Latest news with #ActivePharmaceuticalIngredient
Business Standard
10 hours ago
- 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firms were unable to produce dozens of drugs— ranging from painkillers to psychiatric treatments— because of outdated price controls.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
Indian Express
02-05-2025
- Indian Express
Gujarat FDCA seizes 1 tonne of Pregabalin API ‘being traded without licence'
The Gujarat Food and Drugs Control Administration (FDCA) on Thursday said they have seized 1,000 kg of Active Pharmaceutical Ingredient (API) Pregabalin, used in the production of medicines used for treatment of various neurological disorders, that was being traded in bulk across several firms without any valid licence. The seized API is worth Rs 21.50 lakh, they added. Gujarat FDCA Commissioner Dr HG Koshia said that M/s Esteem Enterprises, Ahmedabad, which is trading in API, was raided and evidence of sale of 4,300 kg of Pregabalin worth approximately Rs 85 lakh, was found. Investigation into the dealing of this company then took the FDCA investigators to those allegedly manufacturing these APIs. Pravin Patel, the owner of Axis Pharmachem, and Bhavesh, a partner in Iconic Pharmachem, and others,were found to be manufacturing Pregabalin in their chemical factory in Panoli village of Ankleshwar taluka in Bharuch district, despite not having any kind of licence to manufacture drugs, according to a press note by FDCA. Further, the FDCA statement said that testing of this product was conducted by Biochrome Analytical Lab, Ankleshwar, Bharuch, despite not having any kind of licence, and that it was sending test reports to them through WhatsApp without keeping any legal documents. Upon further investigation in this case, the authorities came to know that M/s Esteem Enterprise, Ahmedabad, had opened a branch in Bharuch and was selling API Pregabalin and other API chemicals without any kind of licence, and was selling API in large quantities, the statement read. Several samples of the API have been sent to the drug-testing lab in Vadodara. Further investigation is underway.
Yahoo
22-04-2025
- Business
- Yahoo
CARBOGEN AMCIS Shanghai Site Awarded Drug Manufacturing License from Chinese NMPA
CARBOGEN AMCIS Shanghai BUBENDORF, Switzerland, April 22, 2025 (GLOBE NEWSWIRE) -- CARBOGEN AMCIS, a Switzerland-based pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company is pleased to announce that its Shanghai facility has successfully obtained its first Drug Manufacturing License (DML) from China's National Medical Products Administration (NMPA). The NMPA approval followed a rigorous review focused on GMP compliance and operational readiness. The Shanghai site successfully met all regulatory expectations, reflecting the maturing of its operations and the strength of its quality systems. This milestone marks a pivotal step in CARBOGEN AMCIS' expansion in China and reinforces its commitment to customers in the region. Located in the Shanghai Chemical Industry Park (SCIP), the 40,000m² site is a fully self-supporting facility equipped for early-phase research and development, pilot scale production and commercial GMP manufacture. Its services range from raw materials to APIs, including high potency material handling and micronization. With equipment in four segregated units and reactor capacities from 50 to 6,300 litres, the facility is built for flexibility, efficiency and scalability. The site employs over 140 people and brings together an international team of specialists whose expertise, combined with advanced infrastructure, enables the delivery of tailored, scalable solutions to customers worldwide. 'This achievement underscores our team's commitment, disciplined execution, and the robustness of our Quality Management System, which has been rigorously aligned with both corporate and Chinese regulatory requirements,' said Simone Maggi, Quality Head - CARBOGEN AMCIS Shanghai site. 'In addition to our core manufacturing capabilities, we're proud that the Shanghai site is equipped to handle highly potent compounds up to category 3 and provide full GMP product release and analytical support,' said Harry Wong, Country Manager, CARBOGEN AMCIS Shanghai. 'This license is a testament to the strength of our team and demonstrates our ability to execute seamless technology transfers and align with the highest quality standards across CARBOGEN AMCIS' global network.' Stephan Fritschi, CEO at CARBOGEN AMCIS, stated: 'Securing the Drug Manufacturing License not only demonstrates the operational readiness of our Shanghai site but also reflects the strength of our global quality culture. This achievement strengthens our long-term goal of becoming a trusted partner in the Chinese pharmaceutical market.' He added, 'I would like to take this opportunity to express my gratitude to every member of our site team for their dedication and to the Executive Team for their continuous support and trust throughout this journey.' For further information contact: Denise Neufeld +41 79 213 06 60 CARBOGEN AMCIS ( is a leading service provider offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries across all stages of clinical development and product life cycle. Our integrated services and innovative chemistry solutions support timely and safe drug development, allowing customers to better optimize available resources. CARBOGEN AMCIS is a wholly owned subsidiary of Dishman Carbogen Amcis Limited, Ahmedabad, India. A photo accompanying this announcement is available at
