Synopsis
Synopsis
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
US Medicaid
NA
Annual Reports
NA
Regulatory FDF Prices
NA
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
News #PharmaBuzz
1. Ephedrine
2. Ephedrine Erythro Isomer
3. Ephedrine Renaudin
4. Ephedrine Sulfate
5. Erythro Isomer Of Ephedrine
6. Hydrochloride, Ephedrine
7. Renaudin, Ephedrine
8. Sal Phedrine
9. Sal-phedrine
10. Salphedrine
11. Sulfate, Ephedrine
1. 50-98-6
2. (-)-ephedrine Hydrochloride
3. L-ephedrine Hydrochloride
4. 1-ephedrine Hydrochloride
5. Ephedrine Hcl
6. Ephedrine (hydrochloride)
7. Nlj6390p1z
8. Nsc-759611
9. Ephedronguent
10. (1r,2s)-2-(methylamino)-1-phenylpropan-1-ol Hydrochloride
11. Altusin
12. Dsstox_cid_25825
13. Dsstox_rid_81156
14. Dsstox_gsid_45825
15. Ephedrinium Chloride
16. L-ephedrine, Hydrochloride
17. (-)-ephedrin Hydrochloride
18. Cas-50-98-6
19. Einecs 200-074-6
20. (1r,2s)-2-(methylamino)-1-phenylpropan-1-ol;hydrochloride
21. Unii-nlj6390p1z
22. Ephedrine Hydrochloride [usan:ban:jan]
23. Ncgc00094665-01
24. Rezipres
25. (1r,2s)-(-)-ephedrine Hydrochloride
26. Ephedrini Hydrochloridum
27. N-methyl-beta-oxy-beta-phenylisopropylaminhydrochlorid [german]
28. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, Hydrochloride, (r-(r*,s*))-
29. Ec 200-074-6
30. Schembl22822
31. Ephedrine Hydrochloride (tn)
32. Ephedrine Hydrochloride Racemic
33. N-methyl-beta-oxy-beta-phenylisopropylaminhydrochlorid
34. Chembl2146102
35. Dtxsid1045825
36. Chebi:31541
37. Hy-b1195a
38. Str01942
39. Ephedrine Hydrochloride [mi]
40. Tox21_111310
41. Ephedrine Hydrochloride (jp17/usp)
42. Ephedrine Hydrochloride [jan]
43. Akos015895154
44. Tox21_111310_1
45. Ccg-229523
46. Cs-4803
47. Ephedrine Hydrochloride [mart.]
48. Ephedrine Hydrochloride [vandf]
49. Nsc 759611
50. Benzenemethanol, .alpha.-[(1s)-1-(methylamino)ethyl]-, Hydrochloride, (.alpha.r)-
51. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, Hydrochloride, (alphar)-
52. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, Hydrochloride, (theta-(theta,s))-
53. Ephedrine Hydrochloride [usp-rs]
54. Ephedrine Hydrochloride [who-dd]
55. Ephedrine Hydrochloride [who-ip]
56. Ncgc00015408-03
57. (1r,2s)-(-)-ephedrinehydrochloride
58. Ephedrine Hydrochloride [ep Impurity]
59. Ephedrine Hydrochloride [orange Book]
60. (-)-ephedrine Hydrochloride [who-ip]
61. (1r,2s)-(-)-ephedrine Hydrochloride, 99%
62. Ephedrine Hydrochloride [ep Monograph]
63. D01386
64. Ephedrine Hydrochloride [usp Monograph]
65. Ephedrini Hydrochloridum [who-ip Latin]
66. 066e127
67. Q27284939
68. (1r,2s)-ephedrine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)
69. Ephedrine Hydrochloride, United States Pharmacopeia (usp) Reference Standard
70. (r-(r*,s*))-.alpha.-(1-(methylamino)ethyl)benzenemethanol Hydrochloride [who-ip]
71. Benzenemethanol, .alpha.-(1-(methylamino)ethyl)-, Hydrochloride, (r-(r*,s*))-
72. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, Hydrochloride (1:1), (alphar)-
73. Ephedrine Hydrochloride, Drug Precursor, European Pharmacopoeia (ep) Reference Standard
| Molecular Weight | 201.69 g/mol |
|---|---|
| Molecular Formula | C10H16ClNO |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 3 |
| Exact Mass | 201.0920418 g/mol |
| Monoisotopic Mass | 201.0920418 g/mol |
| Topological Polar Surface Area | 32.3 Ų |
| Heavy Atom Count | 13 |
| Formal Charge | 0 |
| Complexity | 121 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Adrenergic Agents
Drugs that act on adrenergic receptors or affect the life cycle of adrenergic transmitters. Included here are adrenergic agonists and antagonists and agents that affect the synthesis, storage, uptake, metabolism, or release of adrenergic transmitters. (See all compounds classified as Adrenergic Agents.)
Sympathomimetics
Drugs that mimic the effects of stimulating postganglionic adrenergic sympathetic nerves. Included here are drugs that directly stimulate adrenergic receptors and drugs that act indirectly by provoking the release of adrenergic transmitters. (See all compounds classified as Sympathomimetics.)
Central Nervous System Stimulants
A loosely defined group of drugs that tend to increase behavioral alertness, agitation, or excitation. They work by a variety of mechanisms, but usually not by direct excitation of neurons. The many drugs that have such actions as side effects to their main therapeutic use are not included here. (See all compounds classified as Central Nervous System Stimulants.)
Vasoconstrictor Agents
Drugs used to cause constriction of the blood vessels. (See all compounds classified as Vasoconstrictor Agents.)
API SUPPLIERS
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Date of Issue : 2021-02-26
Valid Till : 2024-02-25
Written Confirmation Number : WC-0364
Address of the Firm :
NDC Package Code : 57218-112
Start Marketing Date : 1995-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2021-11-25
Registration Number : 20211125-41-C-398-11
Manufacturer Name : Malladi Drugs & Pharmaceuticals Limited
Manufacturer Address : Plot No. 67, Sipcot Industrial Complex, Ranipet-632 403, Ranipet District, India
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Registrant Name : GL Pharma Co., Ltd.
Registration Date : 2012-02-17
Registration Number : 20050831-41-C-46-03(2)
Manufacturer Name : Malladi Drug & Pharmaceuticals Limited
Manufacturer Address : 7B&7C, SIPCOT Industrial Complex, Ranipet-632 403, Vellore District (52, Jawaharlal Nehru Salai, Ekkattuthangal, Chennai-600 097, Tamil Nadu, India)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18271
Submission : 2005-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15753
Submission : 2001-12-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16619
Submission : 2003-06-05
Status : Inactive
Type : II
Date of Issue : 2013-07-31
Valid Till : 2016-07-02
Written Confirmation Number : WC-0221
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9278
Submission : 1991-08-09
Status : Inactive
Type : II
Registration Number : 220MF10147
Registrant's Address : 501, 5th Floor, SENTINEL, Central Avenue Road, Hiranandani Gardens, Powai, Mumbai 400 076. INDIA.
Initial Date of Registration : 2008-06-10
Latest Date of Registration :
Date of Issue : 2022-09-01
Valid Till : 2025-07-28
Written Confirmation Number : WC-0046
Address of the Firm :
NDC Package Code : 60646-101
Start Marketing Date : 1999-07-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Wonpung Pharmaceutical Co., Ltd.
Registration Date : 2020-03-25
Registration Number : 20050831-41-C-56-10(7)
Manufacturer Name : Embio Limited
Manufacturer Address : E-21, MIDC Industrial Estate, Mahad, Dist-Raigad, Maharashtra pin-402309 Raigad 402309 Maharashtra state, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4783
Submission : 1982-11-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12230
Submission : 1996-11-18
Status : Inactive
Type : II
Certificate Number : R0-CEP 2004-152 - Rev 00
Issue Date : 2005-12-15
Type : Chemical
Substance Number : 487
Status : Withdrawn by EDQM F...
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17817
Submission : 2004-11-09
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-193 - Rev 00
Issue Date : 2010-06-17
Type : Chemical
Substance Number : 487
Status : Withdrawn by Holder
Registrant Name : Sanil Pharma Co., Ltd.
Registration Date : 2012-05-25
Registration Number : 20050831-41-C-45-02(1)
Manufacturer Name : Chifeng Arker Pharmaceutical Technology Co., Ltd
Manufacturer Address : North Qinghe Road, Hongshan District, Chifeng, 024001 Inner Mongolia, China
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
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 
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
Regulatory Info : Generic
Registration Country : Turkey
Brand Name : BRONKOFLU
Dosage Form : Syrup
Dosage Strength : 6.66MG; 100MG
Packaging : 150 ml Glass Bottle
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info :
Registration Country : Sweden
Brand Name : Ephedrine Stragen
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 3 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Ephedrine Mylan
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 50 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION;INTRAVENOUS - 23.5MG/5ML (4...DOSAGE - SOLUTION;INTRAVENOUS - 23.5MG/5ML (4.7MG/ML)
USFDA APPLICATION NUMBER - 213536
DOSAGE - SOLUTION;INTRAVENOUS - 47MG/10ML (4....DOSAGE - SOLUTION;INTRAVENOUS - 47MG/10ML (4.7MG/ML)
USFDA APPLICATION NUMBER - 213536
DOSAGE - SOLUTION;INTRAVENOUS - 47MG/ML (47MG...DOSAGE - SOLUTION;INTRAVENOUS - 47MG/ML (47MG/ML)
USFDA APPLICATION NUMBER - 213536
DOSAGE - SOLUTION;INTRAVENOUS - 47MG/5ML (9.4...DOSAGE - SOLUTION;INTRAVENOUS - 47MG/5ML (9.4MG/ML)
USFDA APPLICATION NUMBER - 213536
Related Excipient Companies
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]Faran Shimi Pharmaceutical
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]Actylis
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]Bioplus Life Sciences
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
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]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]Ideal Cures Pvt Ltd
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]Microlex e.U
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]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]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]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
Disintegrants & Superdisintegrants
Direct Compression
Thickeners and Stabilizers
Granulation
Lubricants & Glidants
Solubilizers
Taste Masking
Co-Processed Excipients
Film Formers & Plasticizers
Coating Systems & Additives
Controlled & Modified Release
Chewable & Orodispersible Aids
Topical
Emulsifying Agents
Parenteral
API Stability Enhancers
Rheology Modifiers
Digital Content
DATA COMPILATION #PharmaFlow
Market Place
APIs
Reply
04 Feb 2025
Reply
08 Oct 2024
Reply
10 May 2024
Reply
30 Nov 2023
Reply
17 Aug 2023
Reply
17 Oct 2022
Reply
14 Jul 2022
Reply
21 Jun 2022
Reply
09 Feb 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
10
PharmaCompass offers a list of Ephedrine Hydrochloride 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 Ephedrine Hydrochloride manufacturer or Ephedrine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ephedrine Hydrochloride manufacturer or Ephedrine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Ephedrine Hydrochloride API Price utilized in the formulation of products. Ephedrine Hydrochloride API Price is not always fixed or binding as the Ephedrine Hydrochloride Price is obtained through a variety of data sources. The Ephedrine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A L-EPHEDRINE HCL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-EPHEDRINE HCL, including repackagers and relabelers. The FDA regulates L-EPHEDRINE HCL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-EPHEDRINE HCL 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 L-EPHEDRINE HCL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-EPHEDRINE HCL supplier is an individual or a company that provides L-EPHEDRINE HCL active pharmaceutical ingredient (API) or L-EPHEDRINE HCL finished formulations upon request. The L-EPHEDRINE HCL suppliers may include L-EPHEDRINE HCL API manufacturers, exporters, distributors and traders.
click here to find a list of L-EPHEDRINE HCL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-EPHEDRINE HCL DMF (Drug Master File) is a document detailing the whole manufacturing process of L-EPHEDRINE HCL active pharmaceutical ingredient (API) in detail. Different forms of L-EPHEDRINE HCL DMFs exist exist since differing nations have different regulations, such as L-EPHEDRINE HCL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-EPHEDRINE HCL DMF submitted to regulatory agencies in the US is known as a USDMF. L-EPHEDRINE HCL USDMF includes data on L-EPHEDRINE HCL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-EPHEDRINE HCL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-EPHEDRINE HCL 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 L-EPHEDRINE HCL Drug Master File in Japan (L-EPHEDRINE HCL JDMF) empowers L-EPHEDRINE HCL 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 L-EPHEDRINE HCL JDMF during the approval evaluation for pharmaceutical products. At the time of L-EPHEDRINE HCL 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 L-EPHEDRINE HCL 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 L-EPHEDRINE HCL Drug Master File in Korea (L-EPHEDRINE HCL KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of L-EPHEDRINE HCL. The MFDS reviews the L-EPHEDRINE HCL KDMF as part of the drug registration process and uses the information provided in the L-EPHEDRINE HCL KDMF to evaluate the safety and efficacy of the drug.
After submitting a L-EPHEDRINE HCL 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 L-EPHEDRINE HCL API can apply through the Korea Drug Master File (KDMF).
click here to find a list of L-EPHEDRINE HCL suppliers with KDMF on PharmaCompass.
A L-EPHEDRINE HCL CEP of the European Pharmacopoeia monograph is often referred to as a L-EPHEDRINE HCL Certificate of Suitability (COS). The purpose of a L-EPHEDRINE HCL CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-EPHEDRINE HCL EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-EPHEDRINE HCL to their clients by showing that a L-EPHEDRINE HCL CEP has been issued for it. The manufacturer submits a L-EPHEDRINE HCL CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-EPHEDRINE HCL CEP holder for the record. Additionally, the data presented in the L-EPHEDRINE HCL CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-EPHEDRINE HCL DMF.
A L-EPHEDRINE HCL CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-EPHEDRINE HCL 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 L-EPHEDRINE HCL suppliers with CEP (COS) on PharmaCompass.
A L-EPHEDRINE HCL written confirmation (L-EPHEDRINE HCL WC) is an official document issued by a regulatory agency to a L-EPHEDRINE HCL manufacturer, verifying that the manufacturing facility of a L-EPHEDRINE HCL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting L-EPHEDRINE HCL APIs or L-EPHEDRINE HCL finished pharmaceutical products to another nation, regulatory agencies frequently require a L-EPHEDRINE HCL WC (written confirmation) as part of the regulatory process.
click here to find a list of L-EPHEDRINE HCL 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 L-EPHEDRINE HCL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for L-EPHEDRINE HCL 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 L-EPHEDRINE HCL 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 L-EPHEDRINE HCL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a L-EPHEDRINE HCL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of L-EPHEDRINE HCL suppliers with NDC on PharmaCompass.
L-EPHEDRINE HCL 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 L-EPHEDRINE HCL 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 L-EPHEDRINE HCL GMP manufacturer or L-EPHEDRINE HCL GMP API supplier for your needs.
A L-EPHEDRINE HCL CoA (Certificate of Analysis) is a formal document that attests to L-EPHEDRINE HCL's compliance with L-EPHEDRINE HCL specifications and serves as a tool for batch-level quality control.
L-EPHEDRINE HCL CoA mostly includes findings from lab analyses of a specific batch. For each L-EPHEDRINE HCL 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.
L-EPHEDRINE HCL may be tested according to a variety of international standards, such as European Pharmacopoeia (L-EPHEDRINE HCL EP), L-EPHEDRINE HCL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-EPHEDRINE HCL USP).
Comment (5)
