Latest news with #USFDA
Business Standard
2 days ago
- Business
- Business Standard
Zydus' Matoda facility completes Remote Regulatory Assessment of USFDA
Zydus Lifesciences announced that the USFDA conducted a Remote Regulatory Assessment (RRA) at Zydus' formulations manufacturing facility at Matoda in Gujarat for the Prior Approval Supplement (PAS) of Atorvastatin Calcium Tablets USP, 10 mg, 20 mg, 40 mg and 80 mg. At the closure, there were no observations noted, and the site was recommended for approval.
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Business Standard
2 days ago
- Business
- Business Standard
Why did Shilpa Medicare share jump 5% in trade today? top details here
Shilpa Medicare share price: Pharmaceutical company Shilpa Medicare share price was in demand on Wednesday, July 16, 2025, with the scrip rising up to 4.99 per cent to hit an intraday high of ₹939.10 per share. Around 1:30 PM, Shilpa Medicare share price was trading 4.93 per cent higher at ₹938.50. By comparison, BSE Sensex was trading 0.08 per cent lower at 82,640.01 levels. CATCH STOCK MARKET LIVE UPDATES TODAY Why did Shilpa Medicare share price rise in trade today? Shilpa Medicare share price gained in trade after the company announced a positive regulatory update from the US health regulator, United States Food and Drug Administration (USFDA). The pharma firm said its Unit VI at Dabaspet, Bengaluru received an Establishment Inspection Report (EIR) with a 'Voluntary Action Indicated' (VAI) classification from the USFDA. The EIR followed a Good Manufacturing Practices (GMP) inspection conducted between October 24-30, 2024. In an exchange filing, Shilpa Medicare said, 'This is to inform you that Shilpa Medicare Limited, Unit VI, Dabaspet, Bengaluru, Karnataka, India has received EIR with VAI (Voluntary Action Indicated) classification, from USFDA, for the GMP inspection which was conducted from October 24 – 30, 2024.' The unit is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms including Oral Dissolving Films and Transdermal Systems. Meanwhile, the unit already holds approvals from key global regulators, including EMA (Europe), MHRA (UK), SFDA (Saudi Arabia), and TGA (Australia). It currently supplies oral film products to the US and other markets, while filings for transdermal products have been made in Europe. Shilpa Medicare Q4 results Shilpa Medicare reported a mixed set of numbers in Q4FY25. While revenue from operations grew 13.3 per cent year-on-year (Y-o-Y) to ₹330.80 crore and earnings before interest, tax, depreciation and amortisation (Ebitda) rose 15 per cent to ₹84 crore, net profit (PAT) declined 40.8 per cent to ₹14.51 crore. About Shilpa Medicare Shilpa Medicare Limited is a global pharmaceutical company with a strong presence in regulated markets such as the USA, Europe, and Japan. The company specialises in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and finished dosage formulations, with a particular focus on oncology. Its product range includes tablets, capsules, injectables, and transdermal patches, all manufactured to meet international quality standards. Additionally, Shilpa Medicare provides end-to-end Contract Development and Manufacturing Organisation (CDMO) services, catering to a wide spectrum of pharmaceutical needs. Beyond its core offerings, the company is actively investing in research and development, focusing on novel drug delivery systems and expanding into emerging therapy areas, including biotech products. The market capitalisation of Shilpa Medicare is ₹9,177.68 crore, according to BSE. The company falls under the BSE SmallCap category.
Business Standard
2 days ago
- Business
- Business Standard
Shilpa Medicare gains as unit VI gets USFDA EIR with VAI classification
Shilpa Medicare added 2.94% to Rs 920.70 after the company announced that its Unit VI facility in Dabaspet, Bengaluru, Karnataka, has received EIR with VAI (Voluntary Action Indicated) classification from USFDA, for the GMP inspection. The good manufacturing practice (GMP) inspection was conducted from 24 October 2024 to 30 October 2024. This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms - oral dissolving films and transdermal systems. The Unit is already approved by EMA, Europe; MHRA, UK; SFDA, Saudi and TGA, Australia. This Unit is currently supplying Oral Film products to US and other markets. Transdermal products have been filed in the European market. Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India. The company's consolidated net profit fell 40.77% to Rs 14.51 crore, while revenue from operations rose 13.40% to Rs 330.80 crore in Q4 FY25 over Q4 FY24.
Business Upturn
2 days ago
- Business
- Business Upturn
SMS Lifesciences gets EIR from USFDA for API manufacturing facility at Kazipally
By Aman Shukla Published on July 16, 2025, 12:09 IST SMS Lifesciences has received the Establishment Inspection Report (EIR) from the USFDA for its API manufacturing facility at Kazipally, Telangana. The inspection concluded with a 'Voluntary Action Indicated' (VAI) classification. This EIR, received on July 15, 2025, confirms the company's adherence to global quality norms and clears the way for continued exports to the US and other regulated markets. It follows an earlier inspection update shared by the company in May this year. In the exchange filings, SMS Lifesciences shared, 'We are pleased to inform that the Company has received Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration for our API manufacturing facility (Unit 1) located at Kazipally, Telangana, on July 15, 2025 at 09.37 pm.' The development strengthens SMS Lifesciences' position as a reliable global API supplier. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
India Today
2 days ago
- India Today
Apple AirPods Pro 2 now work as hearing aid in more countries, is India on the list?
Apple's AirPods Pro 2 can do more than just help you enjoy music or take calls — they also double up as a hearing aid for those with perceived mild to moderate hearing loss. It's a feature that has been quietly rolled out to more than 100 countries since getting a green light from the US FDA, and it's slowly starting to catch the attention of users across the world. Along with that, there's also something called Media Assist, which improves clarity while watching videos, listening to music, or even during phone calls. Together, these features bring the AirPods Pro 2 closer to clinical-grade hearing solutions, but with the comfort and convenience of a pair of earbuds you can use new Hearing Aid mode uses the results of a hearing test you take on your iPhone or iPad, or an audiogram provided by a hearing care professional. Based on this, your AirPods will adjust the sound output to match your specific hearing needs. It's available only on the AirPods Pro 2 with the latest firmware and works with devices running iOS 18 or later. Apple says the feature is designed for people aged 18 and far, Apple has rolled out this feature in over 100 major markets, like the US, UK, Australia, Japan, Germany and several others. However, if you're in India, the option to turn on the hearing aid function is still missing. That's because it hasn't received the necessary medical device clearances from regulators here. This hasn't stopped curious users from trying to find workarounds, though. According to an Economic Times report from late last year, a few Bengaluru-based engineers found a creative solution by tricking the AirPods into thinking they were in a supported region, and enabled the feature using a Faraday cage and spoofed Wi-Fi location data. Their efforts helped their family members, particularly the elderly, get access to better hearing tools in a much simpler form factor than traditional hearing aids. For users in countries where the feature is supported, setting it up is straightforward. First, make sure your AirPods Pro 2 have the latest firmware. Then, with the AirPods connected to your iPhone or iPad, head to Settings > your AirPods > Hearing Assistance. From here, you can either take a hearing test or upload previous results from a hearing professional. The feature then fine-tunes your AirPods to suit your hearing profile. It might take a bit of time to adjust, but most users find it helpful after a few days of of now, there's no official word on when the feature might become available in India. But with global accessibility improving and interest growing, it's likely just a matter of time. For now, users in supported countries can enjoy a more personalised and accessible audio experience using a device they already own.- Ends
