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1. 4-(diethylamino)-2-butynyl-alpha-cyclohexyl-alpha-hydroxybenzeneacetate
2. 4-(diethylamino)-2-butynyl-alpha-phenylcyclohexaneglycolate
3. Apo-oxybutynin
4. Contimin
5. Cystonorm
6. Cystrin
7. Ditropan
8. Dresplan
9. Dridase
10. Driptane
11. Gelnique
12. Gen-oxybutynin
13. Novo-oxybutynin
14. Nu-oxybutyn
15. Oxyb Abz
16. Oxybugamma
17. Oxybutin Holsten
18. Oxybuton
19. Oxybutynin
20. Oxybutynin Al
21. Oxybutynin Azu
22. Oxybutynin Heumann
23. Oxybutynin Hexal
24. Oxybutynin Hydrochloride
25. Oxybutynin Stada
26. Oxybutynin Von Ct
27. Oxybutynin-puren
28. Oxybutynin-ratiopharm
29. Oxymedin
30. Oxytrol
31. Pms-oxybutynin
32. Pollakisu
33. Renamel
34. Ryol
35. Spasmex Oxybutynin
36. Spasyt
37. Tavor
38. Zatur
1. Oxybutynin Hydrochloride
2. 1508-65-2
3. Oxybutynin Hcl
4. Tropax
5. Oxybutynin (chloride)
6. Ditropan Xl
7. Pollakisu
8. Mj 4309-1
9. L9f3d9renq
10. Nsc-759108
11. Alpha-phenylcyclohexaneglycolic Acid 4-(diethylamino)-2-butynyl Ester Hydrochloride
12. Mls000069688
13. 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride
14. Dridase
15. Smr000058490
16. Mj-4309-1
17. 4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate;hydrochloride
18. Oxybutynin Hydrochloride (jan)
19. 4-diethylamino-2-butynyl Phenyl(cyclohexyl)glycolate Hydrochloride
20. 4-(diethylamino)-2-butynyl Alpha-phenylcyclohexaneglycolate Hydrochloride
21. Gelnique
22. Oxibutinina Hydrochloride
23. Oxybutynin Hydrochloride [jan]
24. Chebi:7857
25. 4-diethylaminobut-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylethanoate Hydrochloride
26. Oxybutynin Chloride [usan]
27. Oxybutyninhydrochloride
28. Sr-01000000184
29. Einecs 216-139-7
30. Unii-l9f3d9renq
31. 4-(diethylamino)but-2-ynyl Cyclohexylphenylglycolate Hydrochloride
32. Oxybutynin Chloride [usan:usp]
33. Ditropan (tn)
34. Gelnique (tn)
35. Prestwick_621
36. Mfcd00072150
37. Oxybutynin-d11 Hcl
38. 4-(diethylamino)but-2-yn-1-yl Cyclohexyl(hydroxy)phenylacetate Hydrochloride
39. Opera_id_1330
40. Ncgc00016583-01
41. Oxybutynin (hydrochloride)
42. Oxybutynin Chloride (usp)
43. Cas-1508-65-2
44. Chembl1133
45. Dsstox_cid_25356
46. Dsstox_rid_80822
47. Dsstox_gsid_45356
48. Schembl25751
49. Mls001148211
50. Mls002222232
51. Regid_for_cid_91505
52. Dtxsid3045356
53. Hy-b0267a
54. (s)-4-(diethylamino)but-2-ynyl 2-cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride
55. Hms1568j16
56. Pharmakon1600-01505399
57. (r,s) - Oxybutynin Hydrochloride
58. Oxybutynin Chloride [vandf]
59. Bcp12138
60. Oxybutynin Chloride-(phenyl-[d5])
61. Tox21_110507
62. Tox21_500923
63. Nsc759108
64. Oxybutynin Chloride [usp-rs]
65. Oxybutynin Hydrochloride [mi]
66. S3117
67. 4-(diethylamino)-2-butynyl (+-)-alpha-phenylcyclohexaneglycolate Hydrochloride
68. Akos015895349
69. Ccg-213420
70. H33o205
71. Ks-1377
72. Lp00923
73. Nc00580
74. Nsc 759108
75. Cyclohexaneglycolic Acid, Alpha-phenyl-, 4-(diethylamino)-2-butynyl Ester, Hydrochloride
76. Oxybutynin Hydrochloride [mart.]
77. Ncgc00094234-01
78. Ncgc00094234-02
79. Ncgc00261608-01
80. Oxybutynin Chloride [orange Book]
81. Oxybutynin Hydrochloride [who-dd]
82. Benzeneacetic Acid, Alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl Ester Hydrochloride
83. Benzeneacetic Acid, Alpha-cyclohexyl-alpha-hydroxy-, 4-(diethylamino)-2-butynyl Ester Hydrochloride, (+-)-
84. Bo166187
85. Oxybutynin Chloride [usp Impurity]
86. Oxybutynin Chloride [usp Monograph]
87. Eu-0100923
88. Ft-0603563
89. Ft-0673411
90. Ft-0673412
91. O0451
92. Oxybutynin Chloride, >=98% (tlc), Powder
93. Sw196787-4
94. A51042
95. D00722
96. O 2881
97. Oxybutynin Hydrochloride [ep Monograph]
98. Oxybutynin Hydrochloride [usp Impurity]
99. A809082
100. J-008750
101. Sr-01000000184-2
102. Sr-01000000184-7
103. Q27107600
104. Oxybutynin Chloride, Meets Ep, Usp Testing Specifications
105. Oxybutynin Chloride, United States Pharmacopeia (usp) Reference Standard
106. Oxybutynin Hydrochloride, British Pharmacopoeia (bp) Reference Standard
107. Oxybutynin Hydrochloride, European Pharmacopoeia (ep) Reference Standard
108. 2-cyclohexyl-2-hydroxy-2-phenylacetic Acid 4-(diethylamino)but-2-ynyl Ester Hcl
109. 4-(diethylamino)-2-butynyl (+/-)-,alpha.-phenylcyclohexaneglycolate Hydrochloride
110. 4-(diethylamino)but-2-yn-1-yl 2-cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride
111. 4-diethylamino-2-butynylphenyl(cyclohexyl)glycolatehydrochloride;oxybutynin Hcl
112. Alpha-phenylcyclohexaneglycolic Acid 4-(diethylamino)-2-butynyl Ester, Hydrochloride
113. Benezeneactetic Acid, .alpha.-cyclohexyl-.alpha.-hydroxy-,4-(diethylamino-2-butunyl Ester Hydrochloride,(+/-)-
114. Benzeneacetic Acid, .alpha.-cyclohexyl-.alpha.-hydroxy-, 4-(diethylamino)-2-butynyl Ester Hydrochloride, (+/-)-
Molecular Weight | 393.9 g/mol |
---|---|
Molecular Formula | C22H32ClNO3 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 8 |
Exact Mass | 393.2070716 g/mol |
Monoisotopic Mass | 393.2070716 g/mol |
Topological Polar Surface Area | 49.8 Ų |
Heavy Atom Count | 27 |
Formal Charge | 0 |
Complexity | 490 |
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 8 | |
---|---|
Drug Name | Ditropan xl |
Drug Label | DITROPAN XL (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each DITROPAN XL Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral admini... |
Active Ingredient | Oxybutynin chloride |
Dosage Form | Tablet, extended release |
Route | Oral |
Strength | 5mg; 10mg; 15mg |
Market Status | Prescription |
Company | Janssen Pharms |
2 of 8 | |
---|---|
Drug Name | Gelnique |
PubMed Health | Oxybutynin (By mouth) |
Drug Classes | Urinary Antispasmodic |
Drug Label | Oxybutynin is an antispasmodic, antimuscarinic agent. GELNIQUE (oxybutynin chloride) is a clear and colorless hydroalcoholic gel containing 100 mg oxybutynin chloride per gram of gel. GELNIQUE is available in a 1 gram (1.14 mL) unit dose that contain... |
Active Ingredient | Oxybutynin chloride |
Dosage Form | Gel |
Route | Transdermal |
Strength | 10%(100mg/packet) |
Market Status | Prescription |
Company | Watson Labs |
3 of 8 | |
---|---|
Drug Name | Oxybutynin chloride |
Drug Label | Oxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor... |
Active Ingredient | Oxybutynin chloride |
Dosage Form | Tablet, extended release; Tablet; Syrup |
Route | Oral |
Strength | 15mg; 5mg; 10mg; 5mg/5ml |
Market Status | Prescription |
Company | Vintage Pharms; Impax Pharms; Mylan Pharms; Wockhardt; Silarx; Pharm Assoc; Teva Pharms Usa; Osmotica Pharm; Usl Pharma; Mylan |
4 of 8 | |
---|---|
Drug Name | Oxybutynin chloride |
PubMed Health | Oxybutynin |
Drug Classes | Urinary Antispasmodic |
Drug Label | Oxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor... |
Active Ingredient | Oxybutynin chloride |
Dosage Form | Tablet, extended release |
Route | oral |
Strength | 15 mg. |
Market Status | Prescription |
Company | Mylan Pharms |
5 of 8 | |
---|---|
Drug Name | Ditropan xl |
Drug Label | DITROPAN XL (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each DITROPAN XL Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral admini... |
Active Ingredient | Oxybutynin chloride |
Dosage Form | Tablet, extended release |
Route | Oral |
Strength | 5mg; 10mg; 15mg |
Market Status | Prescription |
Company | Janssen Pharms |
6 of 8 | |
---|---|
Drug Name | Gelnique |
PubMed Health | Oxybutynin (By mouth) |
Drug Classes | Urinary Antispasmodic |
Drug Label | Oxybutynin is an antispasmodic, antimuscarinic agent. GELNIQUE (oxybutynin chloride) is a clear and colorless hydroalcoholic gel containing 100 mg oxybutynin chloride per gram of gel. GELNIQUE is available in a 1 gram (1.14 mL) unit dose that contain... |
Active Ingredient | Oxybutynin chloride |
Dosage Form | Gel |
Route | Transdermal |
Strength | 10%(100mg/packet) |
Market Status | Prescription |
Company | Watson Labs |
7 of 8 | |
---|---|
Drug Name | Oxybutynin chloride |
Drug Label | Oxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor... |
Active Ingredient | Oxybutynin chloride |
Dosage Form | Tablet, extended release; Tablet; Syrup |
Route | Oral |
Strength | 15mg; 5mg; 10mg; 5mg/5ml |
Market Status | Prescription |
Company | Vintage Pharms; Impax Pharms; Mylan Pharms; Wockhardt; Silarx; Pharm Assoc; Teva Pharms Usa; Osmotica Pharm; Usl Pharma; Mylan |
8 of 8 | |
---|---|
Drug Name | Oxybutynin chloride |
PubMed Health | Oxybutynin |
Drug Classes | Urinary Antispasmodic |
Drug Label | Oxybutynin chloride tablets USP are a debossed, very pale blue, round, biconvex, scored tablet containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochlor... |
Active Ingredient | Oxybutynin chloride |
Dosage Form | Tablet, extended release |
Route | oral |
Strength | 15 mg. |
Market Status | Prescription |
Company | Mylan Pharms |
Muscarinic Antagonists
Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)
Parasympatholytics
Agents that inhibit the actions of the parasympathetic nervous system. The major group of drugs used therapeutically for this purpose is the MUSCARINIC ANTAGONISTS. (See all compounds classified as Parasympatholytics.)
Urological Agents
Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12840
Submission : 1998-02-02
Status : Inactive
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Registration Number : 218MF10148
Registrant's Address : 23, rue Bossuet Z. I. de la Vigne aux Loups F-91160 LONGJUMEAU France
Initial Date of Registration : 2006-01-31
Latest Date of Registration : --
NDC Package Code : 49169-1019
Start Marketing Date : 2009-10-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF, BR, CA |
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-09
Pay. Date : 2013-04-30
DMF Number : 6412
Submission : 1986-06-12
Status : Active
Type : II
Certificate Number : CEP 1998-143 - Rev 07
Issue Date : 2024-06-05
Type : Chemical
Substance Number : 1354
Status : Valid
Registration Number : 226MF10078
Registrant's Address : 21 chemin de la Sauvegarde, 21 Ecully Parc CS 33167 69134 Ecully Cedex FRANCE
Initial Date of Registration : 2014-04-02
Latest Date of Registration : --
NDC Package Code : 49169-1019
Start Marketing Date : 2009-10-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF, BR, CA |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 22852
Submission : 2009-06-12
Status : Active
Type : II
Certificate Number : CEP 2022-348 - Rev 01
Issue Date : 2024-12-23
Type : Chemical
Substance Number : 1354
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-07-21
Written Confirmation Number : WC-0045nA2
Address of the Firm :
NDC Package Code : 66064-1005
Start Marketing Date : 2009-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23757
Submission : 2010-04-14
Status : Active
Type : II
Certificate Number : R1-CEP 2003-112 - Rev 03
Issue Date : 2020-10-15
Type : Chemical
Substance Number : 1354
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7214
Submission : 1987-10-29
Status : Active
Type : II
Certificate Number : R1-CEP 2000-108 - Rev 04
Issue Date : 2015-12-10
Type : Chemical
Substance Number : 1354
Status : Valid
Registration Number : 221MF10114
Registrant's Address : Route du Simplon 1,36,CH-1902 Evionnaz,Switzerland
Initial Date of Registration : 2009-06-10
Latest Date of Registration : --
NDC Package Code : 17381-265
Start Marketing Date : 2010-04-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-12
Pay. Date : 2020-06-15
DMF Number : 34336
Submission : 2020-06-26
Status : Active
Type : II
NDC Package Code : 54469-0007
Start Marketing Date : 2021-03-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12309
Submission : 1997-01-09
Status : Active
Type : II
Certificate Number : R1-CEP 2001-200 - Rev 03
Issue Date : 2018-01-29
Type : Chemical
Substance Number : 1354
Status : Valid
NDC Package Code : 61121-0002
Start Marketing Date : 2003-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Ditropan
Dosage Form : TABLET
Dosage Strength : 5 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info : DISCN
Registration Country : USA
Brand Name : GELNIQUE
Dosage Form : GEL;TRANSDERMAL
Dosage Strength : 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2009-01-27
Application Number : 22204
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OXYBUTYNIN CHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 1997-10-31
Application Number : 75079
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OXYBUTYNIN CHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 2020-12-17
Application Number : 208165
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 2.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : OXYBUTYNIN CHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2016-05-27
Application Number : 206121
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OXYBUTYNIN CHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date : 1988-03-10
Application Number : 70746
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : OXYBUTYNIN CHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 15MG
Packaging :
Approval Date : 2017-06-26
Application Number : 202332
Regulatory Info : RX
Registration Country : USA
DRUG PRODUCT COMPOSITIONS
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Excipients by Applications
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Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
A Oxybutynin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxybutynin Hydrochloride, including repackagers and relabelers. The FDA regulates Oxybutynin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxybutynin Hydrochloride supplier is an individual or a company that provides Oxybutynin Hydrochloride active pharmaceutical ingredient (API) or Oxybutynin Hydrochloride finished formulations upon request. The Oxybutynin Hydrochloride suppliers may include Oxybutynin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Oxybutynin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxybutynin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxybutynin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Oxybutynin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Oxybutynin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxybutynin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Oxybutynin Hydrochloride USDMF includes data on Oxybutynin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxybutynin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride Drug Master File in Japan (Oxybutynin Hydrochloride JDMF) empowers Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride Drug Master File in Korea (Oxybutynin Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oxybutynin Hydrochloride. The MFDS reviews the Oxybutynin Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Oxybutynin Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oxybutynin Hydrochloride suppliers with KDMF on PharmaCompass.
A Oxybutynin Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Oxybutynin Hydrochloride Certificate of Suitability (COS). The purpose of a Oxybutynin Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxybutynin Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxybutynin Hydrochloride to their clients by showing that a Oxybutynin Hydrochloride CEP has been issued for it. The manufacturer submits a Oxybutynin Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxybutynin Hydrochloride CEP holder for the record. Additionally, the data presented in the Oxybutynin Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxybutynin Hydrochloride DMF.
A Oxybutynin Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Oxybutynin Hydrochloride written confirmation (Oxybutynin Hydrochloride WC) is an official document issued by a regulatory agency to a Oxybutynin Hydrochloride manufacturer, verifying that the manufacturing facility of a Oxybutynin Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxybutynin Hydrochloride APIs or Oxybutynin Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxybutynin Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxybutynin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxybutynin Hydrochloride suppliers with NDC on PharmaCompass.
Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride 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 Oxybutynin Hydrochloride GMP manufacturer or Oxybutynin Hydrochloride GMP API supplier for your needs.
A Oxybutynin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Oxybutynin Hydrochloride's compliance with Oxybutynin Hydrochloride specifications and serves as a tool for batch-level quality control.
Oxybutynin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Oxybutynin Hydrochloride 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.
Oxybutynin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxybutynin Hydrochloride EP), Oxybutynin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxybutynin Hydrochloride USP).
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