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Chemistry

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Also known as: Aai101, 1001404-83-6, Aai-101, Ocid-5090, 80vun7l00c, (2s,3s,5r)-3-methyl-3-((3-methyl-1h-1,2,3-triazol-3-ium-1-yl)methyl)-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide
Molecular Formula
C11H14N4O5S
Molecular Weight
314.32  g/mol
InChI Key
HFZITXBUTWITPT-YWVKMMECSA-N
FDA UNII
80VUN7L00C

Enmetazobactam
1 2D Structure

Enmetazobactam

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,3S,5R)-3-methyl-3-[(3-methyltriazol-3-ium-1-yl)methyl]-4,4,7-trioxo-46-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
2.1.2 InChI
InChI=1S/C11H14N4O5S/c1-11(6-14-4-3-13(2)12-14)9(10(17)18)15-7(16)5-8(15)21(11,19)20/h3-4,8-9H,5-6H2,1-2H3/t8-,9+,11+/m1/s1
2.1.3 InChI Key
HFZITXBUTWITPT-YWVKMMECSA-N
2.1.4 Canonical SMILES
CC1(C(N2C(S1(=O)=O)CC2=O)C(=O)[O-])CN3C=C[N+](=N3)C
2.1.5 Isomeric SMILES
C[C@@]1([C@@H](N2[C@H](S1(=O)=O)CC2=O)C(=O)[O-])CN3C=C[N+](=N3)C
2.2 Other Identifiers
2.2.1 UNII
80VUN7L00C
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (2s,3s,5r)-3-methyl-3-((3-methyltriazol-3-ium-1-yl)methyl)-4,4,7-trioxo-4'6-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate

2. 1h-1,2,3-triazolium, 3-(((2s,3s,5r)-2-carboxy-3-methyl-4,4-dioxido-7-oxo-4-thia-1-azabicyclo(3.2.0)hept-3-yl)methyl)-1-methyl-, Inner Salt

3. Aai101

2.3.2 Depositor-Supplied Synonyms

1. Aai101

2. 1001404-83-6

3. Aai-101

4. Ocid-5090

5. 80vun7l00c

6. (2s,3s,5r)-3-methyl-3-((3-methyl-1h-1,2,3-triazol-3-ium-1-yl)methyl)-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide

7. (2s,3s,5r)-3-methyl-3-((3-methyltriazol-3-ium-1-yl)methyl)-4,4,7-trioxo-4^6-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate

8. (2s,3s,5r)-3-methyl-3-[(3-methyltriazol-3-ium-1-yl)methyl]-4,4,7-trioxo-4lambda6-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate

9. 1h-1,2,3-triazolium, 3-(((2s,3s,5r)-2-carboxy-3-methyl-4,4-dioxido-7-oxo-4-thia-1-azabicyclo(3.2.0)hept-3-yl)methyl)-1-methyl-, Inner Salt

10. Enmetazobactam [inn]

11. Unii-80vun7l00c

12. Chembl4458276

13. Schembl18110082

14. Gtpl12188

15. Bqb40483

16. Cs-7557

17. Hy-103095

18. J3.628.087e

19. D87135

2.4 Create Date
2008-01-28
3 Chemical and Physical Properties
Molecular Weight 314.32 g/mol
Molecular Formula C11H14N4O5S
XLogP3-0.6
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count6
Rotatable Bond Count2
Exact Mass314.06849073 g/mol
Monoisotopic Mass314.06849073 g/mol
Topological Polar Surface Area125 Ų
Heavy Atom Count21
Formal Charge0
Complexity597
Isotope Atom Count0
Defined Atom Stereocenter Count3
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

beta-Lactamase Inhibitors

Endogenous substances and drugs that inhibit or block the activity of BETA-LACTAMASES. (See all compounds classified as beta-Lactamase Inhibitors.)


FDF Dossiers

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Advanz Pharma

United Kingdom
BioProcess International US West
Not Confirmed
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Advanz Pharma

United Kingdom
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BioProcess International US West
Not Confirmed

Cefepimdihydrokloridmonohydrat; Enmetazobactam

Brand Name : Exblifep

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 2g; 0.5g

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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02

Advanz Pharma

United Kingdom
BioProcess International US West
Not Confirmed
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Advanz Pharma

United Kingdom
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BioProcess International US West
Not Confirmed

Cefepime; Enmetazobactam

Brand Name : Exblifep

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 2g; 0.5g

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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03

Advanz Pharma

United Kingdom
BioProcess International US West
Not Confirmed
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Advanz Pharma

United Kingdom
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BioProcess International US West
Not Confirmed

Cefepime Dihydrochloride Monohydrate; Enmetazobactam

Brand Name : Exblifep

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 2G; 0.5 G

Packaging :

Approval Date : 04-04-2024

Application Number : 1241794001

Regulatory Info : Authorized

Registration Country : Spain

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04

Advanz Pharma

United Kingdom
BioProcess International US West
Not Confirmed
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Advanz Pharma

United Kingdom
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BioProcess International US West
Not Confirmed

Cefepim Dihydrochloride Monohydrate; Cefepim Dihydrochloride Monohydrate; Enmetazobactam

Brand Name : Exblifep

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 2g; 0.5g

Packaging :

Approval Date : 21-03-2024

Application Number : 28106874822

Regulatory Info : Prescription

Registration Country : Denmark

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05

Advanz Pharma

United Kingdom
BioProcess International US West
Not Confirmed
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Advanz Pharma

United Kingdom
arrow
BioProcess International US West
Not Confirmed

Cefepime Dihydrochloride Monohydrate; Enmetazobactam

Brand Name : Exblifep

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 2g;0.5g

Packaging :

Approval Date : 21-03-2024

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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Europe

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Advanz Pharma Limited

United Kingdom
BioProcess International US West
Not Confirmed
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Advanz Pharma Limited

United Kingdom
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BioProcess International US West
Not Confirmed

Cefepimdihydrokloridmonohydrat; Enmetazobactam

Brand Name : Exblifep

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 2g; 0.5g

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

blank

02

Advanz Pharma Limited

United Kingdom
BioProcess International US West
Not Confirmed
arrow

Advanz Pharma Limited

United Kingdom
arrow
BioProcess International US West
Not Confirmed

Cefepime; Enmetazobactam

Brand Name : Exblifep

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 2g; 0.5g

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

blank

03

Advanz Pharma Limited

United Kingdom
BioProcess International US West
Not Confirmed
arrow

Advanz Pharma Limited

United Kingdom
arrow
BioProcess International US West
Not Confirmed

Cefepime Dihydrochloride Monohydrate; Enmetazobactam

Brand Name : Exblifep

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 2G; 0.5 G

Packaging :

Approval Date : 04-04-2024

Application Number : 1241794001

Regulatory Info : Authorized

Registration Country : Spain

blank

04

Advanz Pharma Limited

United Kingdom
BioProcess International US West
Not Confirmed
arrow

Advanz Pharma Limited

United Kingdom
arrow
BioProcess International US West
Not Confirmed

Cefepim Dihydrochloride Monohydrate; Cefepim Dihydrochloride Monohydrate; Enmetazobactam

Brand Name : Exblifep

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 2g; 0.5g

Packaging :

Approval Date : 21-03-2024

Application Number : 28106874822

Regulatory Info : Prescription

Registration Country : Denmark

blank

05

Advanz Pharma Limited

United Kingdom
BioProcess International US West
Not Confirmed
arrow

Advanz Pharma Limited

United Kingdom
arrow
BioProcess International US West
Not Confirmed

Cefepime Dihydrochloride Monohydrate; Enmetazobactam

Brand Name : Exblifep

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 2g;0.5g

Packaging :

Approval Date : 21-03-2024

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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DATA COMPILATION #PharmaFlow

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FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies
In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding. 

Impressions: 13071

https://www.pharmacompass.com/radio-compass-blog/fda-okays-50-new-drugs-in-2024-bms-cobenfy-lilly-s-kisunla-lead-pack-of-breakthrough-therapies

#PharmaFlow by PHARMACOMPASS
30 Jan 2025

NEWS #PharmaBuzz

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Looking for 1001404-83-6 / Enmetazobactam API manufacturers, exporters & distributors?

Enmetazobactam manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Enmetazobactam API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Enmetazobactam manufacturer or Enmetazobactam supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Enmetazobactam manufacturer or Enmetazobactam supplier.

PharmaCompass also assists you with knowing the Enmetazobactam API Price utilized in the formulation of products. Enmetazobactam API Price is not always fixed or binding as the Enmetazobactam Price is obtained through a variety of data sources. The Enmetazobactam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Enmetazobactam

Synonyms

Aai101, 1001404-83-6, Aai-101, Ocid-5090, 80vun7l00c, (2s,3s,5r)-3-methyl-3-((3-methyl-1h-1,2,3-triazol-3-ium-1-yl)methyl)-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide

Cas Number

1001404-83-6

Unique Ingredient Identifier (UNII)

80VUN7L00C

Enmetazobactam Manufacturers

A Enmetazobactam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enmetazobactam, including repackagers and relabelers. The FDA regulates Enmetazobactam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enmetazobactam API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Enmetazobactam Suppliers

A Enmetazobactam supplier is an individual or a company that provides Enmetazobactam active pharmaceutical ingredient (API) or Enmetazobactam finished formulations upon request. The Enmetazobactam suppliers may include Enmetazobactam API manufacturers, exporters, distributors and traders.

Enmetazobactam GMP

Enmetazobactam Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Enmetazobactam GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Enmetazobactam GMP manufacturer or Enmetazobactam GMP API supplier for your needs.

Enmetazobactam CoA

A Enmetazobactam CoA (Certificate of Analysis) is a formal document that attests to Enmetazobactam's compliance with Enmetazobactam specifications and serves as a tool for batch-level quality control.

Enmetazobactam CoA mostly includes findings from lab analyses of a specific batch. For each Enmetazobactam CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Enmetazobactam may be tested according to a variety of international standards, such as European Pharmacopoeia (Enmetazobactam EP), Enmetazobactam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Enmetazobactam USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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