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Chemistry

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Also known as: Fosfomycin disodium, 26016-99-9, Phosphonemycin, Fosfomycin disodium salt, Phosphomycin disodium salt, Veramina
Molecular Formula
C3H5Na2O4P
Molecular Weight
182.02  g/mol
InChI Key
QZIQJIKUVJMTDG-JSTPYPERSA-L
FDA UNII
97MMO19FNO

Fosfomycin Sodium
1 2D Structure

Fosfomycin Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
disodium;[(2R,3S)-3-methyloxiran-2-yl]-dioxido-oxo-5-phosphane
2.1.2 InChI
InChI=1S/C3H7O4P.2Na/c1-2-3(7-2)8(4,5)6;;/h2-3H,1H3,(H2,4,5,6);;/q;2*+1/p-2/t2-,3+;;/m0../s1
2.1.3 InChI Key
QZIQJIKUVJMTDG-JSTPYPERSA-L
2.1.4 Canonical SMILES
CC1C(O1)P(=O)([O-])[O-].[Na+].[Na+]
2.1.5 Isomeric SMILES
C[C@H]1[C@H](O1)P(=O)([O-])[O-].[Na+].[Na+]
2.2 Other Identifiers
2.2.1 UNII
97MMO19FNO
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Fosfomycin Disodium

2. 26016-99-9

3. Phosphonemycin

4. Fosfomycin Disodium Salt

5. Phosphomycin Disodium Salt

6. Veramina

7. Disodium Phosphonomycin

8. Disodium (1r,2s)-(1,2-epoxypropyl)phosphonate

9. Fosfomycin Sodium [jan]

10. Disodium Fosfomycin

11. Priomicina

12. Fosfomycin Sodium Salt

13. 97mmo19fno

14. Fosfocina Disodium Salt

15. Phosphonomycin Disodium Salt

16. Sodium Fosfomycin

17. Phosphonomycin Sodium

18. Phosphonic Acid, [(2r,3s)-3-methyloxiranyl]-, Disodium Salt

19. Disodium [(2r,3s)-3-methyloxiran-2-yl]phosphonate

20. Fom-na

21. Mk 955

22. Fosfocin

23. Forocyle S

24. Fosmicin S

25. Nsc-136017

26. Einecs 247-409-2

27. Unii-97mmo19fno

28. Nsc 136017

29. Levo-phosphonomycin Disodium Salt

30. (?)-fosfomycin

31. Fosmicin S (tn)

32. Phosphonemycin Disodium

33. (2r-cis)-(3-methyloxiranyl)phosphonic Acid Disodium Salt

34. (1r,2s)(-)-(1,2-epoxypropyl)phosphonic Acid Disodium Salt

35. Phosphonic Acid, (3-methyloxiranyl)-, Disodium Salt, (2r-cis)-

36. Fosfomycin Sodium (jp17)

37. Schembl9634056

38. Chembl1256140

39. Fosfomycin Sodium [mart.]

40. Dtxsid401017220

41. Fosfomycin Sodium [who-dd]

42. Mfcd00056853

43. Phosphonic Acid, (1,2-epoxypropyl)-, Disodium Salt (1r,2s) (-)-

44. Akos015963278

45. Ccg-266439

46. Fosfomycin Sodium [ep Impurity]

47. Fosfomycin Sodium [ep Monograph]

48. 25162-71-4

49. As-11021

50. As-13713

51. F0889

52. Disodium (1r,2s)-1,2-epoxypropylphosphonate

53. D02188

54. Sodium ((2r,3s)-3-methyloxiran-2-yl)phosphonate

55. Fosfomycin Sodium, Vetranal(tm), Analytical Standard

56. Q27272022

57. (1r,2s)-1,2-epoxypropylphosphonic Acid Disodium Salt

58. Disodium (2r,3s)-3-methyloxiran-2-ylphosphonate

59. Phosphomycin Disodium Salt, Antibacterial Mura Inhibitor

60. Z1583387379

61. Phosphonic Acid,(3-methyloxiranyl)-,disodium Salt,cis-(+-)-

62. Disodium;[(2r,3s)-3-methyloxiran-2-yl]-dioxido-oxo-lambda5-phosphane

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 182.02 g/mol
Molecular Formula C3H5Na2O4P
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count4
Rotatable Bond Count0
Exact Mass181.97208420 g/mol
Monoisotopic Mass181.97208420 g/mol
Topological Polar Surface Area75.7 Ų
Heavy Atom Count10
Formal Charge0
Complexity127
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3

API Reference Price

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24-Jan-2022
06-Sep-2024
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FDF Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPolfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

Flag Poland
Digital Content Digital Content

Regulatory Info : Dossier Availability: Q2 2025

Registration Country : Poland

Fosfomycin Sodium

Brand Name :

Dosage Form : Powder for Solution for Infusion

Dosage Strength : 40MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Availability: Q2 2025

Registration Country : Poland

Polfa Tarchomin

02

EPS
Not Confirmed
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EPS
Not Confirmed

Fosfomycin Sodium

Brand Name :

Dosage Form : Powder for Injection

Dosage Strength : 1g

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

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03

EPS
Not Confirmed
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EPS
Not Confirmed

Fosfomycin Sodium

Brand Name : FOSFOL

Dosage Form : Injection

Dosage Strength : 4GM

Packaging : 1x4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Listed Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPolfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

Flag Poland
Digital Content Digital Content

Regulatory Info : Dossier Availability: Q2 2025

Registration Country : Poland

Fosfomycin Sodium

Brand Name :

Dosage Form : Powder for Solution fo...

Dosage Strength : 40MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Availability: Q2 2025

Registration Country : Poland

Polfa Tarchomin

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPolfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

Flag Poland
Digital Content Digital Content

Packaging :

Regulatory Info : Dossier Availability: Q2 2025

Fosfomycin Sodium

Dosage : Powder for Solution fo...

Dosage Strength : 40MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Poland

Polfa Tarchomin

02

EPS
Not Confirmed
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EPS
Not Confirmed

Fosfomycin Sodium

Brand Name :

Dosage Form : Powder for Injection

Dosage Strength : 1g

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

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EPS
Not Confirmed
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EPS
Not Confirmed

Fosfomycin Sodium

Dosage : Powder for Injection

Dosage Strength : 1g

Brand Name :

Approval Date :

Application Number :

Registration Country : China

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03

EPS
Not Confirmed
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EPS
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Fosfomycin Sodium

Brand Name : FOSFOL

Dosage Form : Injection

Dosage Strength : 4GM

Packaging : 1x4

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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03

EPS
Not Confirmed
arrow
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EPS
Not Confirmed

Fosfomycin Sodium

Dosage : Injection

Dosage Strength : 4GM

Brand Name : FOSFOL

Approval Date :

Application Number :

Registration Country : India

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DATA COMPILATION #PharmaFlow

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DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions
Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   

Impressions: 7820

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

#PharmaFlow by PHARMACOMPASS
24 Oct 2024

NEWS #PharmaBuzz

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Nabriva hit with 2nd FDA complete response letter for Contepo
Nabriva hit with 2nd FDA complete response letter for Contepo

23 Jun 2020

// K. Blankenship FIERCE PHARMA

https://www.fiercepharma.com/manufacturing/nabriva-hits-another-fda-setback-complete-response-letter-for-antibiotic-contepo

K. Blankenship FIERCE PHARMA
23 Jun 2020

https://www.biospace.com/article/releases/nabriva-therapeutics-receives-complete-response-letter-from-fda-on-nda-for-contepo-fosfomycin-for-injection/

BIOSPACE
21 Jun 2020

https://www.ema.europa.eu/en/news/recommendations-restrict-use-fosfomycin-antibiotics

EMA
27 Mar 2020

https://www.agsolutiongroup.com/en/interquim-ferrer/

PRESS RELEASE
02 Mar 2020

https://www.globenewswire.com/news-release/2020/01/08/1968089/0/en/Nabriva-Therapeutics-Receives-FDA-Acknowledgement-of-New-Drug-Application-Resubmission-for-Intravenous-CONTEPO-fosfomycin-for-Injection.html

GLOBE NEWSWIRE
08 Jan 2020

https://www.globenewswire.com/news-release/2020/01/08/1968089/0/en/Nabriva-Therapeutics-Receives-FDA-Acknowledgement-of-New-Drug-Application-Resubmission-for-Intravenous-CONTEPO-fosfomycin-for-Injection.html

GLOBE NEWSWIRE
07 Jan 2020

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Looking for 26016-99-9 / Fosfomycin Sodium API manufacturers, exporters & distributors?

Fosfomycin Sodium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Fosfomycin Sodium 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 Fosfomycin Sodium manufacturer or Fosfomycin Sodium supplier for your needs.

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

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

API | Excipient name

Fosfomycin Sodium

Synonyms

Fosfomycin disodium, 26016-99-9, Phosphonemycin, Fosfomycin disodium salt, Phosphomycin disodium salt, Veramina

Cas Number

26016-99-9

Unique Ingredient Identifier (UNII)

97MMO19FNO

Fosfomycin Sodium Manufacturers

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

click here to find a list of Fosfomycin Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Fosfomycin Sodium Suppliers

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

click here to find a list of Fosfomycin Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Fosfomycin Sodium USDMF

A Fosfomycin Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosfomycin Sodium active pharmaceutical ingredient (API) in detail. Different forms of Fosfomycin Sodium DMFs exist exist since differing nations have different regulations, such as Fosfomycin Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Fosfomycin Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Fosfomycin Sodium USDMF includes data on Fosfomycin Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosfomycin Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Fosfomycin Sodium suppliers with USDMF on PharmaCompass.

Fosfomycin Sodium JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Fosfomycin Sodium Drug Master File in Japan (Fosfomycin Sodium JDMF) empowers Fosfomycin Sodium API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Fosfomycin Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Fosfomycin Sodium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Fosfomycin Sodium suppliers with JDMF on PharmaCompass.

Fosfomycin Sodium NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Fosfomycin Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Fosfomycin Sodium API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Fosfomycin Sodium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Fosfomycin Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fosfomycin Sodium NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Fosfomycin Sodium suppliers with NDC on PharmaCompass.

Fosfomycin Sodium GMP

Fosfomycin Sodium 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 Fosfomycin Sodium 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 Fosfomycin Sodium GMP manufacturer or Fosfomycin Sodium GMP API supplier for your needs.

Fosfomycin Sodium CoA

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

Fosfomycin Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Fosfomycin Sodium 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.

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