Latest news with #ANVISA


Forbes
03-07-2025
- Business
- Forbes
This Brazilian Startup Is Turning A Population Of 211 Million Into A Cannabis Data Goldmine
Toninho Corrêa While much of the world watches Germany and the U.S. inch forward on cannabis reform, Brazil has quietly become home to a fast-growing and highly structured medical cannabis market. And helping drive that transformation is a mobile app (not a clinic, cultivator or multinational) that's redefining patient access in one of the world's most complex regulatory environments. It's called Blis, and if you haven't heard of it yet, you're not alone. Built entirely in Brazil by a team of local developers and patients, the platform has already reached more than 300,000 users, generates R$2 million (about $363,000) in monthly revenue and holds what may be the largest real-world cannabis patient database in Latin America. With a population of more than 211 million, Brazil is Latin America's largest potential market for medical cannabis, but also one of the most complex to navigate. Under ANVISA's RDC 660 and RDC 327, cannabis prescriptions are legal, but only for imported, pharmaceutical-grade products, and only with doctor supervision. Despite those constraints, analysts project Brazil's medical cannabis sector could exceed $4.4 billion by 2032, driven by rising demand, decreasing stigma and a worsening mental health crisis. Across the region, Latin America's legal cannabis market is expected to reach $3.75 billion by 2028, with Brazil accounting for a significant share, especially if CBD flower is reauthorized for import in the coming months, opening an entirely new vertical for digital platforms. Born From Patients, Built For Brazil Blis didn't begin in a boardroom; it started with a group of Brazilian patients, frustrated by the painful logistics of getting medical cannabis legally. 'We faced enormous difficulties,' said CEO Toninho Corrêa. 'From the medical consultation to the import bureaucracy.' The existing system was slow, scattered and intimidating. So they built something new: an app approved by both Apple and Google that allows full legal access to cannabis treatment in Brazil, from doctor consultation to home delivery, in just a few taps. According to Corrêa, the platform has reduced access time by 160x, collapsing what used to take weeks into a seamless digital experience. And as cannabis adoption in Brazil shifts from critical conditions like Parkinson's and epilepsy toward broader wellness use (for sleep, anxiety, stress and focus), demand is accelerating. 'In practice, we are creating an entirely new market in Brazil for this type of alternative therapy,' he said. Rather than adapt a foreign model, Blis was built locally from the ground up, with Brazilian regulations, payment systems and patient behavior in mind. 'Importing a foreign model wouldn't work,' Corrêa said. 'We needed a solution tailored to the country's regulatory and cultural context.' That local-first approach has now positioned Blis as a scalable model for the rest of Latin America — and beyond. Numbers That Speak For Themselves In under a year, Blis has surpassed 300,000 downloads and now reaches patients in more than 1,800 cities and towns across Brazil, including many rural areas where medical support is limited or nonexistent. According to the company, over 60% of users who complete a consultation go on to purchase a product. Furthermore, the platform boasts a 42% repurchase rate, signaling strong adherence to treatment plans. Blis App The average order value is around R$1,000 (roughly $182) and the top-selling products are gummies and oils focused on sleep, anxiety and focus, an indicator of Brazil's shifting relationship with cannabis: less taboo, more therapeutic. 'Gummies grew faster than we expected,' Corrêa said, noting their popularity among women aged 30 to 45, who favor discreet, precisely dosed formats. Adoption is also rising among patients over 60, especially for sleep support and chronic pain relief; a demographic often overlooked in global cannabis marketing. 'We're not just seeing growth in the typical early adopter audience. This is mainstream,' he added. A Massive Cannabis Patient Dataset You've Probably Never Heard Of Beyond product sales, Blis is quietly building something even more valuable: data. With over 25,000 real-world patient records and growing, the platform now manages what it claims is one of the largest clinical cannabis databases in Latin America, a resource that could shape treatment standards, support clinical trials and inform regulatory strategy across the region. The company says all data collection follows strict LGPD standards and informed consent protocols. The top three conditions being treated on the platform are insomnia, anxiety and stress, a mental health trifecta that has surged across Brazil in the wake of COVID-19 and ongoing economic instability. Corrêa says the company is now exploring partnerships with researchers and institutions to translate this data into high-impact clinical insights. 'This is a living ecosystem. We're just getting started.' Blis says it handles patient data in full compliance with Brazil's General Data Protection Law (LGPD), using anonymization protocols for any internal studies or aggregated analysis. 'Only authorized professionals have access to patient records, with full traceability and consent controls,' Corrêa noted. While no personal data is currently shared with third parties, Blis may partner with research institutions in the future — but only under strict ethical review and legal safeguards. 'Patients are always informed about how their data is used and can revoke consent at any time,' Corrêa said. Corrêa also noted a sharp rise in interest for gummies, particularly among women and older patients, who value simplicity, discretion and routine. 'We were surprised by how fast that segment matured,' he said. It's a signal that, when designed well, medical cannabis can meet people where they are, without intimidation or stigma. A Market Shaped By Regulation — But Led By Patients From the outside, Brazil's medical cannabis landscape can look impenetrable. But insiders like Corrêa argue that perception no longer matches reality. 'Many still think cannabis is illegal or only accessible in very severe cases,' he said. 'But ANVISA's RDCs 660 and 327 allow legal access with a prescription. The real issue isn't regulation; it's public awareness and access.' In that gap, Blis has positioned itself as both a healthcare facilitator and an information bridge. The company has invested heavily in educational outreach, working with media outlets, conservative audiences and even older patient groups to dispel misconceptions and normalize treatment. 'We made a point of starting Blis' communication through more traditional channels,' Corrêa said. 'That helped us build credibility in places where cannabis was still taboo.' A potential turning point looms: the reauthorization of CBD flower imports, which ANVISA is reportedly considering in the coming weeks. If approved, it would open a new therapeutic category for platforms like Blis, allowing faster-acting, inhalable options for patients with chronic pain, advanced conditions or prior experience with cannabis. 'We're ready,' Corrêa said. 'This would expand our product portfolio and create new experiences for patients who need different kinds of relief.' From Patient App To Platform Play Blis may have started as a fix for a broken access system, but it's now eyeing a far larger opportunity. The company says it hit breakeven within six months, now counts over 25,000 active patients and projects a valuation of over $100 million by year's end, up from roughly $60 million today. The roadmap ahead includes expanding to at least one Latin American market by 2025, launching new technology and service channels, and publishing the company's first clinical data report based on its growing patient base. 'We're building toward a R$1 billion valuation by 2027,' Corrêa said, 'but more importantly, we're building trust.' To reach that next phase, Blis is currently in conversations with investors, strategic partners and scientific collaborators — both in Brazil and internationally. Corrêa says he's open to capital, but only when it aligns with the company's mission. 'What we're looking for is more than money. It's regulatory expertise, clinical insight and the ability to scale responsibly.' Latin America Is Watching Although Blis was built specifically for Brazil's regulatory maze, its model, combining technology, medical guidance and legally compliant distribution, could travel well. 'Blis was built to scale,' Corrêa said. 'Countries like Colombia, Argentina and Mexico are already advancing cannabis regulations, and we see a strong fit for digital platforms that educate and reduce stigma.' Each country brings its own challenges, but the demand patterns — anxiety, insomnia, chronic pain — are strikingly similar across Latin America. Corrêa believes Brazil's unique mix of tight regulations and huge unmet demand has forced innovation in a way that could serve as a template for emerging markets. 'Brazil may lag in public perception, but we lead in digital access,' he said. Compared to countries like Colombia, which has prioritized cultivation, or Mexico, where legal ambiguity continues to stall implementation, Brazil's patient-first approach, anchored in ANVISA oversight and doctor supervision, may prove more scalable in the long term. And while most of the international cannabis spotlight remains focused on North America and Europe, Corrêa is confident: 'The next wave of cannabis innovation may not come from where people expect.' Redefining Wellness, One Click At A Time For Corrêa, cannabis is just the beginning. 'Blis is not just a cannabis company: it's a new model of wellness for Latin America,' he said. The platform's long-term vision includes expanding into personalized protocols, new therapeutic categories, and broader public health integration, all grounded in real-world data and patient experience. As mental health needs grow and healthcare systems strain under demand, platforms like Blis are positioning themselves not just as dispensers of product, but as scalable infrastructure for care. 'The debate is no longer led by regulators,' Corrêa said. 'It's led by patients.' Blis may not have brand recognition in North America — yet — but its trajectory offers a glimpse of what cannabis innovation can look like when it's rooted in need, built with purpose, and shaped by the realities of the people it serves.


Business Standard
23-06-2025
- Business
- Business Standard
Alde Medi Hosts Groundbreaking 2025 Annual Meeting, Reinforces Commitment to Global Healthcare Innovation
India PR Distribution New Delhi [India], June 23: In a bold step towards redefining the future of healthcare marketing & manufacturing, Alde Medi Impex, a trusted name in the pharmaceutical world, hosted its 25th annual Business Conference 2025. The event brought together healthcare professionals, pharma leaders, and strategic partners under one roof to share insights, foster collaboration, and unveil what the future holds for Alde Medi and the broader healthcare landscape. Far beyond just a milestone, the conference reflected Alde Medi's growing role--not only as a manufacturer but as a driver of innovation, meaningful partnerships, and global trust in healthcare solutions. A Glimpse into the Future: Key Announcements at the Business Conference The energy at the conference was electric, and the announcements made reflected Alde Medi's forward-thinking approach to growth, quality, and innovation. Some of the standout moments included: * A 35% Surge in Domestic Growth Alde Medi recorded a strong 35% growth in India's domestic market driven by focused strategies, deep market understanding, and growing trust among hospitals, institutions, and healthcare providers. * Launching a New-Gen Sterile Injectables Facility Plans for a state-of-the-art sterile injectables facility were unveiled, scheduled for completion by December 2025. Designed to meet the most stringent global standards - EUROPE, SAUDI FDA, and ANVISA, this facility will raise the bar for quality, precision, and compliance in Indian pharma manufacturing. * ALDEVIT Gold Climbs to the Top ALDEVIT Gold, the company's flagship multivitamin, was recognised as India's 47th top brand among over 1,600 multivitamin products (as per IMS Health data). A proud achievement that reflects growing demand and credibility in the wellness segment. * Exports Skyrocket by 80% Alde's exports soared by 80% in 2024, marking a major leap in its global footprint. Now officially a Government Recognized Export House, Alde Medi has over 100 product registrations across 20+ countries and active exports in 35+ global markets with team size of more than 100 professionals contributing at different part of the world . The next big leap: entering Brazil and Mexico with plans to file 200+ new dossiers in 2025 in various countries. * Somediza Lifesciences: Generic Division Launched With the launch of Somediza Lifesciences, Alde enters the generic space backed by a clear goal to become one of India's most quality-focused generic pharma companies. The division aims to make trusted, affordable medicines accessible to all. * Critical Care Division Doubles Its Impact 2024 saw 100%+ growth in Alde's Critical Care Division, which now supplies to top hospitals like Metro Group and Venkateshwara Hospital in Delhi. The next phase of growth will focus on expanding into MAX Healthcare, Yashoda, and Kailash Hospitals, ensuring critical treatments are within reach when they're needed the most. Alde Medi: More Than a Manufacturer--A Platform for Ideas, Impact, and Innovation The conference wasn't just about business, it was a space for meaningful conversations and forward-looking ideas. Topics explored included: * The evolving regulatory landscape across countries * How AI and automation are reshaping pharmaceutical production * Best practices in clean, sustainable manufacturing * Opportunities for strategic partnerships across borders * Innovative product portfolio for next 2 years defined * Market penetration strategies were discussed It was a powerful reminder that healthcare is no longer local, it's global. And Alde Medi is ready to lead from the front. About Alde Medi Impex: A Legacy of Innovation and Trust Founded in 1997 , Alde Medi Impex has grown from a humble beginning into a globally respected name in pharmaceutical manufacturing. Backed by WHO, GLP, and ISO certifications, the company specialises in injectable dosage forms including Liquid Injections, Dry Powder Injections, and Lyophilized Injections delivering life-saving sterile solutions to both Indian and global markets. But Alde Medi is more than just a manufacturing powerhouse. It has earned its reputation as a reliable healthcare partner, with a focus on quality, compliance, and scalable operations. In addition to pharmaceuticals, the group is also building diversified platforms that cater to modern needs, across travel, shopping, and everyday conveniences. Our Ventures: * Alde Expression - A PIC/s & EU-GMP certified manufacturing facility * Alde Bazaar - A comprehensive e-commerce platform * Truvel - A smart travel booking platform Leadership Speaks: Building a Future That Cares "With each vial, every solution we make carries a promise--our promise to protect lives." -- Chairman, Alde Group The leadership at Alde Medi made it clear: while the company is scaling rapidly, it remains deeply rooted in its values, compassion, quality, and purpose. A people-first culture, where learning, innovation, and accountability go hand-in-hand, continues to drive the company's momentum forward. From One Room to the World: A Timeline of Growth * 1997- : Alde Medi was born with a five-member team and a big dream * 1997-2012: Expanded steadily across Uttar Pradesh and North India * 2012- 2018: Manas Rastogi ( in Biotechnology , MBA in Marketing from UK ) joined as marketing director . Exponential growth in domestic market - team size , new product launches , diversification to cardiology / neurology / metabolic products . These 6 years made alde medi one of the renowned name in north indian pharmaceutical industry. * 2019-2020: Manas promoted as CEO, Array of expansion and diversification began, transformation of alde medi impex limited to Alde group. Group companies : Globezza biotech ( nutraceutical division ) , somediza lifesciences ( generic division ) , Alde export ( international division ) , Alde medi ( marketing division ) , Alde real estate , Truvel services ( travel arm ) , Alde Bazaar ( E commerce ) * 2020-2025: Ambitious roadmap targeting 300% growth, global market expansion, and breakthrough innovations Looking Ahead The Business Conference 2025 was more than a corporate event, it was a celebration of shared purpose, progress, and possibility. With a clear focus on healthcare accessibility, sustainable innovation, and global partnerships, Alde Medi is building something bigger than just a business.


Business Standard
17-06-2025
- Business
- Business Standard
Hikal clears ANVISA GMP audit at Bengaluru API unit
Hikal said that it has successfully cleared the Good Manufacturing Practices (GMP) inspection conducted by the Brazilian Health Regulatory Agency (ANVISA) at its API manufacturing unit in Jigani, Bengaluru, Karnataka. The audit, which covered multiple active pharmaceutical ingredients (APIs), was conducted from 14 April to 18 April 2025. The successful completion of the inspection reinforces Hikals compliance with international quality standards and strengthens its position in regulated markets like Brazil. Hikal is engaged in the business of pharmaceuticals, crop protection, and specialty chemicals. The companys consolidated net profit rallied 48.08% to Rs 50.20 crore on 7.44% rise in revenue from operations to Rs 552.40 crore in Q4 FY25 over Q4 FY24. Shares of Hikal rose 0.29% to Rs 377.10 on the BSE.


Business Standard
17-06-2025
- Business
- Business Standard
Stock Alert: Zee Entertainment, Hikal, NTPC, Biocon, Hyundai Motor India
Secutries in F&O Ban: Aditya Birla Fashion & Retail (ABFRL), Birla Soft, Central Depository Services (CDSL), Chambal Fertilisers & Chemicals, HUDCO, Indian Renewable Energy Development Agency (IREDA), Manapurram Finance, RBL Bank and Titagrah Rail Systems shares are banned from F&O trading on 17 June 2025. Stocks to Watch: Zee Entertainments board approved the proposal to raise Rs 2,237 crore from promoter entities via issuing 16.95 crore warrants at issue price of Rs 132 per share. The warrants are proposed to be allotted to Altillis Technologies and Sunbright Mauritius Investments. Biocons board approved the issuance of qualified institutional placement (QIP) of Rs 4,500 crore at floor price of Rs 340.20 per equity share. Hikal has successfully passed the Brazilian Health Regulatory Agencys (ANVISA) GMP audit for its manufacturing unit located at Jigani in Bengaluru, Karnataka. The inspection, carried out by ANVISA, Brazil GMP (good manufacturing practices), was for multiple APIs which occurred from April 14th to April 18th, 2025. Hyundai Motor India has successfully commenced production of Passenger Vehicle Engines at its manufacturing facility Talegaon Plant located at Plot No. A-16, MIDC, Talegaon Industrial Area, Phase-II Expansion, Pune, Maharashtra, with effect from 16 June 2025. NTPCs board has scheduled a meeting on 21 June 2025, to consider the issuance of secured/ unsecured, redeemable, taxable/tax-free, cumulative/non-cumulative, non-convertible debentures (bonds/NCDs) aggregating upto Rs 18,000 crore, subject to approval of shareholders.


Business Standard
17-06-2025
- Business
- Business Standard
Indices drift lower in early trade; breadth positive
The key equity benchmarks traded with minor losses in early trade, driven by rising geopolitical tensions between Israel and Iran. Geopolitical developments are expected to continue influencing the market direction, as investors closely track crude oil prices, the G7 summit, Bank of Japans policy decision and the outcome of the upcoming U.S. Federal Reserve meeting later this week. The Nifty slipped below the 24,900 level. Pharma, auto and consumer durables shares declined while realty, media and PSU Bank shares advanced. At 09:25 IST, the barometer index, the S&P BSE Sensex declined 165.48 points or 0.20% to 81,630.67. The Nifty 50 index fell 66.55 points or 0.26% to 24,880.30. In the broader market, the S&P BSE Mid-Cap index rose 0.02% and the S&P BSE Small-Cap index fell 0.18%. The market breadth was positive. On the BSE, 1,436 shares rose and 1,348 shares fell. A total of 174 shares were unchanged. Foreign portfolio investors (FPIs) sold shares worth 2,539.42 crore, while domestic institutional investors (DIIs) were net buyers to the tune of Rs 5,780.96 crore in the Indian equity market on 16 June 2025, provisional data showed. Stocks in Spotlight: Zee Entertainment Enterprises advanced 1.52% after the companys board approved the proposal to raise Rs 2,237 crore from promoter entities via issuing 16.95 crore warrants at issue price of Rs 132 per share. The warrants are proposed to be allotted to Altillis Technologies and Sunbright Mauritius Investments. Biocon shed 0.92%. The companys board approved the issuance of qualified institutional placement (QIP) of Rs 4,500 crore at floor price of Rs 340.20 per equity share. Hikal rose 0.51%. The company has successfully passed the Brazilian Health Regulatory Agencys (ANVISA) GMP audit for its manufacturing unit located at Jigani in Bengaluru, Karnataka. The inspection, carried out by ANVISA, Brazil GMP (good manufacturing practices), was for multiple APIs which occurred from April 14th to April 18th, 2025. Numbers to Track: The yield on India's 10-year benchmark federal paper fell 0.22% to 6.257 from the previous close of 6.270. In the foreign exchange market, the rupee edged higher against the dollar. The partially convertible rupee was hovering at 85.8900 compared with its close of 86.0450 during the previous trading session. MCX Gold futures for 5 August 2025 settlement fell 0.29% to Rs 98,850. The US Dollar Index (DXY), which tracks the greenback's value against a basket of currencies, was up 0.01% to 98.17. The United States 10-year bond yield shed 0.49% to 4.430. Global Markets: US Dow Jones futures were down 133 points, signaling a weak start for Wall Street. Asian shares were a mixed bag on Tuesday as investors kept a close watch on the simmering Israel-Iran tensions. All eyes are now on the Bank of Japan, which is set to announce its policy decision later in the day. Expectations are that the BOJ will hold interest rates steady at 0.5%, opting for caution amid a murky global trade outlook. Back in the US, Wall Street closed in the green overnight. Hopes for a de-escalation in the Middle East boosted sentiment, with the Dow Jones climbing 0.75%, the S&P 500 gaining 0.94%, and the Nasdaq leading the rally with a 1.52% jump. On the corporate front, Roku shares popped after the company unveiled a new exclusive partnership with Amazon Ads. The deal is set to create the largest authenticated Connected TV (CTV) footprint in the US, a major win in the growing streaming ad market. Meanwhile, the US Federal Reserve begins its two-day meeting today. While interest rates are widely expected to remain unchanged at around 4.5%, the spotlight will be on any hints of a pivot to rate cuts, especially as inflation cools and growth shows signs of fatigue. Across the border, G7 leaders are gathering in Canada this week. The mood might be tense, with US President Donald Trumps tariffs on allied imports casting a shadow. Canadian PM Mark Carney has promised a push for peace and stability but hinted at potential retaliatory tariffs if Washington doesnt ease up on its steel and aluminum duties.