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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
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12558
Submission : 1997-06-17
Status : Active
Type : II
NDC Package Code : 63278-1056
Start Marketing Date : 2000-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-30
Pay. Date : 2013-01-04
DMF Number : 14603
Submission : 1999-11-23
Status : Active
Type : II
Certificate Number : R1-CEP 2008-069 - Rev 05
Issue Date : 2023-08-21
Type : Chemical
Substance Number : 1755
Status : Valid
Date of Issue : 2022-09-30
Valid Till : 2025-11-30
Written Confirmation Number : WC-390A4
Address of the Firm :
NDC Package Code : 55111-014
Start Marketing Date : 1999-11-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hana Pharmaceutical Co., Ltd.
Registration Date : 2018-08-13
Registration Number : 20050831-61-C-189-04(8)
Manufacturer Name : Dr. Reddy's Laboratories Ltd.
Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri Venkateswara Co-operative Industrial Estate Bollaram, Village, Jinnaram Mandal, Sangareddy District, Telangana, 502325, India
| Available Reg Filing : CN, BR, RU |
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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.4%
USFDA APPLICATION NUMBER - 21528
DOSAGE - SPRAY, METERED;NASAL - 15.75MG/SPRAY
USFDA APPLICATION NUMBER - 22382
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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 Dolac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dolac, including repackagers and relabelers. The FDA regulates Dolac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dolac 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 Dolac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dolac supplier is an individual or a company that provides Dolac active pharmaceutical ingredient (API) or Dolac finished formulations upon request. The Dolac suppliers may include Dolac API manufacturers, exporters, distributors and traders.
click here to find a list of Dolac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dolac DMF (Drug Master File) is a document detailing the whole manufacturing process of Dolac active pharmaceutical ingredient (API) in detail. Different forms of Dolac DMFs exist exist since differing nations have different regulations, such as Dolac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dolac DMF submitted to regulatory agencies in the US is known as a USDMF. Dolac USDMF includes data on Dolac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dolac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dolac 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 Dolac Drug Master File in Korea (Dolac KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dolac. The MFDS reviews the Dolac KDMF as part of the drug registration process and uses the information provided in the Dolac KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dolac 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 Dolac API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dolac suppliers with KDMF on PharmaCompass.
A Dolac CEP of the European Pharmacopoeia monograph is often referred to as a Dolac Certificate of Suitability (COS). The purpose of a Dolac CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dolac EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dolac to their clients by showing that a Dolac CEP has been issued for it. The manufacturer submits a Dolac CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dolac CEP holder for the record. Additionally, the data presented in the Dolac CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dolac DMF.
A Dolac CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dolac 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 Dolac suppliers with CEP (COS) on PharmaCompass.
A Dolac written confirmation (Dolac WC) is an official document issued by a regulatory agency to a Dolac manufacturer, verifying that the manufacturing facility of a Dolac active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dolac APIs or Dolac finished pharmaceutical products to another nation, regulatory agencies frequently require a Dolac WC (written confirmation) as part of the regulatory process.
click here to find a list of Dolac 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 Dolac as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dolac 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 Dolac 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 Dolac and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dolac NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dolac suppliers with NDC on PharmaCompass.
Dolac 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 Dolac 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 Dolac GMP manufacturer or Dolac GMP API supplier for your needs.
A Dolac CoA (Certificate of Analysis) is a formal document that attests to Dolac's compliance with Dolac specifications and serves as a tool for batch-level quality control.
Dolac CoA mostly includes findings from lab analyses of a specific batch. For each Dolac 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.
Dolac may be tested according to a variety of international standards, such as European Pharmacopoeia (Dolac EP), Dolac JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dolac USP).
