Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. 2 Propylpentanoic Acid
2. 2-propylpentanoic Acid
3. Calcium Valproate
4. Convulsofin
5. Depakene
6. Depakine
7. Depakote
8. Dipropyl Acetate
9. Divalproex
10. Ergenyl
11. Magnesium Valproate
12. Propylisopropylacetic Acid
13. Semisodium Valproate
14. Sodium Valproate
15. Valproate
16. Valproate Calcium
17. Valproate Sodium
18. Valproic Acid
19. Valproic Acid, Sodium Salt (2:1)
20. Vupral
1. 76584-70-8
2. Valproate Semisodium
3. Epival
4. Depakote
5. Sodium Divalproate
6. Semisodium Valproate
7. Sprinkle
8. Abbott 50711
9. Divalproex
10. Valdisoval
11. Valproato Semisodico
12. Delepsine
13. Valcote
14. Valparin
15. Epilex
16. Valproate Semisodique
17. Sodium Hydrogen Divalproate
18. Valproatum Seminatricum
19. Sodium Hydrogen Bis(2-propylpentanoate)
20. Pentanoic Acid, 2-propyl-, Sodium Salt (2:1)
21. Abbott-50711
22. Sodium Hydrogen Bis(2-propylvalerate)
23. Divalproex Sodium [usan:usp]
24. Divalproex (sodium)
25. Sodium;2-propylpentanoate;2-propylpentanoic Acid
26. Valproate Semisodium (inn)
27. Depakote Er
28. Chebi:4667
29. Divalproate
30. Valproic Acid (semisodium Salt)
31. Depakote Cp
32. Valproate Semisodium [inn]
33. Valproate Semisodique [french]
34. Valproato Semisodico [spanish]
35. Valproatum Seminatricum [latin]
36. Valproic Acid Semisodium Salt
37. Depakote (tn)
38. Natrium Hydrogen Bis(2-propylvalerat)
39. Valproic Acid Semisodium Salt (2:1)
40. 644vl95ao6
41. Valproic Acid Sodium Salt (2:1)
42. Divalproex Sodium (usp)
43. Unii-644vl95ao6
44. Sodium Divalproex
45. Sodium Hydrogen Bis(2-propylvalerate), Oligomer
46. Sodium; 2-propylpentanoate; 2-propylpentanoic Acid
47. Schembl40996
48. Chembl2105613
49. Sodium;hydron;2-propylpentanoate
50. Dtxsid70227388
51. Hms3651c17
52. Hms3884o06
53. Bcp12800
54. S1703
55. Sodiumhydrogenbis(2-propylpentanoate)
56. Akos015895200
57. Ccg-267581
58. As-17254
59. Db-056089
60. Ft-0625375
61. Sw219169-1
62. C76453
63. D00304
64. Ab01568255_01
65. A838751
66. Sodium 2-propylpentanoate--2-propylpentanoic Acid (1:1)
| Molecular Weight | 310.40 g/mol |
|---|---|
| Molecular Formula | C16H31NaO4 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 10 |
| Exact Mass | 310.21200375 g/mol |
| Monoisotopic Mass | 310.21200375 g/mol |
| Topological Polar Surface Area | 77.4 Ų |
| Heavy Atom Count | 21 |
| Formal Charge | 0 |
| Complexity | 192 |
| 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 | 3 |
| 1 of 6 | |
|---|---|
| Drug Name | Depakote |
| Drug Label | Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is d... |
| Active Ingredient | Divalproex sodium |
| Dosage Form | Capsule, delayed rel pellets; Tablet, delayed release |
| Route | Oral |
| Strength | eq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid |
| Market Status | Prescription |
| Company | Abbvie |
| 2 of 6 | |
|---|---|
| Drug Name | Depakote er |
| Drug Label | Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is d... |
| Active Ingredient | Divalproex sodium |
| Dosage Form | Tablet, extended release |
| Route | oral; Oral |
| Strength | 250mg; eq 500mg valproic acid; eq 250mg valproic acid; 500mg |
| Market Status | Prescription |
| Company | Abbott; Abbvie |
| 3 of 6 | |
|---|---|
| Drug Name | Divalproex sodium |
| Drug Label | Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:Di... |
| Active Ingredient | Divalproex sodium |
| Dosage Form | Tablet, extended release; Capsule, delayed rel pellets; Tablet, delayed release |
| Route | Oral |
| Strength | eq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid |
| Market Status | Prescription |
| Company | Anchen Pharms; Wockhardt; Upsher Smith; Nu Pharm; Actavis Labs Fl; Teva; Vintage; Aurobindo Pharma; Sun Pharm Inds; Reddys; Lupin; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Orchid Hlthcare; Mylan; Unichem Labs; Impax Labs |
| 4 of 6 | |
|---|---|
| Drug Name | Depakote |
| Drug Label | Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is d... |
| Active Ingredient | Divalproex sodium |
| Dosage Form | Capsule, delayed rel pellets; Tablet, delayed release |
| Route | Oral |
| Strength | eq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid |
| Market Status | Prescription |
| Company | Abbvie |
| 5 of 6 | |
|---|---|
| Drug Name | Depakote er |
| Drug Label | Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is d... |
| Active Ingredient | Divalproex sodium |
| Dosage Form | Tablet, extended release |
| Route | oral; Oral |
| Strength | 250mg; eq 500mg valproic acid; eq 250mg valproic acid; 500mg |
| Market Status | Prescription |
| Company | Abbott; Abbvie |
| 6 of 6 | |
|---|---|
| Drug Name | Divalproex sodium |
| Drug Label | Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:Di... |
| Active Ingredient | Divalproex sodium |
| Dosage Form | Tablet, extended release; Capsule, delayed rel pellets; Tablet, delayed release |
| Route | Oral |
| Strength | eq 125mg valproic acid; eq 500mg valproic acid; eq 250mg valproic acid |
| Market Status | Prescription |
| Company | Anchen Pharms; Wockhardt; Upsher Smith; Nu Pharm; Actavis Labs Fl; Teva; Vintage; Aurobindo Pharma; Sun Pharm Inds; Reddys; Lupin; Zydus Pharms Usa; Dr Reddys Labs; Sandoz; Orchid Hlthcare; Mylan; Unichem Labs; Impax Labs |
Anticonvulsants
Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)
Antimanic Agents
Agents that are used to treat bipolar disorders or mania associated with other affective disorders. (See all compounds classified as Antimanic Agents.)
Enzyme Inhibitors
Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)
GABA Agents
Substances used for their pharmacological actions on GABAergic systems. GABAergic agents include agonists, antagonists, degradation or uptake inhibitors, depleters, precursors, and modulators of receptor function. (See all compounds classified as GABA Agents.)
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
About the Company : We’re a company that takes on the toughest health challenges. But we do more than treat diseases—we aim to make a remarkable impact on people’s lives. We are AbbVie, a highly...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
About the Company : Chynops Pharma, a company certified with ISO 9001:2015, is situated in Ahmedabad, India. We specialize in exporting, supplying, and trading a wide range of products, including APIs...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...
Venkar Chemicals – WHO-GMP & ISO Certified API Experts Delivering Global Standards.
About the Company : Venkar Chemicals Pvt. Ltd. is a WHO-GMP, ISO 9001:2008, and ISO 14000:2004 certified company and a leading manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediate...
About the Company : Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE;ORAL - 250MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18081
DOSAGE - SYRUP;ORAL - 250MG/5ML **Federal Reg...DOSAGE - SYRUP;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18082
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 12...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 125MG VALPROIC ACID
USFDA APPLICATION NUMBER - 18723
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 25...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID
USFDA APPLICATION NUMBER - 18723
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 50...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 500MG VALPROIC ACID
USFDA APPLICATION NUMBER - 18723
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 125MG VALPROIC ACID
USFDA APPLICATION NUMBER - 19680
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 250MG VALPROIC ACID
USFDA APPLICATION NUMBER - 21168
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 500MG VALPROIC ACID
USFDA APPLICATION NUMBER - 21168
Related Excipient Companies
Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Avesta Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Doshion Polyscience
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Huzhou Sunflower Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
Coating Systems & Additives
Disintegrants & Superdisintegrants
Controlled & Modified Release
Direct Compression
Solubilizers
Thickeners and Stabilizers
Granulation
Taste Masking
Film Formers & Plasticizers
Topical
Lubricants & Glidants
Parenteral
Chewable & Orodispersible Aids
Co-Processed Excipients
Rheology Modifiers
Emulsifying Agents
Empty Capsules
API Stability Enhancers
Surfactant & Foaming Agents
Coloring Agents
Vegetarian Capsules
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
77
PharmaCompass offers a list of Divalproex 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 Divalproex Sodium manufacturer or Divalproex Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Divalproex Sodium manufacturer or Divalproex Sodium supplier.
PharmaCompass also assists you with knowing the Divalproex Sodium API Price utilized in the formulation of products. Divalproex Sodium API Price is not always fixed or binding as the Divalproex Sodium Price is obtained through a variety of data sources. The Divalproex Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Valproato semisodico [Spanish] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valproato semisodico [Spanish], including repackagers and relabelers. The FDA regulates Valproato semisodico [Spanish] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valproato semisodico [Spanish] 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 Valproato semisodico [Spanish] manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valproato semisodico [Spanish] supplier is an individual or a company that provides Valproato semisodico [Spanish] active pharmaceutical ingredient (API) or Valproato semisodico [Spanish] finished formulations upon request. The Valproato semisodico [Spanish] suppliers may include Valproato semisodico [Spanish] API manufacturers, exporters, distributors and traders.
click here to find a list of Valproato semisodico [Spanish] suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valproato semisodico [Spanish] DMF (Drug Master File) is a document detailing the whole manufacturing process of Valproato semisodico [Spanish] active pharmaceutical ingredient (API) in detail. Different forms of Valproato semisodico [Spanish] DMFs exist exist since differing nations have different regulations, such as Valproato semisodico [Spanish] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valproato semisodico [Spanish] DMF submitted to regulatory agencies in the US is known as a USDMF. Valproato semisodico [Spanish] USDMF includes data on Valproato semisodico [Spanish]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valproato semisodico [Spanish] USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valproato semisodico [Spanish] suppliers with USDMF on PharmaCompass.
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 Valproato semisodico [Spanish] Drug Master File in Japan (Valproato semisodico [Spanish] JDMF) empowers Valproato semisodico [Spanish] 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 Valproato semisodico [Spanish] JDMF during the approval evaluation for pharmaceutical products. At the time of Valproato semisodico [Spanish] 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 Valproato semisodico [Spanish] suppliers with JDMF 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 Valproato semisodico [Spanish] Drug Master File in Korea (Valproato semisodico [Spanish] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Valproato semisodico [Spanish]. The MFDS reviews the Valproato semisodico [Spanish] KDMF as part of the drug registration process and uses the information provided in the Valproato semisodico [Spanish] KDMF to evaluate the safety and efficacy of the drug.
After submitting a Valproato semisodico [Spanish] 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 Valproato semisodico [Spanish] API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Valproato semisodico [Spanish] suppliers with KDMF on PharmaCompass.
A Valproato semisodico [Spanish] CEP of the European Pharmacopoeia monograph is often referred to as a Valproato semisodico [Spanish] Certificate of Suitability (COS). The purpose of a Valproato semisodico [Spanish] CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Valproato semisodico [Spanish] EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Valproato semisodico [Spanish] to their clients by showing that a Valproato semisodico [Spanish] CEP has been issued for it. The manufacturer submits a Valproato semisodico [Spanish] CEP (COS) as part of the market authorization procedure, and it takes on the role of a Valproato semisodico [Spanish] CEP holder for the record. Additionally, the data presented in the Valproato semisodico [Spanish] CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Valproato semisodico [Spanish] DMF.
A Valproato semisodico [Spanish] CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Valproato semisodico [Spanish] CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Valproato semisodico [Spanish] suppliers with CEP (COS) on PharmaCompass.
A Valproato semisodico [Spanish] written confirmation (Valproato semisodico [Spanish] WC) is an official document issued by a regulatory agency to a Valproato semisodico [Spanish] manufacturer, verifying that the manufacturing facility of a Valproato semisodico [Spanish] active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Valproato semisodico [Spanish] APIs or Valproato semisodico [Spanish] finished pharmaceutical products to another nation, regulatory agencies frequently require a Valproato semisodico [Spanish] WC (written confirmation) as part of the regulatory process.
click here to find a list of Valproato semisodico [Spanish] 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 Valproato semisodico [Spanish] as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Valproato semisodico [Spanish] 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 Valproato semisodico [Spanish] 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 Valproato semisodico [Spanish] and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Valproato semisodico [Spanish] NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Valproato semisodico [Spanish] suppliers with NDC on PharmaCompass.
Valproato semisodico [Spanish] 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 Valproato semisodico [Spanish] 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 Valproato semisodico [Spanish] GMP manufacturer or Valproato semisodico [Spanish] GMP API supplier for your needs.
A Valproato semisodico [Spanish] CoA (Certificate of Analysis) is a formal document that attests to Valproato semisodico [Spanish]'s compliance with Valproato semisodico [Spanish] specifications and serves as a tool for batch-level quality control.
Valproato semisodico [Spanish] CoA mostly includes findings from lab analyses of a specific batch. For each Valproato semisodico [Spanish] 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.
Valproato semisodico [Spanish] may be tested according to a variety of international standards, such as European Pharmacopoeia (Valproato semisodico [Spanish] EP), Valproato semisodico [Spanish] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Valproato semisodico [Spanish] USP).
