Latest news with #ANVISA
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Business Standard
6 days ago
- Business
- Business Standard
Here's why Natco Pharma share price is buzzing in trade on Thursday, May 29
Natco Pharma share price: Pharmaceutical company Natco Pharma share price rose as much as 6.66 per cent to hit an intraday high of ₹919.90 per share. However, by 12:01 PM, Natco Pharma share price was off day's high, and was trading 2.48 per cent higher at ₹883.80 per share. In comparison, BSE Sensex was trading flat with a negative bias at 81,287.30 level. Why did Natco Pharma share price rise in trade today? Natco Pharma share price rose on the back of a healthy March quarter of financial year 2025 (Q4FY25) results. The pharma company's consolidated profit after tax (PAT) rose to ₹406 crore in the March quarter of FY25, from ₹386.3 crore in the March quarter of FY24. At the operating level, earnings before interest, tax, depreciation and amortisation (Ebitda) soared to ₹614.4 crore in the March quarter of FY25, from ₹539.3 crore in the March quarter of FY24. However, Ebitda margin squeezed to 47.7 per cent in Q4FY25, from 48.6 per cent a year ago. About Natco Pharma Natco Pharma is a Hyderabad-based pharmaceutical company engaged in the development, manufacturing, and distribution of both generic and branded drugs. The company also operates in the specialty pharmaceutical and crop protection segments. Known for its strong focus on research and development, the company is a science-driven organisation with a leadership position in oncology, particularly in targeted therapies within the Indian market. In the United States, it concentrates on launching complex and limited-competition molecules. The company operates nine manufacturing facilities and two research and development (R&D) centres across India. Its production sites are accredited by major global regulatory agencies, including the US FDA, Brazil's ANVISA, Health Canada, and the World Health Organization (WHO), among others. Through its extensive compliance and quality framework, Natco Pharma serves over 50 international markets, reinforcing its global footprint in the pharmaceutical sector.
Business Standard
20-05-2025
- Business
- Business Standard
Wanbury's Patalganga facility receives GMP certification from ANVISA
Wanbury announced that its active pharmaceutical ingredient (API) manufacturing facility at Patalganga has successfully received the Certificate of Good Manufacturing Practices (CBPF) from ANVISA, the Brazilian Health Regulatory Agency. Earlier this month, on 12 May 2025, the company had also received GMP approval from ANVISA for its Tanuku site in Andhra Pradesh. The certification for the Patalganga site follows ANVISAs review of the inspection report of U.S. FDA, along with other documents submitted by the company. Based on the evaluation, ANVISA granted the GMP certification, confirming the facilitys compliance with Brazilian regulatory standards. With this certificate, now both the API manufacturing sites of Wanbury continue to be compliant per ANVISA' s rules & regulations. Wanbury is a pharmaceutical company with a presence in the global API market and domestic branded formulations. The company's consolidated net profit declined 88.12% to Rs 1.22 crore as revenues fell by 8.28% to Rs 133.45 crore in Q3 FY25 as compared with Q3 FY24. The counter declined 1.74% to Rs 299.35 on the BSE.
Business Upturn
12-05-2025
- Business
- Business Upturn
Wanbury's Tanuku facility in Andhra Pradesh completes ANVISA inspection with zero observations
Wanbury Limited announced the successful completion of an inspection by the Brazilian Health Regulatory Agency (ANVISA) at its manufacturing facility in Tanuku, Andhra Pradesh. The inspection was conducted from December 16 to December 20, 2024. According to Wanbury, the inspection concluded with zero observations, indicating full compliance with ANVISA's regulatory standards. The facility was evaluated for adherence to Current Good Manufacturing Practices (cGMP), which are required for pharmaceutical manufacturing. Advertisement Following the inspection, ANVISA granted the Good Manufacturing Practices (GMP) Certificate to the Tanuku facility. The Certificate of Good Manufacturing Practices (Certificado de Boas Práticas de Fabricação – CBPF) has been issued in both English and Portuguese. This certification is necessary for the export of pharmaceutical products to Brazil and demonstrates the facility's compliance with Brazilian regulatory requirements.
Yahoo
08-05-2025
- Business
- Yahoo
Overture Life's DaVitri Automated Fertility Preservation Platform Adds Brazil Regulatory Clearance
Latest market authorization supports the safety and effectiveness of DaVitri for consistent, high-quality vitrification PALO ALTO, Calif., May 08, 2025--(BUSINESS WIRE)--Overture Life, the innovator modernizing IVF to optimize reproductive freedom, announces the launch of its DaVitri platform for fertility preservation for Brazil's in vitro fertilization (IVF) clinics after being cleared for commercial use as a class I medical device by the nation's National Health Surveillance Agency (ANVISA). This latest marketing authorization makes Brazil the sixth country in South and Central America where DaVitri can be used to automate vitrification, following another recent launch in Peru. Embryologists in the two countries now join counterparts in Panama, Chile, Dominican Republic, and Argentina in improving the quality and consistency of the delicate vitrification steps, using DaVitri to help standardize processes and, ultimately, reduce the number of IVF cycles required to have a healthy baby. "We thank the regulators at ANVISA for their thorough review of DaVitri's technical, performance, and safety data," said Hans Gangeskar, CEO of Overture Life. "ANVISA's reputation for stringent review not only offers assurance to those in Brazil seeking to utilize IVF, but further supports our belief that widespread use of the automated DaVitri device will usher in a new era for quality, accessible reproductive healthcare." Overture's mission is to develop and deploy cutting-edge technology to bring the largely manual, outdated approaches common in IVF into the modern era. This includes the use of AI, automation, metabolomics, and microfluidics to ensure that prospective mothers can access the same high-quality fertility care regardless of income, geography, or insurance status. In particular, the tabletop DaVitri could eventually enable vitrification at a specialist's office, making IVF easier to access anywhere in the world. "We have been using the DaVitri system since June 2024 to automate vitrification. It increases our efficiency and makes our work more reproducible and safer for patients and physicians," said Dr. Jorge Castillo Baso, a specialist in gynecology and obstetrics and a founding partner of Ferticlinic and Fertidonors in Panama. "It improves the consistency of results and eliminates variability caused by human intervention, where errors can occur. It also frees up our embryologists' workload, allowing Ferticlinic to perform more procedures without compromising quality." About Overture Life Overture Life integrates engineering, reproductive medicine, and regulatory-grade validation to modernize embryology lab procedures, particularly fertility preservation and embryo handling, in ways that lower repeated cycles, increase throughput, and reduce the overall cost of IVF. With R&D in Spain and active U.S. operations, including a CLIA-licensed laboratory for non-invasive embryo selection, Overture unites robotics, analytics, and clinical rigor to deliver tools that clinics and patients can trust. The company's DaVitri platform aims to boost reliability and consistency in IVF, giving women and families worldwide more control over their fertility timelines. Overture's backers include Overwater Ventures, GV (formerly Google Ventures), Khosla Ventures, Octopus Ventures and others committed to advancing the future of fertility. View source version on Contacts Media Contact overture@
Business Upturn
06-05-2025
- Business
- Business Upturn
Vantage Hemp Co. Submits Application for Brazil Market Entry
By GlobeNewswire Published on May 6, 2025, 16:00 IST Greeley, Colorado, May 06, 2025 (GLOBE NEWSWIRE) — Vantage Hemp Co. ('Vantage' or 'the Company'), a globally accredited cannabinoid extractor and manufacturer, has initiated its regulatory process with ANVISA , Brazil's National Health Surveillance Agency, securing protocol numbers for its application of market authorization under the RDC 327/2019 framework and Good Manufacturing Practices Certification (CBPF) . This marks the formal start of Vantage's regulatory engagement with Brazil and lays the foundation for the Company's broader push into Latin America. Through a joint application with a Brazilian partner, Vantage has applied for approval for its initial formulation under RDC 327/2019. The bridge framework sets out rigorous requirements for the manufacturing, importation, and commercialization of cannabinoid-based products before pharmaceutical registration becomes feasible. This unique opportunity allows companies to apply for a license without having mandatory clinical studies which are often a major hurdle in the commercialization of pharmaceutical products. Vantage is positioned to meet the needs of the aspiring Brazilian market, which demands stringent pharmaceutical-grade manufacturing and full transparency across all production processes. Under the framework, companies must obtain Sanitary Authorization for each product, valid for five years, and adhere to strict quality and safety standards, including THC content limitations and mandatory physician prescriptions. As the largest healthcare market in Latin America and ranking sixth worldwide for drugs and pharmaceuticals , Brazil offers significant growth potential for cannabinoid-based therapies. As a mandatory step for compliant market entry, Vantage is pursuing CBPF certification from ANVISA, a requirement for manufacturing, importing, or distributing health-related products in Brazil. Backed by global compliance credentials such as WHO GMP, ICH Q7, and TGA PIC/S, Vantage is well-equipped to meet Brazil's regulatory standards, solidifying its role as a trusted, capable partner in the country's healthcare sector. 'Brazil represents an opportunity to support a large patient population. As a manufacturer, our goal is to empower companies in the region by providing compliant, scalable solutions,' says Deepank Utkhede, Chief Operating Officer at Vantage. 'While some companies avoid or exit international markets due to compliance hurdles, we're doubling down on our global expansion strategy, and we're committed to doing it right.' Following the receipt of protocol numbers, Vantage awaits ANVISA's review and scheduling of a site audit. The Company continues to invest in regional market readiness and client partnerships, confident that its regulatory-first approach will translate to long-term commercial success. Companies looking to register cannabinoid products in Brazil under RDC 327/2019 are encouraged to contact Vantage for manufacturing and regulatory partnership opportunities. About Vantage Hemp Co. Colorado-based Vantage Hemp Co. extracts and processes cannabinoids from industrial hemp, as well as formulates and manufactures finished products with the extracted ingredients. Vantage's contract manufacturing services offer a broad range of benefits as they operate with integrity and abide by stringent pharmaceutical production standards to provide quality products to their partners. For more information, visit . Attachment Vantage Hemp Co. Manufacturing Facility Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
