Halts Trade: Report
Agency: PTI Pakistan currently relies on India for 30% to 40% of its pharmaceutical raw materials, including Active Pharmaceutical Ingredients (API) and various advanced therapeutic products. Pakistani health authorities have initiated 'emergency preparedness" measures to secure pharmaceutical supplies in response to the suspension of trade ties with India, according to a media report on Saturday. In response to the India's decision to suspend the Indus Water Treaty following the Pahalgam attack, Islamabad on Thursday suspended all trade with New Delhi among other moves. Geo News reported that India's trade halt triggered 'urgent measures to secure" pharmaceutical needs in Pakistan, and health authorities have initiated 'emergency preparedness" measures to secure the supplies. The Drug Regulatory Authority of Pakistan (DRAP) has confirmed that while there has been no formal notification regarding the ban's impact on the pharmaceutical sector, contingency plans are already in place, it said. 'Following the 2019 crisis, we had started preparing for such contingencies. We are now actively looking at alternative avenues to meet our pharmaceutical needs," the report quoted a senior DRAP official as saying. Currently, Pakistan relies on India for 30% to 40% of its pharmaceutical raw materials, including Active Pharmaceutical Ingredients (API) and various advanced therapeutic products. With this supply chain distributed, DRAP is seeking alternative sources from China, Russia, and several European countries. The agency aims to ensure the continuous availability of essential medical supplies, including anti-rabies vaccines, anti-snake venom, cancer therapies, monoclonal antibodies, and other critical biological products. 'Pakistan imports some 30%–40% of its pharmaceutical raw material from India. We also import finished products, most importantly, anti-cancer therapies, biological products, vaccines, and sera, especially anti-rabies vaccine and anti-snake venom from India," a senior official from the Ministry of National Health Services, Regulations and Coordination said, requesting anonymity. The Ministry of Health has yet to receive an official directive clarifying the status of pharmaceutical imports, despite the government's blanket announcement suspending all trade with India. The pharmaceutical sector fears that disruption in the supply chain could lead to critical shortages. The situation is further complicated by the existence of a robust black market, where unregistered and unapproved medicines are smuggled into Pakistan through Afghanistan, Iran, Dubai, and even across the eastern border, the report said. While these channels fill gaps left by legal imports, they offer no guarantee of quality or consistent supply. A delegation of pharmaceutical industry leaders travelled to Islamabad on Thursday to appeal for an exemption from the trade ban. 'We had meetings with DRAP and Ministry of Commerce officials to discuss the suspension of trade ties. We urged them to exempt the pharmaceutical sector from the ban, as there are many life-saving products whose raw materials come exclusively from India," said Tauqeer-ul-Haq, Chairman of the Pakistan Pharmaceutical Manufacturers Association (PPMA). The PPMA delegation also approached the Special Investment Facilitation Council (SIFC), arguing that pharmaceutical and health-related trade must be excluded from the ban to protect patients' lives. However, some experts see the current crisis as a wake-up call for long-term investment in local production of APIs, vaccines, and biologicals. 'This crisis could be a turning point for Pakistan," said Zafar Iqbal, a senior public health expert. Terrorists opened fire in Jammu and Kashmir's Pahalgam on Tuesday, killing 26 people, mostly tourists, in the deadliest attack in the Valley since the Pulwama strike in 2019. The Resistance Front (TRF), a proxy of the banned Pakistan-based Lashkar-e-Taiba (LeT), claimed responsibility for the attack. First Published:
