Glenmark Pharma’s manufacturing facility has successfully undergone a U.S. FDA inspection without receiving any observations.
Glenmark Pharmaceuticals, a prominent drugmaker, has successfully completed a pre-approval inspection by the U.S. Food and Drug Administration (FDA) at its formulations manufacturing facility in Chhatrapati Sambhajinagar, Maharashtra. The inspection, which took place from November 24-28, concluded with zero Form 483 observations, indicating that the facility met all the necessary regulatory requirements.
This development is a significant milestone for the company, particularly in light of the recent inspection of its formulations manufacturing facility in North Carolina, USA. The U.S. FDA had inspected the Monroe site from June 9-17 and issued a Form-483 with five observations, resulting in a warning letter being issued in June 2023. However, following corrective actions, the facility has now received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status, allowing commercial manufacturing to restart.
The successful inspection of the Chhatrapati Sambhajinagar facility and the resolution of the issues at the North Carolina site demonstrate Glenmark Pharmaceuticals’ commitment to meeting the highest standards of quality and regulatory compliance. The company’s ability to address the FDA’s concerns and achieve a favorable outcome is a testament to its capabilities and dedication to delivering high-quality products to patients.
The completion of the inspection with zero Form 483 observations is a notable achievement, as it indicates that the facility has met all the necessary regulatory requirements without any major deficiencies. This outcome is likely to enhance the company’s reputation and credibility in the pharmaceutical industry, both in India and globally. With the restart of commercial manufacturing at the Monroe site, Glenmark Pharmaceuticals is poised to continue delivering its products to patients in the U.S. market, while also maintaining its commitment to quality and regulatory compliance. Overall, this development is a positive step forward for the company, and it is likely to have a favorable impact on its business operations and reputation.
Andhra University inks two Memoranda of Understanding with Survey of India and Aurobindo Pharma
Andhra University in Visakhapatnam (Vizag) has taken a significant step towards enhancing student employment and research opportunities by signing two memoranda of understanding (MoUs) with the Survey of India and Aurobindo Pharma Foundation. The agreements aim to provide students with internship opportunities, joint research initiatives, and academic support.
The five-year MoU with the Survey of India was signed by AU registrar Professor K Rambabu and additional surveyor general G Varuna Kumar, in the presence of vice-chancellor Professor G P Rajashekar. This partnership will enable students to gain access to internships at the National Institute for Geo-information and Technology, as well as participate in joint research projects, workshops, and conferences. The institutions will also facilitate the sharing of valuable information and provide academic support to students. Additionally, eligible staff from the Survey of India will be able to pursue ME, MTech, and PhD programs at Andhra University.
In a separate agreement, Andhra University has signed a ten-year MoU with the Aurobindo Pharma Foundation. As part of this partnership, a Skill Development Centre will be established in the Department of Chemistry at Andhra University. The centre will be equipped with state-of-the-art laboratory instruments and expert trainers, providing training to MSc students, research scholars, and students from affiliated colleges. Upon completing the training, students will receive assured employment opportunities at Aurobindo Pharma.
Professor Rajashekar expressed the university’s readiness to host national and international events in partnership with the Survey of India, highlighting the institution’s commitment to promoting research and collaboration. The signing of these MoUs is expected to have a positive impact on the students of Andhra University, providing them with enhanced employment and research opportunities. The partnerships will not only benefit the students but also contribute to the growth and development of the region. With these agreements, Andhra University has taken a significant step towards becoming a hub for research and innovation, and is poised to make a meaningful impact in the fields of geospatial technologies and pharmaceuticals.
The Delhi High Court has ruled that a lawsuit filed by Sun Pharma is admissible, citing the company’s online presence as a relevant factor.
The Delhi High Court has ruled that a lawsuit filed by Sun Pharmaceutical Industries against a company selling a product called “PEPFIX-NEOVITAL” is maintainable. The court’s decision was based on the fact that the defendant company has an online presence, which suggests that it is doing business in the Delhi territory.
The lawsuit was filed by Sun Pharma, which claimed that the defendant company was infringing on its trademark by selling a product with a similar name. The defendant company had argued that the court did not have jurisdiction to hear the case, as it was not doing business in Delhi.
However, the court rejected this argument, citing the fact that the defendant company has a website and is selling its products online. The court noted that the website is accessible to customers in Delhi, and that the defendant company is therefore doing business in the territory.
The court’s decision is significant, as it highlights the importance of online presence in determining jurisdiction in intellectual property cases. The ruling suggests that companies with an online presence can be considered to be doing business in a particular territory, even if they do not have a physical presence there.
The case is also notable for its implications for trademark law in India. The court’s decision suggests that companies must be careful to ensure that their online activities do not infringe on the trademarks of other companies. The ruling also highlights the need for companies to be aware of their online presence and to take steps to protect their intellectual property rights in the digital sphere.
In its ruling, the court noted that the defendant company’s website is accessible to customers in Delhi, and that the company is therefore subject to the jurisdiction of the Delhi High Court. The court also noted that the defendant company’s online activities are sufficient to establish a “commercial connection” with the territory, which is a requirement for establishing jurisdiction.
Overall, the Delhi High Court’s ruling in the PEPFIX-NEOVITAL case is an important development in the field of intellectual property law in India. The decision highlights the importance of online presence in determining jurisdiction and the need for companies to be aware of their online activities and to take steps to protect their intellectual property rights.
Andhra University Signs Two Memoranda of Understanding to Foster Research and Employment Opportunities
Andhra University (AU) has taken a significant step towards enhancing its research capabilities and improving student employability by signing two Memorandums of Understanding (MoUs) with Aurobindo Pharma Foundation and the Survey of India. The partnerships aim to provide students with advanced training, research opportunities, and job placements.
The 10-year MoU with Aurobindo Pharma Foundation will lead to the establishment of a Skill Development Centre in the university’s Department of Chemistry. The centre will be equipped with state-of-the-art laboratory instruments and will provide training to MSc students, research scholars, and students from affiliated colleges. The programme will offer assured employment opportunities at Aurobindo Pharma to those who complete the training. The foundation will manage the installation, maintenance, and provide expert trainers for the centre.
On the other hand, the 5-year MoU with the Survey of India will focus on collaboration in geospatial technologies. The partnership will include joint research, internships, academic support, and information exchange. Survey of India staff will be eligible to pursue ME, MTech, and PhD programmes at AU, while university students will gain internship opportunities at the National Institute for Geo-information and Technology. Both institutions will jointly conduct conferences, workshops, and skill-development programmes.
According to Prof. G.P. Rajashekar, Vice-Chancellor of AU, the collaboration with Survey of India will provide expert guidance to AU researchers, and the university is ready to host national and international events. The partnerships are expected to strengthen the university’s research output and improve student employability, providing a significant boost to career opportunities. Overall, the MoUs demonstrate AU’s commitment to fostering industry-academia collaborations and enhancing the skills and knowledge of its students.
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