Bachem AG DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News

Corporate Presentation

Pioneering Sustainable, Large-Scale Tides Manufacturing

Maintaining a Resilient Tides Supply Chain Under VUCA Conditions

Scientific Expertise to Spring 2024 Conferences

Leading the Octreotide Scale-up

Oligo Therapeutics 2024

Innovations for Tides 2024

GMP Certificate 2023

Gorerelin Leuprorelin Triptorelin 2024

Commercial Peptide NCE 2024

Molecular Hiving™ Technology

Semaglutide 2024

Lanreotide

Back to Stirred Vessels & On to Metric Tons of Oligonucleotides

Increasing Sustainability in Large Scale Peptide API Purification

Solid Phase Peptide Synthesis 2023

Purification- A Bottleneck for Oligonucleotide API Manufacturing

Manufacturing Complex Peptide APIs

Interview with Gilles Parmentier

Leadership Perspectives: Embracing Equity on Women’s Day

Annual General Meeting 2023

Innovative Approaches for Large-scale Peptide Production

Sustainability at Bachem

In Vitro Diagnostic Peptides 2023

Click the button for full data set

Innovation for Peptide & Oligonucleotide Manufacturing

Peptide-based In Vitro Diagnostics

Generic APIs-Liraglutide & Other GLP-1 Analogues

Oligonucleotide Facility Virtual Tour

Semaglutide

Leading by Experience in Generic API

Customer Testimonial

Continuous Chromatography of Peptides

Expanding into Oligos - Interview

Thiazine Formation: Elucidation of Thiol-Maleimide Side-Reaction

Oligonucleotides - Innovation that Transforms Lives

Interview with Torsten Wohr

The Perfect Ingredients for a Better World

Sherpany and Futurae

DATA COMPILATION #PharmaFlow

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.

Impressions: 3090

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.

Impressions: 3622

NEWS #PharmaBuzz

How to Choose the Right CDMO Partner: Key Factors to Consider

20 Nov 2024

// PRESS RELEASE

Bachem’s Sustainable TIDES Manufacturing

30 Oct 2024

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Bachem at Swiss Technology Award 2024

20 Sep 2024

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

25 Jul 2024

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Incident On Construction Site Of Bachem In Bubendorf

28 May 2024

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Voices On Bachem’S Innovation Culture

30 Apr 2024

// PRESS RELEASE

ALL APIs

01

Calcitonin

Switzerland

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

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

USDMF

Click Us!

CEP/COS

JDMF

EU-WC NDC

KDMF VMF Others AUDIT

02

Carbidopa

Switzerland

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

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

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF

VMF Others AUDIT

03

Desmopressin Acetate

Switzerland

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

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

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF VMF Others AUDIT

04

Goserelin Acetate

Switzerland

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

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

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF VMF Others AUDIT

05

Leuprolide Acetate

Switzerland

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

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

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF

VMF Others AUDIT

06

Octreotide Acetate

Switzerland

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

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

USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF VMF Others AUDIT

07

Propofol

Switzerland

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

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

USDMF

CEP/COS

JDMF

EU-WC NDC KDMF

VMF Others AUDIT

08

Etomidate

Switzerland

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

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

USDMF

CEP/COS

JDMF EU-WC NDC

KDMF VMF Others AUDIT

09

Glucagon

Switzerland

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

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

USDMF

CEP/COS JDMF

EU-WC NDC

KDMF VMF Others AUDIT

10

Glucagon

Switzerland

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

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

USDMF

CEP/COS JDMF

EU-WC NDC

KDMF VMF Others AUDIT

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USDMF

01

5-aminolevulinic Acid Hydrochloride

Switzerland

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

Bachem AG

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9972

Submission : 1992-11-25

Status : Active

Type : II

02

Ac-137

Switzerland

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

Bachem AG

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10068

Submission : 1993-02-04

Status : Active

Type : II

03

Bivalirudin

Switzerland

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

Bachem AG

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 31458

Submission : 2017-03-31

Status : Active

Type : II

04

Carbidopa

Switzerland

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

Bachem AG

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

05

Desmopressin Acetate

Switzerland

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

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

06

Etomidate

Switzerland

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

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

07

Etomidate Process B

Switzerland

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

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

08

Exenatide (bulk)

Switzerland

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

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

09

Glucagon

Switzerland

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

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

10

Glucagon Pharma Grade

Switzerland

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

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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CEP/COS

01

Calcitonin (salmon), Chemical origin

Switzerland

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

Bachem AG

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

Status : Valid

Issue Date : 2008-08-01

Type : Chemical

Substance Number : 471

02

Calcitonin (salmon), Synthetic

Switzerland

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

Bachem AG

Certificate Numbers : R1-CEP 2010-347 - Rev 00

Status : Valid

Issue Date : 2016-12-02

Type : Chemical

Substance Number : 471

03

Carbidopa

Switzerland

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

Bachem AG

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

Status : Valid

Issue Date : 2019-12-16

Type : Chemical

Substance Number : 755

04

Carbidopa, Process-II

Switzerland

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

Bachem AG

Certificate Numbers : R0-CEP 2020-364 - Rev 00

Status : Valid

Issue Date : 2021-06-22

Type : Chemical

Substance Number : 755

05

Desmopressin

Switzerland

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

Bachem AG

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

Status : Valid

Issue Date : 2023-06-29

Type : Chemical

Substance Number : 712

06

Etomidate

Switzerland

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

Bachem AG

Certificate Numbers : CEP 2005-250 - Rev 03

Status : Valid

Issue Date : 2024-03-20

Type : Chemical

Substance Number : 1514

07

Etomidate, Process B

Switzerland

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

Bachem AG

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

Status : Valid

Issue Date : 2022-05-06

Type : Chemical

Substance Number : 1514

08

Gonadorelin acetate

Switzerland

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

Bachem AG

Certificate Numbers : R1-CEP 2005-022 - Rev 01

Status : Valid

Issue Date : 2018-06-14

Type : Chemical

Substance Number : 827

09

Goserelin

Switzerland

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

Bachem AG

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

Status : Valid

Issue Date : 2020-12-18

Type : Chemical

Substance Number : 1636

10

Leuprorelin

Switzerland

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

Bachem AG

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

Status : Valid

Issue Date : 2009-02-18

Type : Chemical

Substance Number : 1442

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JDMF

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KDMF

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NDC API

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VMF

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LISTED APIs

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Analytical Method Development

01

ANALYTICAL METHOD DEVELOPMENT & ...

Switzerland

Bachem has extensive analytical expertise and offers all analytical services to ensure successful product development. Its GMP-compliant analytical capabilities include method development and validation, stability studies, nitrosamine determination, etc.

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

Pharma Service : Analytical

Bachem AG

Category : Analytical Method Development

Sub Category : Method Development and Validation

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

Pharma Service : Analytical

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

Service
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