Synopsis
Synopsis
0
CEP/COS
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. 11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic Acid
2. 4679, Kw
3. Hydrochloride, Olopatadine
4. Kw 4679
5. Kw 4943a
6. Kw-4679
7. Kw-4943a
8. Kw4943a
9. Olopatadine
10. Patanol
1. 140462-76-6
2. Olopatadine Hcl
3. Allelock
4. Pataday
5. Patanase
6. Alo4943a
7. Pazeo
8. Kw4679
9. Kw-4679
10. Olopatadine (hydrochloride)
11. Alo-4943a
12. (z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)acetic Acid Hydrochloride
13. Olopatadine (as Hydrochloride)
14. 2xg66w44kf
15. Dsstox_cid_26486
16. Dsstox_rid_81657
17. Dsstox_gsid_46486
18. Dibenz(b,e)oxepin-2-acetic Acid, 11-(3-(dimethylamino)propylidene)-6,11-dihydro-, Hydrochloride, (z)-
19. Olopine
20. Patadine
21. Olopax
22. Chembl1719
23. Kw 4679
24. Cas-140462-76-6
25. Opatanol (tn)
26. Unii-2xg66w44kf
27. Sr-01000763388
28. Alo 4943a
29. Olopatadine Hydrochloride [usan]
30. Allelock (tn)
31. Patanol (tn)
32. De 114
33. Mfcd00875716
34. Olopatadine Hydrochloride [usan:usp]
35. Olopatadine Hydrochlorde
36. O-ppds
37. Ncgc00164623-01
38. Schembl23213
39. Mls001401465
40. Dtxsid0046486
41. Chebi:31933
42. Hy-b0426a
43. Olopatadine Hydrochloride- Bio-x
44. Al4943a
45. Alo4943a;kw4679
46. 2-[(11z)-11-[3-(dimethylamino)propylidene]-6h-benzo[c][1]benzoxepin-2-yl]acetic Acid;hydrochloride
47. Dibenz[b,e]oxepin-2-acetic Acid, 11-[3-(dimethylamino)propylidene]-6,11-dihydro-, Hydrochloride (1:1), (11z)-
48. Ex-a1347
49. Olopatadine Hydrochloride (opatanol)
50. Tox21_112242
51. S2494
52. Olopatadine Hydrochloride [mi]
53. Akos015895232
54. Akos025149118
55. Olopatadine Hydrochloride (jp17/usp)
56. Tox21_112242_1
57. Bcp9001022
58. Ccg-101141
59. H06o056
60. Ks-1228
61. Nc00391
62. Olopatadine Hydrochloride [jan]
63. Ncgc00263532-01
64. Olopatadine Hydrochloride [mart.]
65. Olopatadine Hydrochloride [vandf]
66. 11-((z)-3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic Acid Hydrochloride
67. 11-((z)-3-(dimethylamino)propylidene)-6,11-dihydrodibenz(b,e)oxepin-2-acetic Acid, Hydrochloride
68. Bo164171
69. Dibenz(b,e)oxepin-2-acetic Acid, 11-(3-dimethylamino)propylidene)-6,11-dihydro-, Hydrochloride, (z)-
70. Olopatadine Hydrochloride [usp-rs]
71. Olopatadine Hydrochloride [who-dd]
72. Smr000469220
73. Olopatadine Hydrochloride, >=98% (hplc)
74. Olopatadine Hydrochloride [ema Epar]
75. O0361
76. C72607
77. D01192
78. Olopatadine Hydrochloride [orange Book]
79. Olopatadine Hydrochloride [usp Monograph]
80. A807652
81. Ryaltris Component Olopatadine Hydrochloride
82. Q-201511
83. Sr-01000763388-4
84. Olopatadine Hydrochloride Component Of Ryaltris
85. Q27255766
86. Olopatadine Hydrochloride, United States Pharmacopeia (usp) Reference Standard
87. (z)-11-[3-(dimethylamino)propylidene]-6,11-dihydro-dibenz[b,e]oxepin-2-acetic Acid Hydrochloride
88. (z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)aceticacidhydrochloride
| Molecular Weight | 373.9 g/mol |
|---|---|
| Molecular Formula | C21H24ClNO3 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 5 |
| Exact Mass | 373.1444713 g/mol |
| Monoisotopic Mass | 373.1444713 g/mol |
| Topological Polar Surface Area | 49.8 Ų |
| Heavy Atom Count | 26 |
| Formal Charge | 0 |
| Complexity | 488 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 8 | |
|---|---|
| Drug Name | Olopatadine hydrochloride |
| Drug Label | Olopatadine Hydrochloride Nasal Solution (Nasal Spray), 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Solution (Nasal Spray), is a wh... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Solution/drops; Spray, metered; Solution |
| Route | Ophthalmic; Nasal; ophthalmic |
| Strength | 0.665mg/spray; 0.2% base; 0.1%; eq 0.1% base; 0.2% |
| Market Status | Tentative Approval; Prescription |
| Company | Wockhardt; Apotex; Sandoz; Watson Labs; Barr |
| 2 of 8 | |
|---|---|
| Drug Name | Pataday |
| Drug Label | PATADAY (olopatadine hydrochloride ophthalmic solution) 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes.Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular we... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.2% base |
| Market Status | Prescription |
| Company | Alcon Pharms |
| 3 of 8 | |
|---|---|
| Drug Name | Patanase |
| PubMed Health | Olopatadine (Into the nose) |
| Drug Classes | Nasal Agent |
| Drug Label | PATANASE (olopatadine hydrochloride) Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of PATANASE Nasal Spray, is a white, water-soluble crystalline powder. T... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Spray, metered |
| Route | Nasal |
| Strength | 0.665mg/spray |
| Market Status | Prescription |
| Company | Alcon Pharms |
| 4 of 8 | |
|---|---|
| Drug Name | Patanol |
| PubMed Health | Olopatadine |
| Drug Classes | Nasal Agent, Ophthalmologic Agent |
| Drug Label | PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.1% base |
| Market Status | Prescription |
| Company | Alcon |
| 5 of 8 | |
|---|---|
| Drug Name | Olopatadine hydrochloride |
| Drug Label | Olopatadine Hydrochloride Nasal Solution (Nasal Spray), 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of Olopatadine Hydrochloride Nasal Solution (Nasal Spray), is a wh... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Solution/drops; Spray, metered; Solution |
| Route | Ophthalmic; Nasal; ophthalmic |
| Strength | 0.665mg/spray; 0.2% base; 0.1%; eq 0.1% base; 0.2% |
| Market Status | Tentative Approval; Prescription |
| Company | Wockhardt; Apotex; Sandoz; Watson Labs; Barr |
| 6 of 8 | |
|---|---|
| Drug Name | Pataday |
| Drug Label | PATADAY (olopatadine hydrochloride ophthalmic solution) 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes.Olopatadine hydrochloride is a white, crystalline, water-soluble powder with a molecular we... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.2% base |
| Market Status | Prescription |
| Company | Alcon Pharms |
| 7 of 8 | |
|---|---|
| Drug Name | Patanase |
| PubMed Health | Olopatadine (Into the nose) |
| Drug Classes | Nasal Agent |
| Drug Label | PATANASE (olopatadine hydrochloride) Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of PATANASE Nasal Spray, is a white, water-soluble crystalline powder. T... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Spray, metered |
| Route | Nasal |
| Strength | 0.665mg/spray |
| Market Status | Prescription |
| Company | Alcon Pharms |
| 8 of 8 | |
|---|---|
| Drug Name | Patanol |
| PubMed Health | Olopatadine |
| Drug Classes | Nasal Agent, Ophthalmologic Agent |
| Drug Label | PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to... |
| Active Ingredient | Olopatadine hydrochloride |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.1% base |
| Market Status | Prescription |
| Company | Alcon |
Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
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.)
Histamine H1 Antagonists, Non-Sedating
A class of non-sedating drugs that bind to but do not activate histamine receptors (DRUG INVERSE AGONISM), thereby blocking the actions of histamine or histamine agonists. These antihistamines represent a heterogenous group of compounds with differing chemical structures, adverse effects, distribution, and metabolism. Compared to the early (first generation) antihistamines, these non-sedating antihistamines have greater receptor specificity, lower penetration of BLOOD-BRAIN BARRIER, and are less likely to cause drowsiness or psychomotor impairment. (See all compounds classified as Histamine H1 Antagonists, Non-Sedating.)
Anti-Allergic Agents
Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)
S01GX09
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]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 - EQ 0.7% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.7% BASE
USFDA APPLICATION NUMBER - 206276
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.1% BASE
USFDA APPLICATION NUMBER - 20688
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.2% BASE
USFDA APPLICATION NUMBER - 21545
DOSAGE - SPRAY, METERED;NASAL - 0.665MG/SPRAY...DOSAGE - SPRAY, METERED;NASAL - 0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21861
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
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]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]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]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]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]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
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]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Coating Systems & Additives
Fillers, Diluents & Binders
Controlled & Modified Release
Direct Compression
Taste Masking
Chewable & Orodispersible Aids
Parenteral
Solubilizers
Granulation
Disintegrants & Superdisintegrants
Film Formers & Plasticizers
Co-Processed Excipients
Thickeners and Stabilizers
Empty Capsules
Vegetarian Capsules
API Stability Enhancers
Rheology Modifiers
Topical
Coloring Agents
Lubricants & Glidants
Surfactant & Foaming Agents
Emulsifying Agents
Digital Content
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
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
38
PharmaCompass offers a list of Olopatadine 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 Olopatadine Hydrochloride manufacturer or Olopatadine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Olopatadine Hydrochloride manufacturer or Olopatadine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Olopatadine Hydrochloride API Price utilized in the formulation of products. Olopatadine Hydrochloride API Price is not always fixed or binding as the Olopatadine Hydrochloride Price is obtained through a variety of data sources. The Olopatadine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Olopatadine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Olopatadine HCl, including repackagers and relabelers. The FDA regulates Olopatadine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Olopatadine HCl API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Olopatadine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Olopatadine HCl supplier is an individual or a company that provides Olopatadine HCl active pharmaceutical ingredient (API) or Olopatadine HCl finished formulations upon request. The Olopatadine HCl suppliers may include Olopatadine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Olopatadine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Olopatadine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Olopatadine HCl active pharmaceutical ingredient (API) in detail. Different forms of Olopatadine HCl DMFs exist exist since differing nations have different regulations, such as Olopatadine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Olopatadine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Olopatadine HCl USDMF includes data on Olopatadine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Olopatadine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Olopatadine HCl suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Olopatadine HCl Drug Master File in Japan (Olopatadine HCl JDMF) empowers Olopatadine HCl API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Olopatadine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Olopatadine HCl JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Olopatadine HCl suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Olopatadine HCl Drug Master File in Korea (Olopatadine HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Olopatadine HCl. The MFDS reviews the Olopatadine HCl KDMF as part of the drug registration process and uses the information provided in the Olopatadine HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Olopatadine HCl KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Olopatadine HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Olopatadine HCl suppliers with KDMF on PharmaCompass.
A Olopatadine HCl written confirmation (Olopatadine HCl WC) is an official document issued by a regulatory agency to a Olopatadine HCl manufacturer, verifying that the manufacturing facility of a Olopatadine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Olopatadine HCl APIs or Olopatadine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Olopatadine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Olopatadine HCl suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Olopatadine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Olopatadine HCl API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Olopatadine HCl as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Olopatadine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Olopatadine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Olopatadine HCl suppliers with NDC on PharmaCompass.
Olopatadine HCl Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Olopatadine HCl GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Olopatadine HCl GMP manufacturer or Olopatadine HCl GMP API supplier for your needs.
A Olopatadine HCl CoA (Certificate of Analysis) is a formal document that attests to Olopatadine HCl's compliance with Olopatadine HCl specifications and serves as a tool for batch-level quality control.
Olopatadine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Olopatadine HCl CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Olopatadine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Olopatadine HCl EP), Olopatadine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Olopatadine HCl USP).
