Latest news with #NCE
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Business Standard
20 hours ago
- Business
- Business Standard
Orchid Pharma hits 5% upper circuit in trade; why is the stock in demand?
Orchid Pharma shares were locked in a 5 per cent upper circuit at ₹740.1 per share on BSE. At 12:51 PM, Orchid Pharma share price was trading 4.99 per cent higher at ₹740.1 per share on BSE. In comparison, the BSE Sensex was up 0.02 per cent at 81,495.15. The market capitalisation of the company stood at ₹3,753.72 crore. The 52-week high of the company stood at ₹1,998 per share, and the 52-week low was at ₹603.8. Why were Orchid Pharma shares buzzing in trade? The buying interest on the counter came after the company entered into an agreement with the Insolvency Administrator of Allecra Therapeutics GmbH, Germany, to purchase all assets, including intellectual property, trademarks, customer contracts, regulatory filings, and other tangible and intangible assets. "This is to inform you that Orchid Pharma Limited has.. entered into an agreement with the Insolvency Administrator of Allecra Therapeutics GmbH (Germany) to purchase all assets (intellectual property, trademarks, customer contracts, regulatory filings, and tangible/intangible assets) of Allecra Therapeutics GmbH (Germany) subject to condition precedents being fulfilled by the parties to the agreement," the filing read. Separately, in France, Orchid's binding bid for the acquisition of assets—including IP rights and trademarks—of Allecra Therapeutics SAS has been accepted by the Court in a hearing held on July 30, 2025. A formal order is expected shortly. Once both transactions are completed, Orchid Pharma will consolidate 100 per cent ownership and control of Enmetazobactam globally, unifying rights that were previously distributed across separate legal entities. This marks the full repatriation of India's first novel antibiotic molecule back to the country. Enmetazobactam, when combined with cefepime, is primarily used to treat complicated urinary tract infections (cUTIs) and kidney infections (pyelonephritis) caused by certain susceptible bacteria The strategic acquisitions are expected to significantly enhance Orchid's international growth prospects and reinforce its global brand presence, while delivering meaningful financial benefits. About Orchid Pharma Orchid Pharma spans the entire pharmaceutical value chain with established credentials in research, manufacturing, and marketing. Orchid is the only Indian pharmaceutical company to have invented a New Chemical Entity (NCE, also colloquially called New Drug). The molecule is out-licensed (on a Royalty model) and is now approved in the US and Europe.
Time of India
6 days ago
- Business
- Time of India
Laurus Labs posts sharp rise in net profit for Q1FY26
Hyderabad: Pharma player Laurus Labs has posted a significant 1,154% rise in net profit for the quarter ended June 30, 2025, at Rs 163 crore compared to just Rs 13 crore in the same quarter of the previous year. This was on a 31% rise in revenue for Q1FY26 at Rs 1,570 crore from Rs 1,195 crore in Q1FY25. The company attributed the growth in revenue and profitability to an increase in revenue from the contract development and manufacturing organisation (CDMO) division, which clocked a 103% growth boosted by the delivery of several new chemical entity (NCE) projects and ramp-up from new manufacturing assets. Revenues of the generics division also grew by 12%, partly due to increased formulation sales in both antiretroviral and developed markets, it added. The company said it already commenced construction of a new gene and antibody drug conjugate (ADC) facility in Hyderabad and a microbial fermentation facility in Vizag. You Can Also Check: Hyderabad AQI | Weather in Hyderabad | Bank Holidays in Hyderabad | Public Holidays in Hyderabad Laurus Labs founder & CEO Dr Satyanarayana Chava said growth was driven by the increasing contribution from the CDMO business and continued advancement of pipeline projects, supported by generic FDF. He said the company commenced construction of various facilities across CDMO, generics, and FDF.
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Business Standard
18-07-2025
- Business
- Business Standard
CDSCO revises export NOC guidance document for new drug formulations
The Central Drugs Standard Control Organisation (CDSCO) has revised its guidance document for issuing no-objection certificates (NOCs) for the manufacture of approved or unapproved new drugs intended exclusively for export. The updated framework, previously notified in May this year, introduces relaxations for fixed-dose combinations (FDCs) and research-oriented drug batches. As part of the revised document, manufacturers of unapproved FDCs will now be allowed to submit regulatory approvals from Stringent Regulatory Authorities (SRAs) such as the United States (US), European Union (EU), Canada, Australia and Japan as an alternative to approvals from the National Regulatory Authority (NRA) of the importing country. Earlier, an NRA approval was mandatory for unapproved FDCs, new drugs under the Narcotic Drugs and Psychotropic Substances (NDPS) category, and banned drugs. The updated guideline also permits the submission of SRA approvals in cases where NRA clearance of the importing country is not available, easing the regulatory burden on Indian pharmaceutical exporters catering to international markets with more advanced drug oversight systems. The revised guidance also entails discontinuation of quantity and purchase order (PO)-specific NOCs for all classes of drugs, except for NDPS and banned drugs. The apex regulatory body also clarified that exporters of New Chemical Entity (NCE) batches for research purposes can now submit International Union of Pure and Applied Chemistry (IUPAC) names, and standard temperature and pressure (STP) data, if NRA approval of the importing country is not available. The previous document provided this option to NCE batches for clinical trials and Abbreviated New Drug Applications (ANDAS), but did not elaborate on providing the same for other NCE research activities. In May this year, the CDSCO formalised a two-step process for securing export NOCs, with the first step involving a one-time registration at the CDSCO zonal office, submission of legal documents, manufacturing licenses, reconciliation data, and regulatory approvals. The second step entailed clearance of consignments at the port office through online submission of export documents. Each NOC will be valid for one year or until the approved export quantity is exhausted, whichever comes first. The CDSCO has also set a seven-day timeline for NOC issuance under the new system. The revised guidance document for issuance of NOC for manufacture of unapproved and new drugs comes after the CDSCO had centralised this process in July last year. These powers were earlier delegated to State and Union Territory (UT) Licensing Authorities, before the apex drug regulator had withdrawn them over complaints of non-compliance of rules in issuing export NOCs. The CDSCO had also asked states to hand over all NOCs issued from August 20, 2018 to May 14, 2024 to it.
Daily Express
18-07-2025
- Politics
- Daily Express
Parti Kerjasama Anak Negeri: Table Native Courts Enactment before polls
Published on: Friday, July 18, 2025 Published on: Fri, Jul 18, 2025 By: Jinni Juanis Text Size: Trevor said NCE is rooted in cultural identity, native customs and indigenous dignity. Tuaran: Parti Kerjasama Anak Negeri (PKAN) urged the tabling of the Native Courts Enactment 2025 (NCE 2025) to recognise the Native Courts as an equal and functional part of Sabah's justice system. Its Sec-Gen Trevor Maringking said NCE is rooted in cultural identity, native customs and indigenous dignity. Advertisement 'Our party is very concerned over the continued uncertainty surrounding the tabling of the Native Courts Enactment, particularly as the review process by relevant state departments is understood to have been completed and the draft ready for presentation. 'With the current term of the State Legislative Assembly concluding before end of year, the absence of any official confirmation regarding the tabling of the NCE is deeply troubling and unacceptable,' he said. He recalled that in 2024, the Sabah Government publicly announced the establishment of a Native Judicial Department as part of its initiative to elevate the Native Courts to a status equal to the civil and syariah courts. This commitment again was reaffirmed by the Chief Minister during the Kaamatan Festival launching in Tambunan on May 1, where the announcement was met with a thunderous applause. 'Their applause is a clear reflection of the strong grassroots support and the deep cultural importance of the Native Court institution to the anak negeri communities,' said Trevor. However, he said, despite these public commitments, the Ministry of Local Government and Housing and its Minister remained silent. There were no clear direction or timeline regarding implementation of these initiatives, which are evidently in the best interest of Sabah's indigenous population. The proposed NCE aims to replace the out-dated Native Courts Enactment 1992 with a more robust structure, expanded jurisdiction and institutional reforms. 'This will finally recognise the Native Courts as an equal and functional part of Sabah's justice system which is rooted in cultural identity, native customs and indigenous dignity,' he added. Previously, party President Datuk Henrynus Amin had demanded for a clearer legal definition of 'Sabah native,' while Dr Edwin Bosi, the party's West Coast Coordinator, highlighted the alarming condition of the Native Court Training Institute. With this latest call for immediate tabling of the NCE, PKAN continues to push for meaningful institutional reform and rejects any complacency on the part of the Government in this matter. 'PKAN wishes to make it clear: speeches are no substitute for legislation. The empowerment of the Native Courts institution requires legal recognition and not political rhetoric. 'Any further delay or reluctance to table this landmark enactment will erode public confidence and may be perceived as a betrayal of the aspirations of Sabah's indigenous communities,' he stressed. PKAN also pointed to the precedent set by previous administration, which boldly established a Ministry of Law and Native Affairs. Trevor said the party was committed to advocating for such a ministry to be revived by the next government. He stressed that the failure by the current administration to act on its publicly declared initiatives or to match the past government's commitment will be seen as a serious regression in the development of native rights and governance. The party also calls on all native leaders' representatives, especially those from the ruling coalition, that they must unite to honour all publicly announced commitments made by the Government and to fulfil their moral and political responsibility. Trevor urged them to stand with their communities by ensuring that the Native Courts institution is strengthened and legally empowered as promised, especially in this important year. 'PKAN will continue to monitor this matter closely and will not remain silent. 'We will ensure that the voices and aspirations of the anak negeri communities are heard until the Native Courts Enactment 2025 is tabled and passed and the dignity of the Native Courts institution is restored to its rightful place in Sabah's judicial landscape,' he said. * Follow us on our official WhatsApp channel and Telegram for breaking news alerts and key updates! * Do you have access to the Daily Express e-paper and online exclusive news? Check out subscription plans available. Stay up-to-date by following Daily Express's Telegram channel. Daily Express Malaysia
Time of India
08-07-2025
- Business
- Time of India
Anthem Biosciences IPO: Rs 3,395 crore IPO to open on July 14
The initial public offering (IPO) of Anthem Biosciences will open for subscription on Monday, July 14. The Bengaluru-based CRDMO player is planning to raise Rs 3,395 crore through the issue. The issue will conclude on Wednesday, July 16. About Anthem Biosciences IPO The IPO is an Offer for Sale (OFS) and comprises stake sale aggregating up to Rs 350 crores each by Ganesh Sambasivam and K Ravindra Chandrappa who are promoter selling shareholders. Up to Rs 1,325 crores will be offloaded by Viridity Tone LLP and up to Rs 320 crores by Portsmouth Technologies LLC (Investor Selling Shareholders). by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Free P2,000 GCash eGift UnionBank Credit Card Apply Now Undo It also includes stake sales of Rs 320 crores each by Malay J Barua, Rupesh N Kinekar and Satish Sharma, up to Rs 80 crore by Prakash Kariabettan and up to Rs 10 crore by K Ramakrishnan. About Anthem Biosciences Anthem's business comprises Contract Research, Development and Manufacturing Organization (CRDMO) services and the manufacture and sale of specialty ingredients. It offers a comprehensive, integrated and highly customizable range of CRDMO services across the New Chemical Entity (NCE) and New Biological Entity (NBE) lifecycles. The company claims to have a strong presence across various modalities, such as RNAi, ADC, peptides, lipids and oligonucleotides, and manufacturing techniques, such as flow chemistry, enzymatic processes, biocatalysis and fermentation, offering a broad range of technology capabilities for drug development. It also manufactures and sells complex specialized fermentation-based Active Pharmaceutical Ingredients (APIs), including probiotics, enzymes, peptides, nutritional actives, vitamin analogues and biosimilars. Live Events Ajay Bhardwaj (Chairman, MD & CEO), Ganesh Sambasivam (Whole-time Director and Chief Scientific Officer), K Ravindra Chandrappa (Whole-time Director and Chief Operating Officer) and Ishaan Bhardwaj (Vice President) are the Promoters of the company. The company, which was incorporated in 2006, has two operational manufacturing facilities in India, Unit I (Bommassandra) and Unit II (Harohalli), both in Karnataka, with an aggregate annual custom synthesis capacity of 270 kL and fermentation capacity of 142 kL, as of March 31, 2025. According to the RHP, the company is in the process of expanding its custom synthesis capacity at Unit II (Harohalli) by 130 kL as well as expanding its custom synthesis capacity by 25kL and fermentation capacity by 40kL by constructing Unit III (Neoanthem Lifesciences Private Limited, wholly-owned Subsidiary), both expected to be fully operational by the first half of Fiscal 2026. Post-expansion activities, the aggregate annual custom synthesis capacity and fermentation capacity is expected to increase to 425 kL and 182 kL, respectively. The fermentation capacity of 182 kL is expected to be more than six times the capacity of the second largest player in this industry, according to the F&S Report. Anthem Biosciences financials Its revenue from operations increased by 30% to Rs 1,844 crores in FY25 from Rs 1,419 crores in FY24. The PAT for the year ended March 31, 2025 was Rs 451 crores, a jump of 22.86% over FY24. Sai Life Sciences Limited, Syngene International Limited , Cohance Lifesciences Limited , (Formerly Suven Pharmaceuticals) and Divi's Laboratories Limited are the listed peers of Anthem Biosciences, as per its RHP. Anthem Biosciences lead managers The Book Running Lead Managers to the offer are JM Financial Limited , Citigroup Global Markets India Private Limited, J.P. Morgan India Private Limited and Nomura Financial Advisory and Securities (India) Private Limited. The equity shares are proposed to be listed on BSE and NSE.
