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1. Benpen
2. Benzylpenicillin
3. Benzylpenicillin Potassium
4. Coliriocilina
5. Crystapen
6. Or-pen
7. Parcillin
8. Pekamin
9. Pengesod
10. Penibiot
11. Penicilina G Llorente
12. Penicillin G
13. Penicillin G Jenapharm
14. Penicillin G Sodium
15. Penicillin Grnenthal
16. Penilevel
17. Peniroger
18. Pfizerpen
19. Sodiopen
20. Sodipen
21. Sodium Benzylpenicillin
22. Sodium Penicillin
23. Unicilina
24. Ursopen
25. Van-pen-g
1. 113-98-4
2. Benzylpenicillin Potassium
3. Penicillin G Potassium Salt
4. Potassium Benzylpenicillin
5. Potassium Penicillin G
6. Benzylpenicillin Potassium Salt
7. Penicillin G K
8. Pentids
9. Potassium Benzylpenicillinate
10. Pfizerpen
11. Benzylpenicilline Potassique
12. Potassium Salt Of Benzylpenicillin
13. Pfizerpen G
14. Penicillin-2
15. Notaral
16. Pentids '200'
17. Penicillin G (potassium)
18. Benzylpenicillinic Acid Potassium Salt
19. Chebi:7963
20. Penicilline G Potassium
21. Penicillin Potassium G, Crystalline
22. Falapen
23. Vl775zth4c
24. Penicillin G Potassium [usp]
25. Sk-penicillin G
26. Mls000069426
27. Potassium (2s,5r,6r)-3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
28. 6beta-phenylacetamidopenicillanic Acid Potassium Salt
29. Capicillin
30. Eskacillin
31. Hipercilina
32. Sugracillin
33. Cintrisul
34. Cristapen
35. Hyasorb
36. Hylenta
37. Lemopen
38. Liquapen
39. Monopen
40. Penalev
41. Penisem
42. Scotcil
43. Tabilin
44. Forpen
45. Pentid
46. Potassium;(2s,5r,6r)-3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate
47. Smr000059004
48. Tu Cillin
49. C-cillin
50. Paclin G
51. Qidpen G
52. Megacillin Tablets
53. Potassium Benzylpenicillin G
54. Van-pen-g
55. Penicillin G Potassium (usp)
56. Penicilline G Potassium 100 Microg/ml In Acetonitrile/water
57. Novocillin Vet.
58. Potassium 6-(phenylacetamido)penicillanate
59. Monopotassium (2s,5r,6r)-3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate
60. Cilloral Potassium Salt
61. Cosmopen Potassium Salt
62. Nsc-131815
63. Unii-vl775zth4c
64. Penicilline
65. Pentids '250'
66. Pentids '400'
67. Pentids '800'
68. Benzylpenicilline Potassique [dcf]
69. Pfizerpen (tn)
70. Einecs 204-038-0
71. Mfcd00036193
72. Nsc 131815
73. Potassiumbenzylpenicillin
74. Opera_id_1649
75. Penicillin G Potassium In Plastic Container
76. Epitope Id:140781
77. Chembl1223
78. Dsstox_cid_25106
79. Dsstox_rid_80673
80. Dsstox_gsid_45106
81. Schembl34078
82. Mls001076462
83. Spectrum1500465
84. Dtxsid7045106
85. Hms500p18
86. Hms1920f12
87. Hms2091n12
88. Hms2234c21
89. Benzylpenicillin Potassium (jp17)
90. Bcp14289
91. Tox21_110044
92. Ccg-39599
93. Akos008145411
94. Penicillin G Potassium [vandf]
95. Cs-3873
96. Benzylpenicillin Potassium [jan]
97. Penicillin G Potassium [usp-rs]
98. Ncgc00014313-01
99. Penicillin G Potassium Salt [mi]
100. Ac-14408
101. As-75133
102. Benzylpenicillin Potassium [mart.]
103. Cas-113-98-4
104. E705
105. Hy-17591
106. Benzylpenicillin Potassium [who-dd]
107. Benzylpenicillin Potassium [who-ip]
108. Ai3-50119
109. Penicillin G Potassium [green Book]
110. Penicillin G Potassium Salt, ~1600 U/mg
111. P1772
112. Penicillin G Potassium [orange Book]
113. Penicillin G Potassium [usp Monograph]
114. D01053
115. Penicillin G Potassium Salt, Cell Culture Grade
116. Benzylpenicillin Potassium [ep Monograph]
117. Benzylpenicillinum Kalicum [who-ip Latin]
118. Penicillin G Potassium Salt, >=98.0% (hplc)
119. W-108609
120. Penicillin G Potassium 100 Microg/ml In Acetonitrile
121. Q27089370
122. Penicillin G Potassium Salt, Powder, Mouse Embryo Tested
123. Z803129904
124. Penicillin G Potassium Salt, Vetranal(tm), Analytical Standard
125. Penicillin G Potassium, Antibiotic For Culture Media Use Only
126. Benzylpenicillin Potassium, European Pharmacopoeia (ep) Reference Standard
127. Penicillin G Potassium Salt, Meets Usp Testing Specifications, Powder
128. Penicillin G Potassium Salt, Powder, Bioreagent, Suitable For Cell Culture
129. Penicillin G Potassium, United States Pharmacopeia (usp) Reference Standard
130. Potassium 2,2-dimethyl-6beta-(phenylacetamido)penam-3alpha-carboxylate
131. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-6- (2-phenylacetamido)-, Monopotassium Salt
132. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-6-((2-phenylacetyl)amino)- (2s,5r,6r)-, Potassium Salt (1:1)
133. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-6-((phenylacetyl)amino)- (2s,5r,6r)-, Monopotassium Salt
134. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-6-((phenylacetyl)amino)-, Monopotassium Salt, (2s-(2.alpha.,5.alpha.,6.beta.))-
135. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 3,3-dimethyl-7-oxo-6-((phenylacetyl)amino)-, Monopotassium Salt, (2s-(2alpha,5alpha,6beta))-
136. Potassium (2s-(2alpha,5alpha,6beta))-3,3-dimethyl-7-oxo-6-(phenylacetamido)-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylate
| Molecular Weight | 372.5 g/mol |
|---|---|
| Molecular Formula | C16H17KN2O4S |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 4 |
| Exact Mass | 372.05460969 g/mol |
| Monoisotopic Mass | 372.05460969 g/mol |
| Topological Polar Surface Area | 115 Ų |
| Heavy Atom Count | 24 |
| Formal Charge | 0 |
| Complexity | 536 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 3 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Penicillin g potassium |
| Active Ingredient | Penicillin g potassium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 20,000,000 units/vial; 1,000,000 units/vial; 5,000,000 units/vial |
| Market Status | Prescription |
| Company | Istituto Bio Ita Spa; Sandoz; Hanford Gc |
| 2 of 4 | |
|---|---|
| Drug Name | Penicillin g potassium in plastic container |
| PubMed Health | Penicillin G Potassium (Injection) |
| Drug Classes | Antibiotic |
| Drug Label | Penicillin G Potassium, USP is a natural penicillin. It is chemically designated 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-6-[(phenylacetyl)amino]-, monopotassium salt, [2S-(2, 5, 6)]. Penicillin G potassium is... |
| Active Ingredient | Penicillin g potassium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 20,000 units/ml; 40,000 units/ml; 60,000 units/ml |
| Market Status | Prescription |
| Company | Baxter Hlthcare |
| 3 of 4 | |
|---|---|
| Drug Name | Penicillin g potassium |
| Active Ingredient | Penicillin g potassium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 20,000,000 units/vial; 1,000,000 units/vial; 5,000,000 units/vial |
| Market Status | Prescription |
| Company | Istituto Bio Ita Spa; Sandoz; Hanford Gc |
| 4 of 4 | |
|---|---|
| Drug Name | Penicillin g potassium in plastic container |
| PubMed Health | Penicillin G Potassium (Injection) |
| Drug Classes | Antibiotic |
| Drug Label | Penicillin G Potassium, USP is a natural penicillin. It is chemically designated 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-6-[(phenylacetyl)amino]-, monopotassium salt, [2S-(2, 5, 6)]. Penicillin G potassium is... |
| Active Ingredient | Penicillin g potassium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 20,000 units/ml; 40,000 units/ml; 60,000 units/ml |
| Market Status | Prescription |
| Company | Baxter Hlthcare |
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 : 13326
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11041
Submission : 1994-06-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12490
Submission : 1997-03-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12094
Submission : 1996-08-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12523
Submission : 1997-05-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10234
Submission : 1993-05-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12389
Submission : 1997-02-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13222
Submission : 1998-04-30
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13236
Submission : 1998-09-01
Status : Inactive
Type : II
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12858
Submission : 1998-02-11
Status : Inactive
Type : II
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Benzylpenicillin (procaine) Monohydrate, Lecithi...
Certificate Number : CEP 1999-017 - Rev 05
Status : Valid
Issue Date : 2023-09-22
Type : Chemical
Substance Number : 115
Benzylpenicillin Potassium, Sterile
Certificate Number : R1-CEP 2001-395 - Rev 03
Status : Valid
Issue Date : 2019-11-20
Type : Chemical
Substance Number : 113
Seed Agar, Penicillin Assay, (Product Codes: 210...
Certificate Number : R0-CEP 2000-380 - Rev 01
Status : Expired
Issue Date : 2005-02-22
Type : TSE
Substance Number :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Benzylpenicillin benzathine, 1% lecithin (sterile)
Registration Number : 231MF10072
Registrant's Address : Biochemiesstrasse 10, 6250 Kundl, Austria
Initial Date of Registration : 2019-03-12
Latest Date of Registration : 2024-02-21
Benzylpenicillin Benzathine (1% lecithin, 0.2% Tween)
Registration Number : 229MF10169
Registrant's Address : Biochemiesstrasse 10,6250 Kundl, Austria
Initial Date of Registration : 2017-08-28
Latest Date of Registration : 2019-10-25
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Average Price (USD/KGS) |
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Drugs in Development
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Regulatory Info :
Registration Country : Norway
Brand Name : Penicillin Actavis
Dosage Form : Powder for injection/infusion fluid, resolution
Dosage Strength : 1.2 g
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Penicillin Actavis
Dosage Form : Powder for injection/infusion fluid, resolution
Dosage Strength : 6 g
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Penicillin Actavis
Dosage Form : Powder for injection/infusion fluid, resolution
Dosage Strength : 600 mg
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Sweden
Brand Name : benzylpenicillin Panpharma
Dosage Form : POWDER FOR INJECTION / INFUSION
Dosage Strength : -
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Benzylpenicillin Panpharma
Dosage Form : Powder for injection/infusion fluid, resolution
Dosage Strength : 0.6 g
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Benzylpenicillin Panpharma
Dosage Form : Powder for injection/infusion fluid, resolution
Dosage Strength : 3 g
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Benzylpenicillin Panpharma
Dosage Form : Powder for injection/infusion fluid, resolution
Dosage Strength : 6 g
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Sweden
Brand Name : bensylpenicillin MEDA
Dosage Form : POWDER FOR INJECTION / INFUSION
Dosage Strength : -
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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Regulatory Info :
Registration Country : Spain
Brand Name : Penibiot \"5\" 1 5000000Iu Injection
Dosage Form : Injection
Dosage Strength : 125 Mg/Injection
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
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Regulatory Info :
Registration Country : Spain
Brand Name : 5,000 Penilevel 000Iu Injection
Dosage Form : Injection
Dosage Strength : 125 Mg/Injection
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
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Regulatory Info :
Registration Country : Australia
Brand Name : BenPen
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : BenPen
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : BenPen
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : BenPen
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : BenPen
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : BenPen
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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RX/OTC/DISCN : Class A
Dosage Form : Benzylpenicillin Benzathine 1.20...
Dosage Strength : 1 syringe 1,200,000 IU 2.5 ml
Price Per Pack (Euro) : 16.25
Published in :
Country : Italy
RX/OTC/DISCN : Class A
RX/OTC/DISCN :
Dosage Form : Powder for injection/infusion fl...
Dosage Strength : 1.2 g
Price Per Pack (Euro) : 18.59
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Powder for injection/infusion fl...
Dosage Strength : 600 mg
Price Per Pack (Euro) : 13.035
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Powder for injection/infusion fl...
Dosage Strength : 3 g
Price Per Pack (Euro) : 39.061
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Powder for injection/infusion fl...
Dosage Strength : 6 g
Price Per Pack (Euro) : 61.556
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Powder for injection/infusion fl...
Dosage Strength : 0.6 g
Price Per Pack (Euro) : 12.32
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Powder for injection/infusion fl...
Dosage Strength : 1.2 g
Price Per Pack (Euro) : 17.446
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Injection
Dosage Strength : 125 Mg/Injection
Price Per Pack (Euro) : 1.83
Published in :
Country : Spain
RX/OTC/DISCN :
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RX/OTC/DISCN :
Dosage Form : Injection
Dosage Strength : 125 Mg/Injection
Price Per Pack (Euro) : 1.83
Published in :
Country : Spain
RX/OTC/DISCN :
Portfolio PDF
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RX/OTC/DISCN :
Dosage Form : Injection
Dosage Strength : 125 Mg/Injection
Price Per Pack (Euro) : 2.69
Published in :
Country : Spain
RX/OTC/DISCN :
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FDF DOSSIERS
Reply
12 Jan 2022
Reply
03 May 2021
Reply
28 Sep 2016
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
30
PharmaCompass offers a list of Penicillin G Potassium 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 Penicillin G Potassium manufacturer or Penicillin G Potassium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Penicillin G Potassium manufacturer or Penicillin G Potassium supplier.
PharmaCompass also assists you with knowing the Penicillin G Potassium API Price utilized in the formulation of products. Penicillin G Potassium API Price is not always fixed or binding as the Penicillin G Potassium Price is obtained through a variety of data sources. The Penicillin G Potassium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A PENTIDS 400 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PENTIDS 400, including repackagers and relabelers. The FDA regulates PENTIDS 400 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PENTIDS 400 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 PENTIDS 400 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PENTIDS 400 supplier is an individual or a company that provides PENTIDS 400 active pharmaceutical ingredient (API) or PENTIDS 400 finished formulations upon request. The PENTIDS 400 suppliers may include PENTIDS 400 API manufacturers, exporters, distributors and traders.
click here to find a list of PENTIDS 400 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PENTIDS 400 DMF (Drug Master File) is a document detailing the whole manufacturing process of PENTIDS 400 active pharmaceutical ingredient (API) in detail. Different forms of PENTIDS 400 DMFs exist exist since differing nations have different regulations, such as PENTIDS 400 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PENTIDS 400 DMF submitted to regulatory agencies in the US is known as a USDMF. PENTIDS 400 USDMF includes data on PENTIDS 400's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PENTIDS 400 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PENTIDS 400 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 PENTIDS 400 Drug Master File in Japan (PENTIDS 400 JDMF) empowers PENTIDS 400 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 PENTIDS 400 JDMF during the approval evaluation for pharmaceutical products. At the time of PENTIDS 400 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 PENTIDS 400 suppliers with JDMF on PharmaCompass.
A PENTIDS 400 CEP of the European Pharmacopoeia monograph is often referred to as a PENTIDS 400 Certificate of Suitability (COS). The purpose of a PENTIDS 400 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PENTIDS 400 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PENTIDS 400 to their clients by showing that a PENTIDS 400 CEP has been issued for it. The manufacturer submits a PENTIDS 400 CEP (COS) as part of the market authorization procedure, and it takes on the role of a PENTIDS 400 CEP holder for the record. Additionally, the data presented in the PENTIDS 400 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PENTIDS 400 DMF.
A PENTIDS 400 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PENTIDS 400 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 PENTIDS 400 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 PENTIDS 400 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PENTIDS 400 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 PENTIDS 400 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 PENTIDS 400 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PENTIDS 400 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PENTIDS 400 suppliers with NDC on PharmaCompass.
PENTIDS 400 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 PENTIDS 400 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 PENTIDS 400 GMP manufacturer or PENTIDS 400 GMP API supplier for your needs.
A PENTIDS 400 CoA (Certificate of Analysis) is a formal document that attests to PENTIDS 400's compliance with PENTIDS 400 specifications and serves as a tool for batch-level quality control.
PENTIDS 400 CoA mostly includes findings from lab analyses of a specific batch. For each PENTIDS 400 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.
PENTIDS 400 may be tested according to a variety of international standards, such as European Pharmacopoeia (PENTIDS 400 EP), PENTIDS 400 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PENTIDS 400 USP).
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