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1. Epilincomycin
2. Hemihydrate Lincomycin Monohydrochloride
3. Lincocin
4. Lincolnensin
5. Lincomycin
6. Lincomycin A
7. Lincomycin Monohydrochloride
8. Lincomycin Monohydrochloride, (2s-cis)-isomer
9. Lincomycin Monohydrochloride, (l-threo)-isomer
10. Lincomycin Monohydrochloride, Hemihydrate
11. Lincomycin, (2s-cis)-isomer
12. Lincomycin, (l-threo)-isomer
1. 859-18-7
2. Lincomycin Hcl
3. Frademicina
4. Lincomycin (hydrochloride)
5. Mycivin
6. Lincomycin Hydrochloride Anhydrous
7. Nsc 70731
8. Lincocin
9. Gcw8y9936l
10. Lincomix 20
11. Pura Ject 100
12. Ncgc00159326-02
13. Lincolnensin, Hydrochloride
14. Dsstox_cid_27780
15. Dsstox_rid_82556
16. Dsstox_gsid_47803
17. (2s,4r)-n-((1r,2r)-2-hydroxy-1-((2r,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(methylthio)tetrahydro-2h-pyran-2-yl)propyl)-1-methyl-4-propylpyrrolidine-2-carboxamide Hydrochloride
18. Lincolnensin Hydrochloride
19. Antibiotic 124a, Hydrochloride
20. Lincogap
21. U 10149a
22. Lincocin Hydrochloride
23. Unii-gcw8y9936l
24. Mfcd00083647
25. Einecs 212-726-7
26. Cas-859-18-7
27. Lincomycin Hcl (lincocin)
28. Ec 212-726-7
29. Schembl192964
30. Chembl1201097
31. Dtxsid7047803
32. Hy-b0417a
33. Lincocin Hydrochloride Monohydrate
34. Tox21_111575
35. Akos024375415
36. Tox21_111575_1
37. Ccg-220302
38. Anhydrous Lincomycin Hydrochloride
39. Lincomycin Hydrochloride [who-dd]
40. Ncgc00159326-03
41. As-13720
42. Lincomycin Hydrochloride, >=90% (tlc)
43. Lincomycin Hydrochloride, >=95.0% (tlc)
44. L0166
45. Lincomycin Hydrochloride Anhdrous [mi]
46. Lincomycin Hydrochloride For System Suitability
47. 859l187
48. A841491
49. Anhydrous Lincomycin Hydrochloride [mart.]
50. Q27279041
51. Lincomycin Hydrochloride, Bioreagent, Suitable For Cell Culture
52. Lincomycin Hydrochloride, British Pharmacopoeia (bp) Reference Standard
53. (2s,4r)-n-[(1r,2r)-2-hydroxy-1-[(2r,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(methylsulfanyl)oxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboximidic Acid Hydrochloride
54. (2s-trans)-methyl 6,8-dideoxy-6-(((1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-d-erythro-.alpha.-d-galacto-octopyranoside Hydrochloride
55. D-erythro-.alpha.-d-galacto-octopyranoside, Methyl 6,8-dideoxy-6-(((1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-, Monohydrochloride, (2s-trans)-
56. D-erythro-.alpha.-d-galacto-octopyranoside, Methyl 6,8-dideoxy-6-[[[(2s,4r)-1-methyl-4-propyl-2-pyrrolidinyl]carbonyl]amino]-1-thio-, Hydrochloride (1:1)
57. D-erythro-alpha-d-galacto-octopyranoside, Methyl 6,8-dideoxy-6-((((2s,4r)-1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-, Monohydrochloride
58. D-erythro-alpha-d-galacto-octopyranoside, Methyl 6,8-dideoxy-6-(((1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-, Monohydrochloride, (2s-trans)-
59. D-erythro-d-galacto-octopyranoside, Methyl 6,8-dideoxy-6-(1-methyl-4-propyl-l-2-pyrrolidinecarboxamido)-1-thio-, Monohydrochloride, Trans-alpha-
60. Hydron; N-[2-hydroxy-1-(3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl)propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide; Chloride;(2s,4r)-n-{(1s)-2-hydroxy-1-[(2s,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(methylthio)-tetrahydro-2h-2-pyranyl]propyl}-1-methyl-4-propylpyrrolidine-2-carboxamide Hydrochloride
61. Methyl (2s-trans)-6,8-dideoxy-6-(((1-methyl-4-propylpyrrolidin-2-yl)carbonyl)amino)-1-thio-d-erythro-alpha-d-galacto-octopyranoside Monohydrochloride
62. Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-l-2-pyrrolidinecarboxamido)-1-thio-d-erythro-.alpha.-d-galacto-octopyranoside Monohydrochloride
| Molecular Weight | 443.0 g/mol |
|---|---|
| Molecular Formula | C18H35ClN2O6S |
| Hydrogen Bond Donor Count | 6 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 7 |
| Exact Mass | 442.1904357 g/mol |
| Monoisotopic Mass | 442.1904357 g/mol |
| Topological Polar Surface Area | 148 Ų |
| Heavy Atom Count | 28 |
| Formal Charge | 0 |
| Complexity | 499 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 9 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Lincocin |
| PubMed Health | Lincomycin (Oral route, Injection route) |
| Drug Classes | Antibiotic, Lincosamide |
| Drug Label | LINCOCIN Sterile Solution contains lincomycin hydrochloride which is the monohydrated salt of lincomycin, a substance produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical nam... |
| Active Ingredient | Lincomycin hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 300mg base/ml |
| Market Status | Prescription |
| Company | Pharmacia And Upjohn |
| 2 of 2 | |
|---|---|
| Drug Name | Lincocin |
| PubMed Health | Lincomycin (Oral route, Injection route) |
| Drug Classes | Antibiotic, Lincosamide |
| Drug Label | LINCOCIN Sterile Solution contains lincomycin hydrochloride which is the monohydrated salt of lincomycin, a substance produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical nam... |
| Active Ingredient | Lincomycin hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 300mg base/ml |
| Market Status | Prescription |
| Company | Pharmacia And Upjohn |
Protein Synthesis Inhibitors
Compounds which inhibit the synthesis of proteins. They are usually ANTI-BACTERIAL AGENTS or toxins. Mechanism of the action of inhibition includes the interruption of peptide-chain elongation, the blocking the A site of ribosomes, the misreading of the genetic code or the prevention of the attachment of oligosaccharide side chains to glycoproteins. (See all compounds classified as Protein Synthesis Inhibitors.)
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
API SUPPLIERS
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14752
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7002
Submission : 1987-06-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13753
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32322
Submission : 2017-11-23
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-06
Pay. Date : 2013-09-24
DMF Number : 26610
Submission : 2012-11-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17142
Submission : 2004-01-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31462
Submission : 2017-03-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13292
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13757
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-14
Pay. Date : 2018-07-19
DMF Number : 19056
Submission : 2005-12-08
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Lincomycin Hydrochloride, Process III, Code C201...
Certificate Number : CEP 2019-136 - Rev 03
Status : Valid
Issue Date : 2024-11-19
Type : Chemical
Substance Number : 583
Certificate Number : CEP 2018-038 - Rev 02
Status : Valid
Issue Date : 2023-11-29
Type : Chemical
Substance Number : 583
Certificate Number : R1-CEP 2008-225 - Rev 02
Status : Valid
Issue Date : 2021-11-29
Type : Chemical
Substance Number : 583
Certificate Number : R1-CEP 2007-135 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2014-02-10
Type : Chemical
Substance Number : 583
Certificate Number : R0-CEP 2018-090 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2021-12-09
Type : Chemical
Substance Number : 583
Certificate Number : R0-CEP 2013-114 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2015-10-01
Type : Chemical
Substance Number : 583
Certificate Number : CEP 2017-155 - Rev 01
Status : Valid
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 583
Certificate Number : R1-CEP 2007-295 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2017-04-13
Type : Chemical
Substance Number : 583
Certificate Number : CEP 2017-168 - Rev 01
Status : Valid
Issue Date : 2024-07-16
Type : Chemical
Substance Number : 583
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] NDC API
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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 |
|---|
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FDF Dossiers
Regulatory Info :
Registration Country : Canada
LINCOMYCIN (LINCOMYCIN HYDROCHLORIDE)
Brand Name : LINCOMED 100
Dosage Form : SOLUTION
Dosage Strength : 100MG/ML
Packaging : 100ML
Approval Date :
Application Number : 2424142
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
LINCOMYCIN (LINCOMYCIN HYDROCHLORIDE)
Brand Name : LINCOMYCIN 44 G
Dosage Form : DRUG PREMIX
Dosage Strength : 44G/Kg
Packaging : 25KG
Approval Date :
Application Number : 2091097
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : South Korea
Brand Name : Lincomycin 44
Dosage Form : Premix
Dosage Strength : 44G/KG
Packaging : 1KG, 5KG, 20KG
Approval Date :
Application Number :
Regulatory Info :
Registration Country : South Korea
Regulatory Info : RX
Registration Country : USA
Brand Name : LINCOMYCIN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 300MG BASE/ML
Packaging :
Approval Date : 2022-09-26
Application Number : 215657
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Australia
Brand Name : Lincocin
Dosage Form : injection
Dosage Strength : 600 mg/2 mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Italy
Brand Name : Lincocin
Dosage Form : Lincomycin 600Mg 1 Unit Parenteral Use
Dosage Strength : 1 ampoule injector 600 mg 2 ml + syringe
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Lincocin 600mg
Dosage Form : INJ
Dosage Strength : 600mg/2ml
Packaging : 2X10mg/2ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Sterilized Injection
Dosage Strength : 30G/100ML
Packaging : 50ml/100ml/250ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Regulatory Info :
Registration Country : USA
Brand Name : LINCOMYCIN HCL
Dosage Form : Injectable; Injection
Dosage Strength : EQ 300MG BASE/ML
Packaging :
Approval Date :
Application Number : 62784
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : China
Brand Name : Spec & Linco-150
Dosage Form : Liquid Injection
Dosage Strength : 10%; 5%
Packaging : 100ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : No
TE Code : AP
Brand Name : LINCOMYCIN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 300MG BASE/ML
Approval Date : 2021-11-08
Application Number : 215082
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Brand Name : LINCOCIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 250MG BASE
Approval Date : 1982-01-01
Application Number : 50316
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : LINCOCIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 500MG BASE
Approval Date : 1982-01-01
Application Number : 50316
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD :
TE Code :
Brand Name : LINCOMYCIN HCL
Dosage Form : Injectable; Injection
Dosage Strength : EQ 300MG BASE/ML
Approval Date :
Application Number : 62784
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code :
Brand Name : LINCOMYCIN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 300MG BASE/ML
Approval Date : 2022-12-21
Application Number : 216662
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AP
Brand Name : LINCOMYCIN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 300MG BASE/ML
Approval Date : 2015-06-04
Application Number : 201746
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Brand Name : LINCOMYCIN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 300MG BASE/ML
Approval Date : 1991-04-16
Application Number : 63180
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
RLD : No
TE Code : AP
Brand Name : LINCOMYCIN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 300MG BASE/ML
Approval Date : 2021-03-12
Application Number : 212770
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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
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Nanjing Well Pharmaceutical
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Topical
Solubilizers
Parenteral
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
57
PharmaCompass offers a list of Lincomycin 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 Lincomycin Hydrochloride manufacturer or Lincomycin Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lincomycin Hydrochloride manufacturer or Lincomycin Hydrochloride supplier.
PharmaCompass also assists you with knowing the Lincomycin Hydrochloride API Price utilized in the formulation of products. Lincomycin Hydrochloride API Price is not always fixed or binding as the Lincomycin Hydrochloride Price is obtained through a variety of data sources. The Lincomycin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A U 10149a manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of U 10149a, including repackagers and relabelers. The FDA regulates U 10149a manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. U 10149a 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 U 10149a manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A U 10149a supplier is an individual or a company that provides U 10149a active pharmaceutical ingredient (API) or U 10149a finished formulations upon request. The U 10149a suppliers may include U 10149a API manufacturers, exporters, distributors and traders.
click here to find a list of U 10149a suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A U 10149a DMF (Drug Master File) is a document detailing the whole manufacturing process of U 10149a active pharmaceutical ingredient (API) in detail. Different forms of U 10149a DMFs exist exist since differing nations have different regulations, such as U 10149a USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A U 10149a DMF submitted to regulatory agencies in the US is known as a USDMF. U 10149a USDMF includes data on U 10149a's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The U 10149a USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of U 10149a 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 U 10149a Drug Master File in Japan (U 10149a JDMF) empowers U 10149a 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 U 10149a JDMF during the approval evaluation for pharmaceutical products. At the time of U 10149a 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 U 10149a 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 U 10149a Drug Master File in Korea (U 10149a KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of U 10149a. The MFDS reviews the U 10149a KDMF as part of the drug registration process and uses the information provided in the U 10149a KDMF to evaluate the safety and efficacy of the drug.
After submitting a U 10149a 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 U 10149a API can apply through the Korea Drug Master File (KDMF).
click here to find a list of U 10149a suppliers with KDMF on PharmaCompass.
A U 10149a CEP of the European Pharmacopoeia monograph is often referred to as a U 10149a Certificate of Suitability (COS). The purpose of a U 10149a CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of U 10149a EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of U 10149a to their clients by showing that a U 10149a CEP has been issued for it. The manufacturer submits a U 10149a CEP (COS) as part of the market authorization procedure, and it takes on the role of a U 10149a CEP holder for the record. Additionally, the data presented in the U 10149a CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the U 10149a DMF.
A U 10149a CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. U 10149a 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 U 10149a suppliers with CEP (COS) 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 U 10149a as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for U 10149a 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 U 10149a 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 U 10149a and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a U 10149a NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of U 10149a suppliers with NDC on PharmaCompass.
U 10149a 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 U 10149a 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 U 10149a GMP manufacturer or U 10149a GMP API supplier for your needs.
A U 10149a CoA (Certificate of Analysis) is a formal document that attests to U 10149a's compliance with U 10149a specifications and serves as a tool for batch-level quality control.
U 10149a CoA mostly includes findings from lab analyses of a specific batch. For each U 10149a 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.
U 10149a may be tested according to a variety of international standards, such as European Pharmacopoeia (U 10149a EP), U 10149a JP (Japanese Pharmacopeia) and the US Pharmacopoeia (U 10149a USP).
