Dr Reddy's NY API plant gets USFDA Form 483 with 2 observations
Dr. Reddy's- building
HYDERABAD: Pharma major Dr Reddy's Laboratories on Saturday said its
active pharmaceutical ingredients
manufacturing facility
at
Middleburgh
in New York has been issued a Form 483 with two observations by the US drug regulator, US Food and Drug Administration (US FDA).
'We have been issued a Form 483 with two observations, which we will address within the stipulated timeline,' Dr Reddy's said in a
regulatory filing
.
The Hyderabad-based company said the good manufacturing practices (GMP) inspection was conducted by US FDA between May 12, 2025, and May 16, 2025, the company said.
A Form 483 is issued by USFDA inspectors to the management of the company at the end of an onsite inspection if inspectors find any violations of the Food, Drug and Cosmetic (FD&C) Act or other regulations, as per USFDA.
Stay informed with the latest
business
news, updates on
bank holidays
and
public holidays
.
AI Masterclass for Students. Upskill Young Ones Today!– Join Now
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Mint
an hour ago
- Mint
Small-cap stock below ₹200 hits 52-week high upper circuit after THIS overseas business update
Small-cap stock below ₹ 200: Aayush Wellness share price hit 52-week high by surging 2 per cent upper circuit in Tuesday's trading session to ₹ 154.05 apiece after the board approved the formation of wholly owned subsidiary in Singapore with an initial capital investment of SGD 10,000. The small-cap stock has gained over 51 per cent in last one month. In last one year, Aayush Wellness stock has given multibagger returns to its investors by ascending over 782 per cent. In a release dated June 9, the company said that this strategic expansion marks a significant step in the company's global growth strategy and will serve as a launchpad for its nutraceutical and healthcare products across the rapidly expanding Southeast Asian markets. 'Our new Singapore-based subsidiary will enable us to tap into one of the world's most dynamic wellness markets, offering greater agility in operations, regulatory efficiency, and direct access to high-growth ASEAN economies. This is a critical step toward building a global wellness brand," Naveena Kumar, Managing Director of Aayush Wellness said. The company further said that the expansion would focus on the following areas - Localizing product offerings to align with regulatory and cultural preferences, forging strategic partnerships and e-commerce distribution channels across ASEAN, driving export growth from India while expanding the company's international brand presence, establishing a regional R&D and innovation hub to adapt to market-specific wellness trends. ' This development is in line with Aayush Wellness Limited's broader mission to deliver science-backed, sustainable, and natural healthcare solutions globally. The company aims to use its new presence in Singapore to not only access markets in Malaysia, Indonesia, Thailand, and Vietnam, but also to establish a foundation for future global partnerships and innovation,' the company said.
Indian Express
an hour ago
- Indian Express
Getty Images and Stability AI face off in British copyright trial that will test AI industry
Getty Images is facing off against artificial intelligence company Stability AI in a London courtroom for the first major copyright trial of the generative AI industry. Opening arguments before a judge at the British High Court began on Monday. The trial could last for three weeks followed by a written decision from the judge expected at a later date. Stability, based in London, owns a widely used AI image-making tool that sparked enthusiasm for the instant creation of AI artwork and photorealistic images upon its release in August 2022. OpenAI introduced its surprise hit chatbot ChatGPT three months later. Seattle-based Getty has argued that the development of the AI image maker, called Stable Diffusion, involved 'brazen infringement' of Getty's photography collection 'on a staggering scale.' Tech companies have long argued that 'fair use' or 'fair dealing' legal doctrines in the United States and United Kingdom allow them to train their AI systems on large troves of writings or images. Getty was among the first to challenge those practices when it filed copyright infringement lawsuits in the United States and the United Kingdom in early 2023. 'What Stability did was inappropriate,' Getty CEO Craig Peters told The Associated Press in 2023. He said creators of intellectual property should be asked for permission before their works are fed into AI systems rather than having to participate in an 'opt-out regime.' Getty's legal team told the court Monday that the case isn't a battle between the creative and technology industries and that the two can still work together in 'synergistic harmony' because licensing creative works is critical to AI's success. 'The problem is when AI companies such as Stability AI want to use those works without payment,' Getty's trial lawyer, Lindsay Lane, said. She said the case was about 'straightforward enforcement of intellectual property rights,' including copyright, trademark and database rights. Getty Images 'recognizes that the AI industry is a force for good but that doesn't justify those developing AI models to ride roughshod over intellectual property rights,' Lane said. Stability AI had a 'voracious appetite' for images to train its AI model, but was 'completely indifferent to the nature of those works,' Lane said. Stability didn't care if images were protected by copyright, had watermarks, were not safe for work or were pornographic — it just wanted to get its model to the market as soon as possible, Lane said. 'This trial is the day of reckoning for that approach,' she said. Stability lawyers are expected to make their opening arguments Tuesday. They say in a prepared written argument that Getty's claims 'represent an overt threat to Stability's whole business, and the wider generative AI industry.' Stability has argued that the case doesn't belong in the United Kingdom because the training of the AI model technically happened elsewhere, on computers run by U.S. tech giant Amazon. The company also argues that 'only a tiny proportion' of the random outputs of its AI image-generator 'look at all similar' to Getty's works. Once the trial concludes later this month, the judge's decision is unlikely to give the AI industry what it most wants, which is expanded copyright exemptions for AI training, said Ben Milloy, a senior associate at UK law firm Fladgate, which is not involved in the case. But it could 'strengthen the hand of either party – rights holders or AI developers – in the context of the commercial negotiations for content licensing deals that are currently playing out worldwide,' Milloy said. Similar cases in the U.S. have not yet gone to trial. In the years after introducing its open-source technology, Stability confronted challenges in capitalizing on the popularity of the tool, battling lawsuits, misuse and other business problems. Stable Diffusion's roots trace back to Germany, where computer scientists at Ludwig Maximilian University of Munich worked with the New York-based tech company Runway to develop the original algorithms. The university researchers credited Stability AI for providing the servers that trained the models, which require large amounts of computing later blamed Runway for releasing an early version of Stable Diffusion that was used to produce abusive sexual images, but also said it would have exclusive control of more recent versions of the AI model. Stability last year announced what it described as a 'significant' infusion of money from new investors including Facebook's former president Sean Parker, who is now chair of Stability's board. Parker has experience in intellectual property disputes as the co-founder of online music company Napster, which temporarily shuttered in the early 2000s after the record industry and popular rock band Metallica sued over copyright violations. Hollywood director James Cameron, whose films include 'Titanic' and 'Avatar' is also a Stability board member. The new investments came after Stability's founding CEO Emad Mostaque quit and several top researchers left to form a new German startup, Black Forest Labs, which makes a competing AI image generator.
Time of India
an hour ago
- Time of India
How Marcel plans to excel in the age of AI
When Marcel unveiled "WoMen's Football", a provocative campaign for telecom giant Orange that swapped male player highlights with female athlete performances mid-match, it wasn't merely an advertising stunt—it was a cultural wake-up call. Ranked number one in WARC's Creative 100 for 2025, this daring initiative wasn't about chasing trends but rather shaping them. Behind such bold ideas stands Youri Guerassimov , CEO of Marcel, whose approach combines creative bravery with meticulous strategic insight. Under Guerassimov's stewardship, Marcel has emerged as an influential voice among global creative agencies, balancing artistry and commerce with remarkable finesse. From tackling e-waste with Back Market's irreverent " Hack Market " campaign to reshaping gender perceptions through provocative storytelling, the Paris-based agency has accumulated an enviable collection of accolades from Cannes Lions, D&AD, and the Effies. In this edition of Economic Times Brand Equity's Digital Cover , Guerassimov discusses how authenticity forms the core of impactful advertising, the unexpected realities of transitioning from creative director to CEO, and why he believes artificial intelligence is not a threat, but rather a transformative tool reshaping the future of creativity. Edited Excerpts: How do you ensure that authenticity remains at the core of what you do? At the heart of what we do at our agency is a commitment to staying true to the brand, and of course, to the people and our target audience. It's a strategic approach from the very beginning—even before we start the creative process. We have a very strong strategic department that works deeply on the brands and briefs. We gain a strong understanding of the brand, the target, and what we are supposed to do. At the same time, we stay close to pop culture and try our best to remain connected to what people are talking about in India and what is happening around us. I would like to say 'every time', but most of the time, we are true to people and to what is happening, which makes our advertisements more efficient and powerful. Where does this inspiration to be true and real come from? It's part of a technical approach, which is why we talk about strategies. People are digging to see, to find, to understand the technical side. At the same time, the creative approach begins with being curious, curious in every possible way. You always have to be aware of what's happening in the country and in the world, so you become like a library of what people's lives are like. You take time to observe what people think, what they do, and that always helps you stay accurate in your work. You try your best to achieve that. You talked about bold ideas, how to be brave, then there's a client objective as well, their business goals. How do you balance the two? On one side you wish to be creative and on the other side you also want to deliver to the goals that the client has? We are not working in show-business; we are working in advertising. In a way, it sits between arts and commerce. Everyone would say it's more commerce than arts, but we use art to serve commerce. So, we should be aligned with the client. If the client has a problem, like making people aware of their latest project, we need to solve that problem with a creative approach. Both are linked. Boldness alone doesn't make sense; we need to use that boldness, we need to use creativity to help our client, our brand, achieve something. It's part of our job, part of our experience, and part of our skills to get it right. Sometimes you try to be bold and it doesn't succeed, or it isn't accurate, and that's also part of the agency's experience. And of course, it's the role of the creative director, who is supposed to be the one responsible for that, the ideas must be accurate for the client and the brief. Boldness or being brave isn't being foolish. When I was CCO, if we had to go on a trip to Paris, we'd take business class tickets. It would cost, say, 1,000 euros. Now, as CEO, I do the opposite. I say let's take economy class, because it's only a one-hour trip and it will cost 300 instead of 1,000 eurosYouri Guerassimov From a creative director to a CEO, you are balancing between a storyboard and an Excel sheet. Has it changed your thought process? Did you start differently when you became a CEO? The answer is yes. I think most people would love to hear 'no', but yes, it changed a lot of things, and maybe it's for the best. It's always a question of balance, of how to frame the right balance. Hopefully, the idea I'm working to achieve at the top of the agency is also about finding the right compromise. That's why you need someone who is very creative, very passionate, and who understands how an agency works, how a business works, so you can find exactly the right balance. You're always trying, always in the process. It's not easy or obvious. Every day, I try to find the right balance between creativity, investment, and talent in the product, and at the same time make it profitable, so the agency can continue to exist and continue to earn money. Because we all need money to make it work, to bring in more people with diverse skills. Many people don't accept the fact that they changed after being CEO but you did that… can you give an example - what changed? Let me give you an example. When I was CCO, if we had to go on a trip to Paris, we'd take business class tickets. It would cost, say, 1,000 euros. Now, as CEO, I do the opposite. I say let's take economy class, because it's only a one-hour trip and it will cost 300 instead of 1,000 and put more entries from the 700 we saved. That's the difference. It's not the same mindset anymore. You have to find the right balance and make the right choice, and that's exactly what's happening. I understand that the money is the same, whether you spend it on a plane ticket, an event entry, or a party, it's still the same money. So, it's always about making choices. It's like an art director who doesn't use Photoshop - today, that person wouldn't really be considered an art director in advertising. It will probably be the same for AI in a few yearsYouri Guerassimov It's no longer just about awareness, it's also about driving loyalty and advocacy after conversion. How do you see the client's expectations changing, and how are you adapting to these emerging expectations? I think we were ready for that for years. In a way, I was expecting that clients would change their mindset, because I believe advertising and communication today are a matter of balance. A brand should have a long-term vision, while also doing something fresh, sometimes very business-oriented, sometimes a big call to action. You should use the full range of what we can offer as advertisers, for the brand, because that's what works and what people expect too. What is Creativity in the age of AI vs what it was before? Through your vantage point… It's a trendy question, and I have a partial answer. I think we are only at the beginning of AI - we're just discovering it, and we're all trying to see how it can change the way we work and improve the quality of our output. We're very invested in AI, and I believe the agency is really on the edge, trying to move forward with it. It's already changing how we work. Presentations are now really beautiful, there's a big improvement in timing, and we're able to work more quickly, which is great. The craft has become much better. We also use ChatGPT and similar tools to make writing easier or to get fresh perspectives. Some wise people on the internet say that AI won't replace creatives, it's the creatives who use AI that will replace agencies that don't. We're ready for that. We just need to embrace it and make the most of it. Everything is moving fast, but we have to stay aware and always know what's happening. Maybe the biggest revolution is just around the corner. So, if a 20-year-old comes to you asking for an internship of 6 months to prove he is good, will you ask him whether he knows how to do AI prompts? What's hiring like in the age of AI? No, the most important thing is the idea. So when I hire someone, I need them to bring great ideas, the feeling, the passion, the understanding-to make me feel confident that this person will do great work. Of course, I'll then ask what kind of tools they use, and AI is everywhere now. ChatGPT is a great tool to refresh the mind and get quicker answers, so yes, I'll definitely ask, but it's not mandatory for me. I'm sure in a few years it will become normal. It's like an art director who doesn't use Photoshop - today, that person wouldn't really be considered an art director in advertising. It will probably be the same for AI in a few years. Where do you see the first impact of AI coming in, is it in design or in writing? Like using ChatGPT everyone seems to be a writer now? Maybe because I am a former art director, I would say the biggest difference is in the craft. The transformation is really amazing. ChatGPT is clearly a useful writing tool that helps our copywriters, but the change there is less obvious. In the art direction path, it's just crazy. I've seen some good creatives who were not really strong art directors suddenly become the ones delivering beautifully crafted images. That feels like magic, because developing that level of skill used to take seven to ten years. Now the machine can do it. If you have the right vision in your head, the machine will help you bring it to life in the proper way. You no longer need to be extremely technical, but you still need an art direction background, or at least good taste. You must know in your mind what the result should look like, because that is still part of the art director's job. What used to take three or four days now takes three hours. For me, that is the crazy part. It's just magic. Now what if a client starts thinking why should I give you 48 hours of time, it's the era of AI… give it to me in 15 mins, 1 hour or 2 hours? I get your point. Depending on the mockup, it can be very different. You can create something very beautiful very quickly, but getting exactly what you want can take a lot of time, really a lot of time. You need the right expression, the right positioning. We have also noticed that sometimes AI just does not understand certain parts of the mockup. Sometimes we make drawings or even 3D models to help AI understand precisely what we want, creating situations where the AI has no choice but to use exactly what we have given it. What is it that you want to keep as Marcel's legacy, when people look at it in a decade, what do you think Marcel's legacy should be? It's a difficult question. I hope people will think that we created great ideas and made people love our brands and clients. I believe that is the legacy. We do everything across all kinds of media, and we would love for people to recognise that it is not just about how we do it, but that we do everything possible to deliver great ideas for our clients.
