Latest news with #ActivePharmaceuticalIngredient
Business Standard
5 days ago
- Business
- Business Standard
Alembic Pharma receives USFDA EIR for Karakhadi API facility
Alembic Pharmaceuticals said that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API)-III facility in Karakhadi, Gujarat. The inspection was conducted at the API-III facility from 17th March 2025 to 21st March 2025. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24. Shares of Alembic Pharmaceuticals shed 0.78% to Rs 962.70 on the BSE.
Business Upturn
12-06-2025
- Business
- Business Upturn
Top stocks to watch today, June 12: ONGC, Oil India, Zydus, Waaree Energies, RailTel, Paytm and more
Indian equity markets extended gains on Wednesday, June 11, tracking positive global cues and supported by continued foreign fund inflows. The benchmark BSE Sensex rose by 123.42 points or 0.15% to close at 82,515.14. The broader NSE Nifty advanced by 37.15 points or 0.15%, ending at 25,141.40. This marked the sixth consecutive session of gains for the Nifty. On Thursday, June 12, several stocks are expected to remain in focus following company-specific developments and announcements. Stocks to Watch on June 12: 1. ONGC, Oil India (OIL): Crude oil prices surged over 4% amid rising tensions in West Asia. Brent crude approached the $70 per barrel mark, potentially impacting oil exploration and marketing companies (OMCs) and downstream sectors like paints and aviation. 2. Zydus Lifesciences: The US FDA has cleared the company's Active Pharmaceutical Ingredient (API) manufacturing facility in Dabhasa, Gujarat. An Establishment Inspection Report (EIR) has been issued, which indicates successful completion of the inspection. 3. Sterlite Technologies (STL)/Dilip Buildcon: The joint venture of STL and Dilip Buildcon secured a contract from BSNL under the BharatNet project. The order, valued at ₹2,631 crore, covers network deployment in Jammu & Kashmir and Ladakh. 4. Waaree Energies: The company signed a Power Purchase Agreement (PPA) for 150 MW out of its 170 MW solar project capacity. The agreement is with Rewa Ultra Mega Solar Ltd and MP Power Management Company Ltd. 5. RailTel Corporation: RailTel received a work order worth ₹12 crore from South Eastern Coalfields Ltd. The scope includes IT and communication-related infrastructure services. 6. City Union Bank: The bank's board approved raising up to ₹500 crore through Qualified Institutional Placement (QIP), subject to regulatory and shareholder approvals. 7. SEPC Ltd: SEPC has been awarded a Letter of Award (LoA) from Parmeshi Urja Ltd for executing a 133 MW AC solar project across 26 locations in Maharashtra. The total project value is ₹650 crore. 8. HG Infra Engineering: HG Infra was declared the lowest bidder for an interstate transmission system project under the Eastern Region Generation Scheme-I in Odisha. The contract spans 35 years with expected annual transmission charges of ₹43 crore. 9. Northern Arc Capital: The Reserve Bank of India (RBI) has granted approval to Northern Arc to commence and operate as a factoring business under relevant regulatory provisions. 10. Lemon Tree Hotels: The company announced the signing of a new property in Madhya Pradesh. The hotel will feature 72 rooms and expand the company's footprint in the central Indian market. 11. OMCs and Paint Companies: With crude oil prices climbing over geopolitical tensions, stock movements in oil marketing companies and industries dependent on crude derivatives, such as paints, may witness volatility. 12. Paytm: The Ministry of Finance clarified that speculation around Merchant Discount Rate (MDR) being applied to UPI transactions is unfounded and baseless, impacting sentiment around digital payment stocks. 13. MCX: The National Stock Exchange (NSE) received SEBI's approval to launch electricity futures, introducing competition in the energy derivatives market. 14. C.E. Info Systems (MapmyIndia): PhonePe is reportedly planning to offload up to a 5% stake in the company via block deals. The floor price is expected to be at a 10% discount to the current market price. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information.
Business Standard
10-06-2025
- Business
- Business Standard
Zydus Life receives USFDA EIR for Dabhasa API facility
Zydus Lifesciences announced that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility located at Dabhasa, near Vadodara. The facility underwent an inspection from April 21 to April 25, 2025. The inspection has been classified as Voluntary Action Indicated (VAI), with the FDA confirming the inspection as "closed". The companys consolidated net profit shed 0.96% to Rs 1,170.9 crore on 17.21% rise in revenue from operations to Rs 6290.2 crore in Q4 FY25 over Q4 FY24. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Shares of Zydus Lifesciences rose 0.71% to Rs 980 on the BSE.
Business Standard
06-06-2025
- Business
- Business Standard
Carbogen Amic AG to co-invest in its manufacturing sites in Switzerland
Dishman Carbogen Amcis' wholly owned subsidiary, CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) and drug products manufacturing company, announced a strategic co-investment of more than CHF 25 million with a long-standing Japanese customer to expand manufacturing capabilities at its sites in Aarau and Neuland, Switzerland. The investment will support the production of a drug linker for a commercial antibody-drug conjugate (ADC), enabling CARBOGEN AMCIS to meet rising global demand. As part of the agreement, both facilities will see significant equipment and infrastructure enhancements, including: Aarau site: installation of 850-litre reactors and 0.4 m agitated filter dryers with supporting equipment. Completion is expected by Q1 2027. Neuland site: installation of 850-litre reactors and 0.4 m agitated filter dryers with auxiliary systems. Completion is anticipated by Q3 2027. This project builds on a previous joint funding agreement between CARBOGEN AMCIS and the same customer in April 2021 to develop a site extension at the Bubendorf site in Switzerland, reinforcing the strength of the relationship and their shared commitment to long-term growth.
Business Recorder
20-05-2025
- Business
- Business Recorder
PPMA says price deregulation helps restore medicine availability
KARACHI: The government's decision to deregulate prices of non-essential medicines has helped restore the availability of critical drugs across Pakistan, ending months of shortages that had severely impacted public health, experts and industry officials said on Monday. 'The policy shift has addressed critical supply gaps. Medicines that had vanished due to unviable prices are now back, offering relief to patients who were left at the mercy of black markets or counterfeits,' said Tauqeer-ul-Haq, Chairman of the Pakistan Pharmaceutical Manufacturers Association (PPMA), while speaking to reporters here. For years, pharmaceutical firms were unable to produce dozens of drugs— ranging from painkillers to psychiatric treatments— because of outdated price controls. 'When a tablet priced at Rs3 can't be produced at cost, it disappears. Deregulation allowed us to price it at Rs6 and bring it back to patients,' Haq explained. 'The most expensive medicine is the one that isn't available.' Under the new framework, pharmaceutical companies can adjust prices of non-essential medicines in line with inflation and production costs. However, essential and life-saving drugs— more than 460 in number— remain under strict price regulation. This hybrid model mirrors international best practices, allowing market forces to stabilize supply while keeping vital medicines affordable. According to the PPMA chairman, the impact has been swift. Local manufacturers have resumed production, and multinational firms are reconsidering their plans to exit the market. 'The intent is not to increase prices indiscriminately, but to ensure sustainable production and eliminate dangerous alternatives,' he said. The resolution of long-pending hardship cases, some delayed for over three years, has also contributed to the supply revival. With bureaucratic hurdles removed, medicines like insulin, antibiotics, and cardiac treatments are once again accessible to patients. Industry data supports these developments. IQVIA reports that Pakistan's pharmaceutical market crossed the Rs1.049trillion mark by March 2025, reflecting 20.62 percent growth in rupee value. While the surge is largely attributed to price adjustments and the reintroduction of long-unavailable drugs, experts estimate, actual organic growth— excluding one- time recoveries—stands at 15 to 16 percent, indicating market stabilisation. Beyond restoring availability, the policy shift is expected to attract investment in local Active Pharmaceutical Ingredient (API) manufacturing, reducing Pakistan's 90 percent reliance on imports. Public-private partnerships, including ventures under CPEC, are being explored to build domestic resilience and reduce exposure to global supply shocks. The industry also foresees job creation, particularly for young pharmacists, technicians, and quality assurance professionals. Improved pricing structures are expected to support infrastructure upgrades and pave the way for international certifications—potentially boosting Pakistan's $700 million pharma exports. While concerns over rising prices remain, experts and industry leaders argue that the broader gains—improved availability, reduced counterfeit risk and production sustainability—far outweigh the short-term impact. 'This isn't just about business,' Haq emphasized. 'It's a public health imperative.' Clinical pharmacists and pharmacologists also noted that deregulation has helped restore the supply of previously unavailable medicines, with patients finally gaining access to treatments that had vanished due to price constraints. They added that shortages have eased noticeably in recent months, and the availability of genuine medicines has reduced reliance on unsafe alternatives. Copyright Business Recorder, 2025
