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    Bachem Reports Slight H1 2024 Sales Growth And Confirms Full-Year Outlook

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    Incident On Construction Site Of Bachem In Bubendorf

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    Voices On Bachem’S Innovation Culture

    30 Apr 2024

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    Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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    About

    With more than 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide, providing a wide range of services. Over the years, Bachem has established itself as a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company is headquartered in Switzerland and has offices in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.

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    Bachem AGSwitzerland Flag
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    Switzerland
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    Hauptstrasse 144, 4416 Bubendorf
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    +41 585952021
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    sales.ch@bachem.com
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    https://www.bachem.com/
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    Europe, Africa, Middle East & India

    Bachem AG

    Hauptstrasse 144

    4416 Bubendorf

    Switzerland
    Tel +41 58 595 2021 (General inquiries)

    Tel +41 58 595 2020 (Sales department)

    Fax +41 58 595 2040
    Email sales.ch@bachem.com
    Contact Us: https://go.bachem.com/l/919193/2023-04-26/2dqqpk

    Americas

    Bachem Americas, Inc.

    3132 Kashiwa Street

    Torrance, CA 90505

    USA
    Tel +1 888 422 2436

    +1 888 4 BACHEM

    +1 310 539 4171

    Fax +1 310 539 9428
    Email sales.us@bachem.com
    Contact Us: https://go.bachem.com/l/919193/2023-04-26/2dqqpk

    Asia Pacific

    Bachem Japan K.K.
    Nihonbashi Life Science Building 7, 8F
    1-9-10 Nihonbashi-Horidome cho, Chuo-ku

    Tokyo 103-0012
    Japan
    Tel +81 3 6661 0774
    Email sales.jp@bachem.com

    Contact Us: https://go.bachem.com/l/919193/2023-04-26/2dqqpk 

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    CPhI Worldwide, Milan

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    Product List 2024

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    Corporate Presentation

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    Scientific Expertise to Spring 2024 Conferences

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    Leading the Octreotide Scale-up

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    Oligo Therapeutics 2024

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    Innovations for Tides 2024

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    GMP Certificate 2023

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    Gorerelin Leuprorelin Triptorelin 2024

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    Commercial Peptide NCE 2024

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    Molecular Hiving™ Technology

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    Semaglutide 2024

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    Lanreotide

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    Back to Stirred Vessels & On to Metric Tons of Oligonucleotides

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    Increasing Sustainability in Large Scale Peptide API Purification

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    Solid Phase Peptide Synthesis 2023

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    Purification- A Bottleneck for Oligonucleotide API Manufacturing

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    Manufacturing Complex Peptide APIs

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    Interview with Gilles Parmentier

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    Leadership Perspectives: Embracing Equity on Women’s Day

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    Annual General Meeting 2023

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    Innovative Approaches for Large-scale Peptide Production

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    Sustainability at Bachem

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    In Vitro Diagnostic Peptides 2023

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    Work Order for the Delivery of Large Volumes of Peptides

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    Inspiring Today’s Youth for Science and Technology

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    DATA COMPILATION #PharmaFlow

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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik.View CDMO Activity Tracker for H1 2024 (Free Excel Available) Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services.View CDMO Activity Tracker for H1 2024 (Free Excel Available)  Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs.View CDMO Activity Tracker for H1 2024 (Free Excel Available)  EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal.View CDMO Activity Tracker for H1 2024 (Free Excel Available)  Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines. 
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    FDA approves four oligonucleotide therapies in 2023; Novartis, GSK, Novo bet big

    FDA approves four oligonucleotide therapies in 2023; Novartis, GSK, Novo bet big

    In the intricate world of molecular biology, oligonucleotides stand out as versatile, powerful molecules. Oligonucleotides are essentially short, single strands of DNA or RNA that modulate gene expression. There are various oligonucleotide therapy (ONT) agents (such as antisense, deoxyribozymes, siRNA and CRISPR/Cas) that offer promising therapeutic tools.A variation of gene therapy, oligonucleotide gene therapies (OGTs) are manufactured using synthetic oligonucleotides. These therapies are designed to enter cells. ONTs act like tools that can fine-tune the behavior of certain genetic instructions, and are therefore often designed to treat rare and genetic diseases and cancers. Sometimes, they may be delivered into cells through lipid nanoparticles or adeno-associated viruses (AAV), halting the translation of a specific protein. Oligonucleotides have also revolutionized vaccine development through the creation of nucleic acid vaccines, such as mRNA vaccines.The first oligonucleotide drug, known as fomivirsen, was approved by the US Food and Drug Administration (FDA) back in 1998. It was developed by Ionis Pharmaceuticals (then known as Isis Pharmaceuticals), and was approved to treat a rare eye disease. However, ONT approvals have picked up since 2016. Currently, there are 20 oligonucleotide drugs approved by the FDA and the European Medicines Agency (EMA) and a majority of them treat orphan and rare diseases.In 2023, FDA approved four ONTs — AstraZeneca-Ionis’ Wainua (eplontersen), Novo Nordisk owned Dicerna Pharmaceuticals’ Rivfloza (nedosiran), Biogen-Ionis’ Qalsody (tofersen) and Iveric Bio’s Izervay (avacincaptad pegol).In 2021, the global ONT market size was estimated to be US$ 18.2 billion. It is expected to increase to US$ 51.4 billion by 2029, growing at a compounded annual rate (CAGR) of 13.85 percent. Similarly, the market for oligonucleotides synthesis (or the process of producing oligonucleotides) was estimated at US$ 7.7 billion globally in 2022 and is expected to grow 11.8 percent CAGR to reach US$ 16.4 billion by 2030. Some of the bigger players in oligonucleotides synthesis are Danaher Corporation, Thermo Fisher Scientific, Merck KGaA, Eurofins, Agilent, Bio-Synthesis, EUROAPI, Eurogentec, STA Pharma, and Bachem.View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available)ONTs address neuro disorders; four ONTs bring in US$ 1.24 bn for AlnylamONTs are widely applied to treat neurodegenerative diseases, such as Duchenne muscular dystrophy (DMD). Multiple ONTs have been approved in Europe and the US for DMD, such as Exondys 51 (eteplirsen), Vyondys 53 (golodirsen), and Amondys 45 (casimersen) from Sarepta and NS Pharma’s Viltepso (viltolarsen). Last year, Ionis bagged two approvals in the space. FDA approved its Biogen-partnered therapy Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS). The agency also approved AstraZeneca and Ionis’ drug Wainua (eplontersen), rendering it as the first self-administered treatment for a rare nerve damage disease, known as hereditary transthyretin amyloidosis (ATTR-PN). Analysts estimate global peak sales for Wainua to come in at US$ 750 million for ATTR-PN alone. The drug is also being tested for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), a rare heart muscle disorder.Alnylam Pharmaceuticals has also successfully brought four ONTs to market in recent years — Onpattro (patisiran) and Amvuttra (vutrisiran) for rare nerve diseases, and Givlaari (givosiran) and Oxlumo (lumasiran). Givlaari has been approved to treat acute hepatic porphyria (a liver enzyme deficiency) while Oxlumo treats primary hyperoxaluria (a disorder characterized by increased urinary oxalate excretion). The four ONTs brought in US$ 1.24 billion for Alnylam in 2023.View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available) Novartis buys rights to siRNA therapy, GSK bets big on ONT pipeline through dealsAfter Alnylam discovered inclisiran (Leqvio), Novartis acquired global rights to the therapy in a US$ 9.7 billion deal. Leqvio was the first FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction. It brought in US$ 355 million for Novartis in 2023.GSK has increasingly been investing in its ONT pipeline. The British pharma has promised over US$ 5 billion in upfront and milestone payments in multiple deals. In February, GSK exercised its option to license Elsie Biotechnologies’ discovery platform to find and develop novel ONTs. GSK has also entered a discovery collaboration with Wave Life Sciences.Last July, Japanese drugmaker Astellas Pharma completed its approximately US$ 5.9 billion buyout of New Jersey-headquartered Iveric Bio. Iveric focuses on retinal diseases and the deal gives Astellas drug candidates to treat about 160 million people with eye ailments. Subsequently, in August, Iveric’s Izervay (avacincaptad pegol) was approved by the FDA as a new treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).After Novo Nordisk acquired RNAi technology company Dicerna Pharmaceuticals for US$ 3.3 billion in 2021, the latter’s once-monthly RNAi therapy Rivfloza (nedosiran) saw FDA approval last October. Rivfloza was okayed for children nine years and older to treat a rare genetic condition that affects the kidneys, known as primary hyperoxaluria type 1 (PH1).View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available) Ionis tees up NDAs for rare disease treatments after two late-stage trial winsThe industry is looking for cures to a wide spectrum of diseases like cancer (such as melanoma, pancreatic, liver, glioblastoma, breast and ovarian cancer), cystic fibrosis, Alzheimer’s disease, Parkinson’s disease, hepatitis B, asthma, Rett syndrome, non-alcoholic steatohepatitis, and IgA nephropathy through its research on ONTs.In January, Ionis announced late-stage results wherein its RNA-targeted hereditary angioedema (HAE) candidate, donidalorsen, significantly reduced the rate of HAE attacks in patients treated every four weeks and patients treated every eight weeks. The California-based biotech is readying a new drug application (NDA) to submit to the FDA. HAE is a rare and life-threatening genetic disease that causes unpredictable and frequent severe swelling of the skin, gastrointestinal (GI) tract, upper respiratory system, face and throat. This year, Ionis’ olezarsen was granted fast track designation by the FDA for the rare genetic disease familial chylomicronemia syndrome (FCS). Last September, olezarsen had met its primary endpoint of reducing abnormally high levels of triglycerides in a late-stage trial in patients with the metabolic disorder. Currently, there are no FDA-approved treatments for this condition. If okayed, olezarsen is likely to bring in US $849 million in sales for Ionis by 2032.In March, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to two in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent (TD) anemia in certain adult patients with myelodysplastic syndromes. The agency assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2024, for Geron’s NDA for imetelstat. It is among the most anticipated drug launches this year.View Our Interactive Dashboard on Oligonucleotide Therapies (Free Excel Available) Our viewDeveloping ONTs is a field fraught with challenges, such as toxicity and drug delivery. There are safety concerns as well as concerns around delivering the therapy. However, technological breakthroughs and collaborations between pharma firms and contract research organizations that focus on drug delivery are continuously working towards addressing these challenges. All in all, we foresee exciting times ahead for ONTs.  
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    21 Mar 2024
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    NEWS #PharmaBuzz

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    Bachem Reports Slight H1 2024 Sales Growth And Confirms Full-Year Outlook
    Bachem Reports Slight H1 2024 Sales Growth And Confirms Full-Year Outlook

    25 Jul 2024

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    https://www.bachem.com/news/bachem-with-slight-sales-growth-in-the-first-half-of-2024-outlook-confirmed-for-full-year/

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    25 Jul 2024
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    Incident On Construction Site Of Bachem In Bubendorf
    Incident On Construction Site Of Bachem In Bubendorf

    28 May 2024

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    https://www.bachem.com/news/incident-on-construction-site-of-bachem-in-bubendorf/

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    28 May 2024
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    Voices On Bachem’S Innovation Culture
    Voices On Bachem’S Innovation Culture

    30 Apr 2024

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    https://www.bachem.com/news/voices-on-bachems-innovation-culture/

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    30 Apr 2024
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    Bachem Annual General Meeting 2024
    Bachem Annual General Meeting 2024

    24 Apr 2024

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    https://www.bachem.com/news/bachem-annual-general-meeting-2024/

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    24 Apr 2024
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    Streamlining Project Management For Successful Pharma Clinical Trials
    Streamlining Project Management For Successful Pharma Clinical Trials

    15 Mar 2024

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    https://www.bachem.com/peptides/streamlining-project-management-in-pharmaceutical-manufacturing-a-guide-to-successful-clinical-trials/

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    15 Mar 2024
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    Bachem continues to grow and increases dividend
    Bachem continues to grow and increases dividend

    07 Mar 2024

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    https://www.bachem.com/news/bachem-continues-to-grow-and-increases-dividend/

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    07 Mar 2024
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    ALL APIs

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    01

    Calcitonin

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Boulder Peptide 2024
    Presentation on Day 3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-03-27

    Pay. Date : 2015-03-18

    DMF Number : 6504

    Submission : 1986-07-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-180 - Rev 01

    Issue Date : 2008-08-01

    Type : Chemical

    Substance Number : 471

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10953

    Registrant's Address : 3132 Kashiwa Street, Torrance, California 90505, USA

    Initial Date of Registration : 2006-11-24

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52416-111

    Start Marketing Date : 2009-06-08

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    02

    Carbidopa

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Boulder Peptide 2024
    Presentation on Day 3
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-07-11

    Pay. Date : 2013-06-17

    DMF Number : 9231

    Submission : 1991-07-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-012 - Rev 08

    Issue Date : 2019-12-16

    Type : Chemical

    Substance Number : 755

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10146

    Registrant's Address : Route du simplon 22, CH-1895 Vionnaz-Switzerland

    Initial Date of Registration : 2010-04-22

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51504-0001

    Start Marketing Date : 1991-07-11

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kookjeon Pharmaceutical Co., Ltd.

    Registration Date : 2021-03-03

    Registration Number : 20210303-211-J-655

    Manufacturer Name : Bachem S.A.

    Manufacturer Address : Succursale of Vionnaz, Route du Simplon 22, 1895 Vionnaz, Switzerland

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    03

    Desmopressin Acetate

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-03-31

    Pay. Date : 2014-03-27

    DMF Number : 9951

    Submission : 1992-11-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2007-157 - Rev 02

    Issue Date : 2023-06-29

    Type : Chemical

    Substance Number : 712

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10051

    Registrant's Address : 3132 Kashiwa Street, Torrance, California 90505, USA

    Initial Date of Registration : 2014-02-27

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 52416-108

    Start Marketing Date : 2001-09-27

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : EXPORT ONLY

    KDMF VMF Others AUDIT
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    04

    Goserelin Acetate

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-03-12

    Pay. Date : 2019-11-29

    DMF Number : 34363

    Submission : 2019-12-19

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-037 - Rev 03

    Issue Date : 2020-12-18

    Type : Chemical

    Substance Number : 1636

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 304MF10160

    Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland

    Initial Date of Registration : 2022-12-23

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 55463-0005

    Start Marketing Date : 2003-11-25

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Leuprolide Acetate

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-09-02

    Pay. Date : 2016-04-29

    DMF Number : 13822

    Submission : 1998-11-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2001-454 - Rev 01

    Issue Date : 2009-02-18

    Type : Chemical

    Substance Number : 1442

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10137

    Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland

    Initial Date of Registration : 2010-04-14

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 55463-0002

    Start Marketing Date : 2001-11-01

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hiple Co., Ltd.

    Registration Date : 2022-12-07

    Registration Number : 20221207-210-J-1398

    Manufacturer Name : Bachem AG

    Manufacturer Address : Hauptstrasse 144, 4416 Bubendorf, Switzerland

     VMF Others AUDIT
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    06

    Propofol

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-14

    Pay. Date : 2012-12-18

    DMF Number : 11204

    Submission : 1994-11-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2005-003 - Rev 04

    Issue Date : 2023-11-27

    Type : Chemical

    Substance Number : 1558

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10007

    Registrant's Address : Route du simplon 22, CH-1895 Vionnaz-Switzerland

    Initial Date of Registration : 2009-01-13

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Daewon Pharmaceutical Co., Ltd.

    Registration Date : 2023-02-15

    Registration Number : 20200806-210-J-463(4)

    Manufacturer Name : Bachem S.A.

    Manufacturer Address : Succursale of Vionnaz, Route du Simplon 22, 1895 Vionnaz, Switzerland

     VMF Others AUDIT
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    07

    Etomidate

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-10-16

    Pay. Date : 2014-10-14

    DMF Number : 20234

    Submission : 2007-01-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2020-417 - Rev 00

    Issue Date : 2022-05-06

    Type : Chemical

    Substance Number : 1514

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51504-0012

    Start Marketing Date : 2007-01-29

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Bachem company banner

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    08

    Glucagon

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-05-07

    Pay. Date : 2015-04-27

    DMF Number : 18277

    Submission : 2005-04-12

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 231MF10022

    Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland

    Initial Date of Registration : 2019-01-29

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 55463-0009

    Start Marketing Date : 2005-03-10

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    09

    Glucagon

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32703

    Submission : 2018-06-08

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10708

    Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland

    Initial Date of Registration : 2006-08-11

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 55463-0009

    Start Marketing Date : 2005-03-10

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    10

    Icatibant Acetate

    Switzerland

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20862

    Submission : 2007-09-17

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 229MF10071

    Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland

    Initial Date of Registration : 2017-04-04

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 55463-0033

    Start Marketing Date : 2007-09-17

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    Product
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    USDMF

    read-more
    read-more

    01

    5-aminolevulinic Acid Hydrochloride

    Switzerland
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 9972

    Submission : 1992-11-25

    Status : Active

    Type : II

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    02

    Ac-137

    Switzerland
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    Bachem AG

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10068

    Submission : 1993-02-04

    Status : Active

    Type : II

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    03

    Bivalirudin

    Switzerland
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    Bachem AG

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31458

    Submission : 2017-03-31

    Status : Active

    Type : II

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    04

    Carbidopa

    Switzerland
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-07-11

    Pay. Date : 2013-06-17

    DMF Number : 9231

    Submission : 1991-07-11

    Status : Active

    Type : II

    Bachem company banner

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    05

    Desmopressin Acetate

    Switzerland
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    Bachem AG

    GDUFA

    DMF Review : Complete

    Rev. Date : 2017-03-31

    Pay. Date : 2014-03-27

    DMF Number : 9951

    Submission : 1992-11-05

    Status : Active

    Type : II

    Bachem company banner

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    06

    Etomidate

    Switzerland
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    Bachem AG

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-10-16

    Pay. Date : 2014-10-14

    DMF Number : 20234

    Submission : 2007-01-29

    Status : Active

    Type : II

    Bachem company banner

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    07

    Etomidate Process B

    Switzerland
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    Bachem AG

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-12-12

    Pay. Date : 2023-09-22

    DMF Number : 38855

    Submission : 2023-09-19

    Status : Active

    Type : II

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    08

    Exenatide (bulk)

    Switzerland
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    Bachem AG

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-03-21

    Pay. Date : 2013-09-16

    DMF Number : 17227

    Submission : 2004-03-05

    Status : Active

    Type : II

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    09

    Glucagon

    Switzerland
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    Bachem AG

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-05-07

    Pay. Date : 2015-04-27

    DMF Number : 18277

    Submission : 2005-04-12

    Status : Active

    Type : II

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    10

    Glucagon Pharma Grade

    Switzerland
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    Bachem AG

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32703

    Submission : 2018-06-08

    Status : Active

    Type : II

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    ABOUT THIS PAGE

    Contact Sochinaz SA and get a quotation

    Sochinaz SA is a supplier offers 44 products (APIs, Excipients or Intermediates).

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