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1. Arn-509
2. Erleada
1. Arn-509
2. 956104-40-8
3. Erleada
4. Jnj-56021927
5. Arn 509
6. Apalutamide [inn]
7. Arn509
8. Apalutamide (arn-509)
9. 4-(7-(6-cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluoro-n-methylbenzamide
10. 4t36h88ua7
11. 956104-40-8 (free Base)
12. 4-[7-[6-cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl]-2-fluoro-n-methylbenzamide
13. 4-{7-[6-cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl}-2-fluoro-n-methylbenzamide
14. 4-(7-(6-cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro(3.4)octan-5-yl)-2-fluoro-n-methylbenzamide
15. Unii-4t36h88ua7
16. Ar509
17. Apalutamidearn509
18. Erleada (tn)
19. Jnj 56021927
20. Apalutamide (jan/inn)
21. Apalutamide [mi]
22. Apalutamide [jan]
23. Apalutamide [who-dd]
24. Mls006011109
25. Schembl909297
26. Gtpl9043
27. Chembl3183409
28. Apalutamide [orange Book]
29. Dtxsid40241899
30. Ex-a089
31. Hms3656n12
32. Amy24182
33. Bcp05829
34. Ar509/ar-509
35. Bdbm50094975
36. Mfcd22380626
37. Nsc771649
38. Nsc794776
39. S2840
40. Zinc43174901
41. Akos025401932
42. Ccg-264760
43. Cs-0885
44. Db11901
45. Nsc-771649
46. Nsc-794776
47. Pb27306
48. Ncgc00346725-01
49. Ncgc00346725-02
50. Ncgc00346725-06
51. Ac-27403
52. As-35181
53. Hy-16060
54. Smr004702891
55. Sw220300-1
56. 24872560, Erleada, C21h15f4n5o2s
57. D11040
58. J-519596
59. Q21098975
60. Benzamide, 4-(7-(6-cyano-5-(trifluoromethyl)-3-pyridinyl)-8-oxo-6-thioxo-5,7-diazaspiro(3.4)oct-5-yl)-2-fluoro-n-methyl-
Molecular Weight | 477.4 g/mol |
---|---|
Molecular Formula | C21H15F4N5O2S |
XLogP3 | 3 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 3 |
Exact Mass | 477.08825856 g/mol |
Monoisotopic Mass | 477.08825856 g/mol |
Topological Polar Surface Area | 121 Ų |
Heavy Atom Count | 33 |
Formal Charge | 0 |
Complexity | 886 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Indicated for the treatment of patients with non-metastatic, castration-resistant prostate cancer (NM-CRPC).
FDA Label
Erleada is indicated:
in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
In an open-label, uncontrolled, multi-center, single-arm dedicated QT study in 45 patients with CRPC, an exposure-QT analysis suggested a concentration-dependent increase in QTcF for apalutamide and its active metabolite. Apalutamide demonstrated an antitumor activity in the mouse xenograft models of prostate cancer, where it decreased tumor cell proliferation and reduced tumor volume.
L02BB05
L - Antineoplastic and immunomodulating agents
L02 - Endocrine therapy
L02B - Hormone antagonists and related agents
L02BB - Anti-androgens
L02BB05 - Apalutamide
Absorption
Mean absolute oral bioavailability was approximately 100%. Median time to achieve peak plasma concentration (tmax) was 2 hours (range: 1 to 5 hours). Median tmax may be increased with a high-fat meal. Administration of oral apalutamide at recommended dosages resulted in a steady state within 4 weeks with a maximum peak concentration (Cmax) and AUC of 6.0 mcg/mL and 100 mcgh/mL, respectively. Cmax and AUC of apalutamide is expected to increase in a dose-proportional manner. The mean mean peak-to-trough ratio was 1.63 indicating low daily fluctuations in the plasma concentrations of the drug. The major active metabolite N-desmethyl apalutamide Cmax was 5.9 mcg/mL (1.0) and AUC was 124 mcgh/mL (23) at steady-state after the recommended dosage.
Route of Elimination
Apalutamide and its main active metabolite are subject to both renal and focal elimination. Up to 70 days following a single oral administration of radiolabeled apalutamide, 65% of the dose was recovered in urine (1.2% of dose as unchanged apalutamide and 2.7% as N-desmethyl apalutamide) and 24% was recovered in feces (1.5% of dose as unchanged apalutamide and 2% as N-desmethyl apalutamide).
Volume of Distribution
The mean apparent volume of distribution at steady-state of apalutamide was approximately 276 L.
Clearance
The CL/F of apalutamide was 1.3 L/h after single dosing and increased to 2.0 L/h at steady-state after once-daily dosing. An increase in apparent clearance (CL/F) was observed with repeat dosing, likely due to induction of apalutamides own metabolism. The auto-induction effect likely reached its maximum at the recommended dosage because exposure of apalutamide across the dose range of 30 to 480 mg is dose-proportional.
Apalutamide primarily undergoes CYP2C8 and CYP3A4-mediated metabolism to its pharmacologically active metabolite, N-desmethyl apalutamide. The contribution of CYP2C8 and CYP3A4 in the total metabolism of apalutamide is approximately 58% and and 13% following single dose but changes to 40% and 37%, respectively at steady-state. The auto-induction of CYP3A4-mediated metabolism by apalutamide may explain the increase in CYP3A4 enzymatic activity at steady-state. Based on systemic exposure, relative potency, and pharmacokinetic properties, N-desmethyl apalutamide likely contributed to the clinical activity of apalutamide.
The mean effective half-life for apalutamide in patients with NM-CRPC was approximately 3 days at steady-state.
Persistent androgen receptor (AR) signaling is a common feature of castration-resistant prostate cancer (CRPC), attributed to AR gene-amplification, AR gene mutation, increased AR expression or increased androgen biosynthesis in prostate tumors. Apalutamide is an antagonist of AR that to the binding-site in the ligand-binding domain of the receptor with the IC50 of 16 nM. Upon binding, apalutamide disrupts AR signalling, inhibits DNA binding, and impedes AR-mediated gene transcription. Apalutamide impairs the translocation of AR from the cytoplasm to the nucleus thus reduces the concentrations of AR available to interact with the androgen response-elements (AREs). Upon treatment with apalutamide, AR was not recruited to the DNA promoter-regions. Its main metabolite, N-desmethyl apalutamide, is a less potent inhibitor of AR, and exhibited one-third the activity of apalutamide in an in vitro transcriptional reporter assay.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Start Marketing Date : 2020-03-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Details:
ENV105 (carotuximab) is a endoglin inhibitor which is being evaluated in phase 2 clinical trials in combination with apalutamide for the treatment of castrate-resistant prostate cancer.
Lead Product(s): Carotuximab,Apalutamide
Therapeutic Area: Oncology Brand Name: ENV105
Study Phase: Phase IIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 31, 2025
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Partner/Sponsor/Collaborator : Inapplicable
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Deal Type : Inapplicable
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Details : ENV105 (carotuximab) is a endoglin inhibitor which is being evaluated in phase 2 clinical trials in combination with apalutamide for the treatment of castrate-resistant prostate cancer.
Product Name : ENV105
Product Type : Antibody
Upfront Cash : Inapplicable
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Pryor (apalutamide) is an androgen receptor inhibitor which is indicated for the treatment of patients with prostate cancer.
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Product Name : Pryor
Product Type : HPAPI
Upfront Cash : Inapplicable
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Details:
ENV105 (carotuximab) is a endoglin inhibitor which is being evaluated in phase 2 clinical trials in combination with apalutamide for the treatment of castrate-resistant prostate cancer.
Lead Product(s): Carotuximab,Apalutamide
Therapeutic Area: Oncology Brand Name: ENV105
Study Phase: Phase IIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 11, 2025
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Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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Details : ENV105 (carotuximab) is a endoglin inhibitor which is being evaluated in phase 2 clinical trials in combination with apalutamide for the treatment of castrate-resistant prostate cancer.
Product Name : ENV105
Product Type : Antibody
Upfront Cash : Inapplicable
February 11, 2025
Details:
The collaboration aims to advance the precision of therapy monitoring for Kairos clinical trials, and to advance cancer treatment by identifying patients who will benefit most from ENV105.
Lead Product(s): Carotuximab,Apalutamide
Therapeutic Area: Oncology Brand Name: ENV105
Study Phase: Phase IIProduct Type: Antibody
Sponsor: PreCheck Health Services
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 24, 2024
Lead Product(s) : Carotuximab,Apalutamide
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : PreCheck Health Services
Deal Size : Undisclosed
Deal Type : Collaboration
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Details : The collaboration aims to advance the precision of therapy monitoring for Kairos clinical trials, and to advance cancer treatment by identifying patients who will benefit most from ENV105.
Product Name : ENV105
Product Type : Antibody
Upfront Cash : Undisclosed
September 24, 2024
Details:
The net proceeds from the offering to fund the company's lead product candidate, ENV105 (carotuximab), which is being evaluated in a mid-stage trial studies for the treatment of prostate cancer.
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Therapeutic Area: Oncology Brand Name: ENV105
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Sponsor: Boustead Securities
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Deal Type: Public Offering September 17, 2024
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Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Boustead Securities
Deal Size : $6.2 million
Deal Type : Public Offering
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Details : The net proceeds from the offering to fund the company's lead product candidate, ENV105 (carotuximab), which is being evaluated in a mid-stage trial studies for the treatment of prostate cancer.
Product Name : ENV105
Product Type : Antibody
Upfront Cash : Undisclosed
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Details:
The net proceeds from the offering to fund the company's lead product candidate, ENV105 (carotuximab), which is being evaluated in a mid-stage trial studies for the treatment of prostate cancer.
Lead Product(s): Carotuximab,Apalutamide
Therapeutic Area: Oncology Brand Name: ENV105
Study Phase: Phase IIProduct Type: Antibody
Sponsor: Boustead Securities
Deal Size: $6.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 16, 2024
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Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Boustead Securities
Deal Size : $6.2 million
Deal Type : Public Offering
Kairos Pharma Prices $6.2 Million Initial Public Offering
Details : The net proceeds from the offering to fund the company's lead product candidate, ENV105 (carotuximab), which is being evaluated in a mid-stage trial studies for the treatment of prostate cancer.
Product Name : ENV105
Product Type : Antibody
Upfront Cash : Undisclosed
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Details:
Erleada (apalutamide) is an androgen receptor inhibitor which is being investigated for patients with high-risk locally advanced prostate cancer in combination with androgen deprivation therapy.
Lead Product(s): Apalutamide,Undisclosed
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Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 05, 2024
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Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
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Deal Type : Inapplicable
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Details : Erleada (apalutamide) is an androgen receptor inhibitor which is being investigated for patients with high-risk locally advanced prostate cancer in combination with androgen deprivation therapy.
Product Name : Erleada
Product Type : HPAPI
Upfront Cash : Inapplicable
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Details:
ENV105 (carotuximab) is a endoglin inhibitor which is being evaluated in phase 2 clinical trials in combination with apalutamide for the treatment of castrate-resistant prostate cancer.
Lead Product(s): Carotuximab,Apalutamide
Therapeutic Area: Oncology Brand Name: ENV105
Study Phase: Phase IIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 30, 2024
Lead Product(s) : Carotuximab,Apalutamide
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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Details : ENV105 (carotuximab) is a endoglin inhibitor which is being evaluated in phase 2 clinical trials in combination with apalutamide for the treatment of castrate-resistant prostate cancer.
Product Name : ENV105
Product Type : Antibody
Upfront Cash : Inapplicable
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Details:
Erleada® (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
Lead Product(s): Apalutamide
Therapeutic Area: Oncology Brand Name: Erleada
Study Phase: Approved FDFProduct Type: HPAPI
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 04, 2023
Lead Product(s) : Apalutamide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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Details : Erleada® (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mC...
Product Name : Erleada
Product Type : HPAPI
Upfront Cash : Inapplicable
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Details:
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Therapeutic Area : Oncology
Highest Development Status : Approved FDF
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Upfront Cash : Inapplicable
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End Use API : Apalutamide
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CAS Number : 915087-26-2
End Use API : Apalutamide
About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...
5-amino-3-(trifluoromethyl)picolinonitrile
CAS Number : 573762-62-6
End Use API : Apalutamide
About The Company : Prajna is an innovation driven pharmaceutical company. We dedicated to Research, Process development and Manufacturing APIs and Advanced Intermediates for Activ...
Regulatory Info :
Registration Country : Switzerland
Brand Name : Erleada
Dosage Form : Filmtabl
Dosage Strength : 60mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Erleada
Dosage Form : Filmtabl
Dosage Strength : 240mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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PharmaCompass offers a list of Apalutamide 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 Apalutamide manufacturer or Apalutamide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Apalutamide manufacturer or Apalutamide supplier.
PharmaCompass also assists you with knowing the Apalutamide API Price utilized in the formulation of products. Apalutamide API Price is not always fixed or binding as the Apalutamide Price is obtained through a variety of data sources. The Apalutamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Apalutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apalutamide, including repackagers and relabelers. The FDA regulates Apalutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apalutamide 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 Apalutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Apalutamide supplier is an individual or a company that provides Apalutamide active pharmaceutical ingredient (API) or Apalutamide finished formulations upon request. The Apalutamide suppliers may include Apalutamide API manufacturers, exporters, distributors and traders.
click here to find a list of Apalutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Apalutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Apalutamide active pharmaceutical ingredient (API) in detail. Different forms of Apalutamide DMFs exist exist since differing nations have different regulations, such as Apalutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apalutamide DMF submitted to regulatory agencies in the US is known as a USDMF. Apalutamide USDMF includes data on Apalutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apalutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Apalutamide suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Apalutamide Drug Master File in Korea (Apalutamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Apalutamide. The MFDS reviews the Apalutamide KDMF as part of the drug registration process and uses the information provided in the Apalutamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Apalutamide KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Apalutamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Apalutamide suppliers with KDMF on PharmaCompass.
A Apalutamide written confirmation (Apalutamide WC) is an official document issued by a regulatory agency to a Apalutamide manufacturer, verifying that the manufacturing facility of a Apalutamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Apalutamide APIs or Apalutamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Apalutamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Apalutamide suppliers with Written Confirmation (WC) on PharmaCompass.
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 Apalutamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Apalutamide API and other APIs are published in this directory by the FDA.
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 Apalutamide 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.
The NDC directory also contains data on finished compounded human drug products that contain Apalutamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Apalutamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Apalutamide suppliers with NDC on PharmaCompass.
Apalutamide 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 Apalutamide 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 Apalutamide GMP manufacturer or Apalutamide GMP API supplier for your needs.
A Apalutamide CoA (Certificate of Analysis) is a formal document that attests to Apalutamide's compliance with Apalutamide specifications and serves as a tool for batch-level quality control.
Apalutamide CoA mostly includes findings from lab analyses of a specific batch. For each Apalutamide 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.
Apalutamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Apalutamide EP), Apalutamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Apalutamide USP).