Synopsis
Synopsis
0
JDMF
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. Acular
2. Toradol
1. 74103-07-4
2. Ketorolac Tris Salt
3. Toradol
4. Acular
5. Ketorolac (tromethamine Salt)
6. Ketorolac Tromethamine Salt
7. Ketorolac Trometamol
8. Acular Ls
9. Acuvail
10. Lixidol
11. Acular Pf
12. Sprix
13. Dolac
14. Tarasyn
15. Ketorolac (toradol)
16. 2-amino-2-(hydroxymethyl)propane-1,3-diol 5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylate
17. Nsc-758637
18. 4eve5946bq
19. Syntex
20. Toradol (tn)
21. (+/-)-5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylic Acid Tris Salt
22. 2-amino-2-(hydroxymethyl)propane-1,3-diol;5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylic Acid
23. Godek
24. Acular Preservative Free
25. Ketorolac Tromethamine;ketorolac Tris Salt;rs37619 Tromethamine Salt
26. Chebi:6130
27. Smr000058461
28. Ketorolac Tromethamine [usan]
29. Tromethamine Ketorolac
30. Sr-01000075948
31. Rs-37619
32. Unii-4eve5946bq
33. Toratex
34. Droal
35. Ketorolactrissalt
36. Tora-dol
37. Ketorolac Tromethamine [usan:usp]
38. Acular (tn)
39. Mfcd00887595
40. Bppc
41. Spectrum_001578
42. Cpd000058461
43. Ketorolac Tromethamine Ophthalmic Solution
44. Prestwick0_000929
45. Prestwick1_000929
46. Prestwick2_000929
47. Prestwick3_000929
48. Spectrum2_001598
49. Spectrum3_001975
50. Spectrum4_000215
51. Spectrum5_001273
52. Ketrolac.tromethamine Salt
53. Schembl5036
54. Lopac0_000676
55. Bspbio_000838
56. Bspbio_003575
57. Kbiogr_000849
58. Kbioss_002058
59. (+-)-5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylic Acid, Compound With 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)
60. 2-amino-2-(hydroxymethyl)propane-1,3-diol; 5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylic Acid
61. Ketorolac Tromethamine (usp)
62. Mls000069689
63. Mls001401455
64. Mls002222310
65. Divk1c_000836
66. Spectrum1503925
67. Spbio_001596
68. Spbio_003017
69. Bpbio1_000922
70. Chembl1201124
71. Dtxsid0045597
72. Hms502j18
73. Kbio1_000836
74. Kbio2_002058
75. Kbio2_004626
76. Kbio2_007194
77. Kbio3_002953
78. Rox-828
79. Rox-888
80. Ninds_000836
81. Hms1570j20
82. Hms1922k22
83. Hms2051p06
84. Hms2093m05
85. Hms2097j20
86. Hms2235n13
87. Hms3262g13
88. Hms3373m06
89. Hms3393p06
90. Hms3655e15
91. Hms3714j20
92. Ketorolac Trometamol [jan]
93. Pharmakon1600-01503925
94. Bcp02917
95. Hy-b0138
96. (+/-)-ketorolac Tromethamine Salt
97. Tox21_500676
98. Ccg-39376
99. Ketorolac Trometamol [mart.]
100. Nsc758637
101. S5698
102. Ketorolac Tromethamine [vandf]
103. Akos024386301
104. Bcp9000811
105. Ccg-101006
106. Cs-1933
107. Ketorolac Tromethamine [usp-rs]
108. Ketorolac Tromethamine [who-dd]
109. Lp00676
110. Nc00256
111. Nsc 758637
112. Idi1_000836
113. Ncgc00016159-02
114. Ncgc00016159-03
115. Ncgc00016159-04
116. Ncgc00094036-01
117. Ncgc00094036-02
118. Ncgc00094036-03
119. Ncgc00261361-01
120. 1h-pyrrolizine-1-carboxylic Acid, 5-benzoyl-2,3-dihydro, (+-)-, Compound With 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)
121. As-15193
122. Ketorolac Tris Salt;ketorolac Tromethamine
123. Bcp0726000301
124. Ketorolac Tris Salt, >=99%, Crystalline
125. Ketorolac Trometamol [ep Monograph]
126. Db-055837
127. Ketorolac Trometamol For Peak Identification
128. Ketorolac Tromethamine [orange Book]
129. Eu-0100676
130. Ft-0630829
131. K0053
132. Sw197293-4
133. Ketorolac Tromethamine [usp Monograph]
134. D00813
135. K 1136
136. M02042
137. Omidria Component Ketorolac Tromethamine
138. 103k074
139. A838011
140. Ketorolac Tromethamine Component Of Omidria
141. Sr-01000946595
142. Q-201269
143. Sr-01000075948-1
144. Sr-01000075948-6
145. Sr-01000075948-8
146. Sr-01000946595-1
147. Ketorolac (+/-)-form Tromethamine Salt [mi]
148. Q27107089
149. F0001-2390
150. Ketorolac Trometamol 1.0 Mg/ml In Methanol (as Free Acid)
151. Ketorolac Trometamol, European Pharmacopoeia (ep) Reference Standard
152. Ketorolac Tromethamine, United States Pharmacopeia (usp) Reference Standard
153. Ketorolac Trometamol For Peak Identification, European Pharmacopoeia (ep) Reference Standard
154. Ketorolac Tromethamine, Pharmaceutical Secondary Standard; Certified Reference Material
155. (+/-)-5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylic Acid, Compound With 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)
156. 1h-pyrrolizine-1-1h-pyrrolizine-1-carboxylic Acid, 5-benzoyl-2,3-dihydro, (+/-)-, Compound With 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)
157. 2-amino-2-(hydroxymethyl)propane-1,3-diol (1rs)-5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylate
158. 5-benzoyl-2,3-dihydro-1h-pyrrolizine-1-carboxylate; 2-hydroxyethyl-bis(hydroxymethyl)ammonium;ketorolac Tromethamine
1. Trometamol Ketorolac
| Molecular Weight | 376.4 g/mol |
|---|---|
| Molecular Formula | C19H24N2O6 |
| Hydrogen Bond Donor Count | 5 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 6 |
| Exact Mass | 376.16343649 g/mol |
| Monoisotopic Mass | 376.16343649 g/mol |
| Topological Polar Surface Area | 146 Ų |
| Heavy Atom Count | 27 |
| Formal Charge | 0 |
| Complexity | 430 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 10 | |
|---|---|
| Drug Name | Acular |
| PubMed Health | Ketorolac |
| Drug Classes | Analgesic, Central Nervous System Agent, Ophthalmologic Agent |
| Drug Label | ACULAR (ketorolac tromethamine ophthalmic solution) is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is ()-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, comp... |
| Active Ingredient | Ketorolac tromethamine |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 0.5% |
| Market Status | Prescription |
| Company | Allergan |
| 2 of 10 | |
|---|---|
| Drug Name | Acular ls |
| PubMed Health | Ketorolac (Into the eye) |
| Drug Classes | Ophthalmologic Agent |
| Drug Label | ACULAR LS (ketorolac tromethamine ophthalmic solution) 0.4% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Structural and Molecular Formula: C19H24N2O6Mol Wt 376.40Chemical Name... |
| Active Ingredient | Ketorolac tromethamine |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 0.4% |
| Market Status | Prescription |
| Company | Allergan |
| 3 of 10 | |
|---|---|
| Drug Name | Acuvail |
| PubMed Health | Ketorolac |
| Drug Classes | Analgesic, Central Nervous System Agent, Ophthalmologic Agent |
| Drug Label | ACUVAIL (ketorolac tromethamine ophthalmic solution) 0.45% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is ()-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic aci... |
| Active Ingredient | Ketorolac tromethamine |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 0.45% |
| Market Status | Prescription |
| Company | Allergan |
| 4 of 10 | |
|---|---|
| Drug Name | Ketorolac tromethamine |
| Drug Label | Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural form... |
| Active Ingredient | Ketorolac tromethamine |
| Dosage Form | Solution/drops; Tablet; Injectable |
| Route | injection; Ophthalmic; Injection; Oral |
| Strength | 0.5%; 0.4%; 30mg/ml; 60mg/2ml; 10mg; 15mg/ml |
| Market Status | Prescription |
| Company | Wockhardt; Hospira; Gland Pharma; Teva; Apotex; Sandoz; Sun Pharma Global; Fresenius Kabi Usa; Hikma Maple; Alcon Pharms; Amphastar Pharm; Sagent Pharms; Pliva; Agila Speclts; Mylan; Akorn |
| 5 of 10 | |
|---|---|
| Drug Name | Sprix |
| Drug Label | Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is ()-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hy... |
| Active Ingredient | Ketorolac tromethamine |
| Dosage Form | Spray, metered |
| Route | Nasal |
| Strength | 15.75mg/spray |
| Market Status | Prescription |
| Company | Luitpold |
| 6 of 10 | |
|---|---|
| Drug Name | Acular |
| PubMed Health | Ketorolac |
| Drug Classes | Analgesic, Central Nervous System Agent, Ophthalmologic Agent |
| Drug Label | ACULAR (ketorolac tromethamine ophthalmic solution) is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is ()-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, comp... |
| Active Ingredient | Ketorolac tromethamine |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 0.5% |
| Market Status | Prescription |
| Company | Allergan |
| 7 of 10 | |
|---|---|
| Drug Name | Acular ls |
| PubMed Health | Ketorolac (Into the eye) |
| Drug Classes | Ophthalmologic Agent |
| Drug Label | ACULAR LS (ketorolac tromethamine ophthalmic solution) 0.4% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Structural and Molecular Formula: C19H24N2O6Mol Wt 376.40Chemical Name... |
| Active Ingredient | Ketorolac tromethamine |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 0.4% |
| Market Status | Prescription |
| Company | Allergan |
| 8 of 10 | |
|---|---|
| Drug Name | Acuvail |
| PubMed Health | Ketorolac |
| Drug Classes | Analgesic, Central Nervous System Agent, Ophthalmologic Agent |
| Drug Label | ACUVAIL (ketorolac tromethamine ophthalmic solution) 0.45% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is ()-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic aci... |
| Active Ingredient | Ketorolac tromethamine |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | 0.45% |
| Market Status | Prescription |
| Company | Allergan |
| 9 of 10 | |
|---|---|
| Drug Name | Ketorolac tromethamine |
| Drug Label | Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural form... |
| Active Ingredient | Ketorolac tromethamine |
| Dosage Form | Solution/drops; Tablet; Injectable |
| Route | injection; Ophthalmic; Injection; Oral |
| Strength | 0.5%; 0.4%; 30mg/ml; 60mg/2ml; 10mg; 15mg/ml |
| Market Status | Prescription |
| Company | Wockhardt; Hospira; Gland Pharma; Teva; Apotex; Sandoz; Sun Pharma Global; Fresenius Kabi Usa; Hikma Maple; Alcon Pharms; Amphastar Pharm; Sagent Pharms; Pliva; Agila Speclts; Mylan; Akorn |
| 10 of 10 | |
|---|---|
| Drug Name | Sprix |
| Drug Label | Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is ()-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hy... |
| Active Ingredient | Ketorolac tromethamine |
| Dosage Form | Spray, metered |
| Route | Nasal |
| Strength | 15.75mg/spray |
| Market Status | Prescription |
| Company | Luitpold |
Investigated for use/treatment in pain (acute or chronic).
Cyclooxygenase Inhibitors
Compounds or agents that combine with cyclooxygenase (PROSTAGLANDIN-ENDOPEROXIDE SYNTHASES) and thereby prevent its substrate-enzyme combination with arachidonic acid and the formation of eicosanoids, prostaglandins, and thromboxanes. (See all compounds classified as Cyclooxygenase Inhibitors.)
Anti-Inflammatory Agents, Non-Steroidal
Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)
ROX-888 is a intranasal formulation of the broadly used injectible analgesic, ketorolac. It has ability to provide effective analgesia in acute medical conditions resulting in moderate-severe pain, without the disabling side effects of opioid analgesics
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
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]INTERMEDIATE SUPPLIERS
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]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.4%
USFDA APPLICATION NUMBER - 21528
DOSAGE - SPRAY, METERED;NASAL - 15.75MG/SPRAY
USFDA APPLICATION NUMBER - 22382
Related Excipient Companies
EUROAPI
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]Faran Shimi Pharmaceutical
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]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]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]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]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]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]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]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]Excipients by Applications
Coating Systems & Additives
Fillers, Diluents & Binders
Controlled & Modified Release
Thickeners and Stabilizers
Granulation
Direct Compression
Disintegrants & Superdisintegrants
Topical
Lubricants & Glidants
Film Formers & Plasticizers
Parenteral
Solubilizers
Rheology Modifiers
Co-Processed Excipients
Taste Masking
Empty Capsules
Vegetarian Capsules
API Stability Enhancers
Coloring Agents
Emulsifying Agents
Chewable & Orodispersible Aids
Surfactant & Foaming Agents
Digital Content
DATA COMPILATION #PharmaFlow
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
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
75
PharmaCompass offers a list of Ketorolac Trometamol 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 Ketorolac Trometamol manufacturer or Ketorolac Trometamol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ketorolac Trometamol manufacturer or Ketorolac Trometamol supplier.
PharmaCompass also assists you with knowing the Ketorolac Trometamol API Price utilized in the formulation of products. Ketorolac Trometamol API Price is not always fixed or binding as the Ketorolac Trometamol Price is obtained through a variety of data sources. The Ketorolac Trometamol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A BPPC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BPPC, including repackagers and relabelers. The FDA regulates BPPC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BPPC 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 BPPC manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BPPC supplier is an individual or a company that provides BPPC active pharmaceutical ingredient (API) or BPPC finished formulations upon request. The BPPC suppliers may include BPPC API manufacturers, exporters, distributors and traders.
click here to find a list of BPPC suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BPPC DMF (Drug Master File) is a document detailing the whole manufacturing process of BPPC active pharmaceutical ingredient (API) in detail. Different forms of BPPC DMFs exist exist since differing nations have different regulations, such as BPPC USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BPPC DMF submitted to regulatory agencies in the US is known as a USDMF. BPPC USDMF includes data on BPPC's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BPPC USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BPPC suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a BPPC Drug Master File in Korea (BPPC KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BPPC. The MFDS reviews the BPPC KDMF as part of the drug registration process and uses the information provided in the BPPC KDMF to evaluate the safety and efficacy of the drug.
After submitting a BPPC 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 BPPC API can apply through the Korea Drug Master File (KDMF).
click here to find a list of BPPC suppliers with KDMF on PharmaCompass.
A BPPC CEP of the European Pharmacopoeia monograph is often referred to as a BPPC Certificate of Suitability (COS). The purpose of a BPPC CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of BPPC EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of BPPC to their clients by showing that a BPPC CEP has been issued for it. The manufacturer submits a BPPC CEP (COS) as part of the market authorization procedure, and it takes on the role of a BPPC CEP holder for the record. Additionally, the data presented in the BPPC CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the BPPC DMF.
A BPPC CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. BPPC 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 BPPC suppliers with CEP (COS) on PharmaCompass.
A BPPC written confirmation (BPPC WC) is an official document issued by a regulatory agency to a BPPC manufacturer, verifying that the manufacturing facility of a BPPC active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BPPC APIs or BPPC finished pharmaceutical products to another nation, regulatory agencies frequently require a BPPC WC (written confirmation) as part of the regulatory process.
click here to find a list of BPPC 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 BPPC as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for BPPC 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 BPPC 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 BPPC and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BPPC NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of BPPC suppliers with NDC on PharmaCompass.
BPPC 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 BPPC 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 BPPC GMP manufacturer or BPPC GMP API supplier for your needs.
A BPPC CoA (Certificate of Analysis) is a formal document that attests to BPPC's compliance with BPPC specifications and serves as a tool for batch-level quality control.
BPPC CoA mostly includes findings from lab analyses of a specific batch. For each BPPC 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.
BPPC may be tested according to a variety of international standards, such as European Pharmacopoeia (BPPC EP), BPPC JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BPPC USP).
