Dipharma Francis Srl

MILAN, Italy, May 07, 2024 (GLOBE NEWSWIRE) -- Dipharma Francis S.r.l. (Dipharma), a global Contract Development and Manufacturing Organization (CDMO) and leading manufacturer of New Chemical Entities (NCE), Generic Active Pharmaceutical Ingredients and Advanced Intermediates, proudly announced that Dipharma Inc., its US facility located in Kalamazoo, MI, has been inspected by the U.S. Food and Drug Administration (FDA) and has received the Establishment Inspection Report (EIR), satisfactorily closing the inspection process. The rigorous inspection took place in the second week of January this year. At the closing meeting the inspectors congratulated the Dipharma team members on the Current Good Manufacturing Practices (CGMP) Systems they created and their overall commitment to quality. Since 1970, Dipharma Group has achieved an unbroken positive record of inspections by the major international Regulatory Agencies, and this new achievement demonstrates the Company’s extensive experience in ensuring compliance with the highest global quality standards. With this accomplishment, Dipharma Inc. expands the range of services offered to its international clients to include commercial deliveries. Furthermore, it enhances the vertical integration of all Dipharma’s CGMP manufacturing processes, in all four facilities, from preclinical to commercial scale. "The successful closure of the FDA's Pre-Approval Inspection (PAI) marks a significant achievement for our US facility, Dipharma Inc.Congratulations to the whole team for this great accomplishment," stated Jorge Nogueira, Chief Executive Officer of Dipharma Francis. "This inspection, the first conducted by the FDA at our US facility, underscores the Dipharma Group's unwavering commitment to continuously improve our GMP Systems and uphold the highest quality standards. It reflects our dedication to ensuring that our products meet stringent quality benchmarks for patients worldwide." Dipharma Inc.’s Kalamazoo facility provides world-class CDMO services and API supplies for the Group’s pre-clinical and clinical customers. The facility has undergone significant expansion in recent years with the aim of supporting and growing its services to meet the growing demands of the U.S. market. Staffed by highly skilled employees, Dipharma Inc. is equipped with a world-class R&D laboratory and a state-of-the-art CGMP facility including a Kilolab with dedicated QC laboratory and warehouses. The latest significant investment, in 2023, added a second cutting-edge CGMP line, capable of running larger-scale reactions in the Kilolab in reactors of up to 105 L volume. With this investment, Dipharma Inc. more than triples its capacity to process projects for customers, both in the generics and CDMO arena, while enhancing operational safety and isolation technologies. About the Dipharma Francis group With revenues of €160 million, the Dipharma Group is a global CDMO and a leading manufacturer of APIs and Intermediates, with about 600 skilled and highly committed employees, 4 cGMP plants, located in the U.S.A. and Italy, plus sales offices in Italy, the U.S.A. and China. The fully equipped R&D Centers develop innovative chemical processes and crystalline forms for the most prominent pharmaceutical companies worldwide. As a third-generation family-owned company, Dipharma has a long history of stability, commitment, and financial solidity. Dipharma has the right size and variety of scale-up capabilities to act as a global player and manage processes efficiently, while offering flexibility and agility to promptly solve any challenge. Experience you can trust. For more information: Paola Clerici Communication Manager Dipharma Francis S.r.l. paola.clerici@dipharma.com A photo accompanying this announcement is available at Dipharma's researcher checking process parameters at the new cutting-edge CGMP Kilolab line Researcher checking process parameters at the new cutting-edge CGMP Kilolab line, located at Dipharma Inc., in Kalamazoo MI, USA

The Caronno Pertusella site (Italy) is the second Dipharma manufacturing facility to receive ANVISA certificationMILAN, Italy, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Dipharma Francis S.r.l. (Dipharma), a leading Contract Development and Manufacturing Organization (CDMO) and a global manufacturer of Active Pharmaceutical Ingredients, announced today another new production site of the Group, the facility located in Caronno Pertusella, near Milan (Italy), has received the Good Manufacturing Practice (GMP) certification - CBPF (Certificado de Boas Práticas de Fabricação) - from the Regulatory Authority of Brazil, ANVISA (Agência Nacional de Vigilância Sanitária). This authorization joins the previous one, obtained in November 2022, by the Dipharma Italian site located in Baranzate (Milan), and certifies Dipharma world-class quality system, which has been widely recognized by regulatory authorities. The Caronno Pertusella facility has been regularly and successfully inspected by the US FDA and the Italian Ministry of Health (AIFA) for more than 50 years. “We are very proud to have reached another regulatory milestone: this second successful completion of the ANVISA certification recognizes another Dipharma site as being in compliance with the GMP requisites as foreseen by the Brazilian requirements,” said Jorge Nogueira, Chief Executive Officer of Dipharma Francis S.r.l. — “Our Company is committed to providing innovative and competitive solutions to our customers and this achievement once again certifies we are an ideal partner for registering new applications at ANVISA.” About the Dipharma Francis GroupWith revenues over €140 million, the Dipharma Group is a global CDMO and a leading manufacturer of APIs and Intermediates, with more than 550 skilled and highly committed employees, 4 cGMP plants, located in the U.S.A. and Italy, plus sales offices in Italy, the U.S.A. and China. The fully equipped R&D Centers develop innovative chemical processes and crystalline forms for the most prominent pharmaceutical companies worldwide. As a third-generation family-owned company, Dipharma has a long history of stability, commitment, and financial solidity. Since 1970, Dipharma has managed to achieve a positive unbroken record of inspections by the main Regulatory Agencies and its cGMP manufacturing sites are equipped to supply quantities from laboratory to industrial scale. Dipharma has the right size and variety of scale-up capabilities to act as a global player and manage processes efficiently, while offering flexibility and agility to promptly solve any challenge. Experience you can trust. For more information: Paola Clerici Communication ManagerDipharma Francis S.r.l.paola.clerici@dipharma.comwww.dipharma.com

Eli Lilly’s diabetes drug Mounjaro now seems to be available once more. According to a report from Bloomberg, the pharma giant now has doses available and is shipping them “on an ongoing basis.” However, Bloomberg’s report does state that Eli Lilly is warning that due to demand, some pharmacies may still experience shipping delays. According to the FDA’s database on drug shortages, all dosage forms of Mounjaro are presently listed as being available. The FDA stated on its database that the reason for the shortage was the demand. Toward the end of last year, the US regulator had listed tirzepatide injections as being in shortage. A report from SVB securities last year also stated that Lilly plans to double its manufacturing capacity for the drug. Merck is selling one of its old locations in the Garden State. The pharma announced that it reached an agreement with Onyx Equities, LLC to sell its 108-acre campus in Kenilworth, NJ. Merck plans to vacate the property over the next several years while its new headquarters down in Rahway will be finishing an expansion. However, no details have been given on what the site will be. According to Merck’s website, the facility is one of Merck’s main R&D centers . “We believe Onyx Equities, LLC will foster long-term value, economic growth and sustainability within the community. We look forward to collaborating with Onyx Equities, LLC and their team members on a smooth transition,” said Shefali Shah, the global real estate lead at Merck, in a release . The Italian CDMO Dipharma has finished the second phase of expansion at its facility in Kalamazoo, MI. The expansion will add more manufacturing space along with a quality control lab and warehouse space. In an email to Endpoints News, Dipharma CEO Brian Eklov said the expansion is part of a recent investment to enlarge Dipharma’s offerings in Kalamazoo and “increase proximity” to its customers in the US. Dipharma first entered the US market in 2012 and acquired a Kalamazoo-based CRO, Kalexsyn, in 2018. Eklov also detailed to Endpoints that the second phase added 2000 square feet and that the total capital investment into the Kalamazoo site is north of $6 million for all expansion projects. PackGene, a contract research and manufacturing company in the AAV vector business, has broken ground on a new biomanufacturing facility in Houston. The 25,000-square-foot facility will be located outside of downtown Houston and will include laboratories, manufacturing space, a warehouse and offices. The expansion is planned to be finished by the end of the year and will have around 60 employees. The cost of the facility was not immediately available. “These capabilities will enable us to serve our U.S. customers better and, importantly, to help bring life-saving therapies to patients faster, more reliably, and more cost-effectively. With this, we are making great strides in advancing our mission of ‘making gene therapy affordable,” said PackGene CTO LiYing Yang in a release . Canadian contract manufacturer Dalton Pharma Services is planning to expand its sterile filling and pharma manufacturing space. In a release, the company said it is boosting its capacity with a new manufacturing line to fill vials, syringes and cartridges. The expansion will allow for more manufacturing room along with the ability to produce more active pharmaceutical ingredients and more storage space. However, the cost of the expansion was not disclosed “This major investment in the expansion of our sterile manufacturing capabilities enables us to meet the needs of our customers as their critical products advance to commercialization. It also represents a leap forward in both scale and technology for us, placing Dalton at the leading edge of sterile manufacturing capabilities,” said Peter Pekos, CEO of Dalton Pharma Services in a release . The life science consultancy company USP/Pharmatech is allying to offer its expertise and capabilities to drug makers who are looking to switch to continuous manufacturing. According to a release, Pharmatech Associates, along with Integra Contiguous Manufacturing Systems, will aim to provide training, compliance and regulatory needs for any company that is looking to switch from batch to pharmaceutical continuous manufacturing (PCM). “Given our expertise and experience with PCM, the alliance of USP, Pharmatech, and Integra will bridge the knowledge gap and lower the perceived barriers to adoption and implementation to allow drug sponsors and manufacturers to realize the benefits of PCM,” said Bikash Chatterjee, Pharmatech Associates CEO, in a release . However, details on the full range of offerings or any financial details on the offering were not immediately available. CDMO GenScript ProBio will be producing plasmid DNA for the biotech RVAC Medicines, and its Covid-19 vaccine candidate dubbed RVM-V001. The release stated that the partnership extends to other therapeutics in its pipeline, including an RSV and CDI candidate. The CDMO will also offer consultation services surrounding quality and regulatory issues. However, the financial details or the amount of plasmid that GenScript is manufacturing was not disclosed. “This collaboration will enable us to utilize our cutting-edge GMP plasmid manufacturing platform technology to support the development of mRNA-based Covid-19 vaccine and its therapeutic candidates,” said GenScript CEO Brian Min, in a release . The North Carolina-based CDMO Alcami has named Katie Schlipp as president of its laboratory operations. According to the release, Schlipp has over 25 years of experience heading up lab teams. She started with AAIPharma, which is now Alcami, as an assistant scientist at its location in Wilmington, NC, and has risen through the ranks since then. As president, she will be heading up Alcami’s lab network which is spread across four locations. “Katie’s proven track record of leading client-focused laboratory operations makes her the ideal choice to lead Alcami’s next phase of laboratory operations growth and expansion,” said Alcami CEO Patrick Walsh, in a release .