Synopsis
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JDMF
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EU WC
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KDMF
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VMF
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Europe
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Australia
US Medicaid
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Annual Reports
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Regulatory FDF Prices
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API
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers


1. Cocaine Muriate
2. Mls001048924
3. Schembl186756
4. Chembl1874133
5. Akos027446592
6. Smr000387112
7. 1089688-45-8
1. Sal De Merck
2. Unii-xh8t8t6wzh
3. Cocaine N-oxide
| Molecular Weight | 339.8 g/mol |
|---|---|
| Molecular Formula | C17H22ClNO4 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 5 |
| Exact Mass | 339.1237359 g/mol |
| Monoisotopic Mass | 339.1237359 g/mol |
| Topological Polar Surface Area | 55.8 Ų |
| Heavy Atom Count | 23 |
| Formal Charge | 0 |
| Complexity | 432 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 4 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Certificate Number : R1-CEP 1996-051 - Rev 05
Issue Date : 2016-12-19
Type : Chemical
Substance Number : 73
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-02-23
Pay. Date : 2018-02-05
DMF Number : 20995
Submission : 2007-11-02
Status : Active
Type : II
NDC Package Code : 0406-1520
Start Marketing Date : 2013-12-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16579
Submission : 2003-05-09
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29120
Submission : 2017-08-04
Status : Inactive
Type : II

NDC Package Code : 49452-2177
Start Marketing Date : 1997-06-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

NDC Package Code : 38779-0723
Start Marketing Date : 2015-07-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : COCAINE HYDROCHLORIDE
Dosage Form : POW
Dosage Strength : 5g
Packaging : 10X1ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Specs: USP
Registration Country : U.S.A
Brand Name :
Dosage Form : Powder
Dosage Strength :
Packaging : Size: 5 Gram Bottle
Approval Date :
Application Number :
Regulatory Info : Specs: USP
Registration Country : U.S.A

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Regulatory Info : RX
Registration Country : USA
Brand Name : NUMBRINO
Dosage Form : SOLUTION;NASAL
Dosage Strength : 4%
Packaging :
Approval Date : 2020-01-10
Application Number : 209575
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : Narcotic (CDSA I)
Registration Country : Canada
Brand Name : PMS-COCAINE HYDROCHLORIDE TOPICAL SOL 4%
Dosage Form : LIQUID
Dosage Strength : 40MG
Packaging : 5 X 5ML
Approval Date :
Application Number :
Regulatory Info : Narcotic (CDSA I)
Registration Country : Canada

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Regulatory Info : Narcotic (CDSA I)
Registration Country : Canada
Brand Name : PMS-COCAINE HYDROCHLORIDE TOPICAL SOL 10%
Dosage Form : LIQUID
Dosage Strength : 100MG
Packaging : 5 X 5ML
Approval Date :
Application Number :
Regulatory Info : Narcotic (CDSA I)
Registration Country : Canada

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Cocaine HCL BP
Dosage Form : PDR
Dosage Strength : 25g
Packaging : 25X1g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Cocaine HCL BP
Dosage Form : PDR
Dosage Strength : 5g
Packaging : 5X1g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

Regulatory Info : RX
Registration Country : USA
Brand Name : GOPRELTO
Dosage Form : SOLUTION;NASAL
Dosage Strength : 4%
Packaging :
Approval Date : 2017-12-14
Application Number : 209963
Regulatory Info : RX
Registration Country : USA

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RLD : Yes
TE Code :
Brand Name : NUMBRINO
Dosage Form : SOLUTION;NASAL
Dosage Strength : 4%
Approval Date : 2020-01-10
Application Number : 209575
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

Brand Name : GOPRELTO
Dosage Form : SOLUTION;NASAL
Dosage Strength : 4%
Approval Date : 2017-12-14
Application Number : 209963
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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Related Excipient Companies
Excipients by Applications
Patents & EXCLUSIVITIES
Patent Expiration Date : 2037-02-07
US Patent Number : 10016407
Drug Substance Claim :
Drug Product Claim :
Application Number : 209575
Patent Use Code : U-2226
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-02-07

Patent Expiration Date : 2037-02-07
US Patent Number : 10231961
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 209575
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-02-07

Patent Expiration Date : 2037-02-07
US Patent Number : 10016407
Drug Substance Claim :
Drug Product Claim :
Application Number : 209575
Patent Use Code : U-2329
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-02-07

Patent Expiration Date : 2037-02-07
US Patent Number : 10894012
Drug Substance Claim :
Drug Product Claim :
Application Number : 209575
Patent Use Code : U-3014
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-02-07

Patent Expiration Date : 2037-02-07
US Patent Number : 9867815
Drug Substance Claim :
Drug Product Claim :
Application Number : 209575
Patent Use Code : U-2225
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-02-07

Patent Expiration Date : 2037-02-07
US Patent Number : 10857095
Drug Substance Claim :
Drug Product Claim :
Application Number : 209575
Patent Use Code : U-3014
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-02-07

Patent Expiration Date : 2037-02-07
US Patent Number : 10149843
Drug Substance Claim :
Drug Product Claim :
Application Number : 209963
Patent Use Code : U-2479
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-02-07

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Virtual Booth
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Patent Expiration Date : 2037-02-07
US Patent Number : 10149843
Drug Substance Claim :
Drug Product Claim :
Application Number : 209963
Patent Use Code : U-2478
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-02-07

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Patent Expiration Date : 2037-02-07
US Patent Number : 10016407
Drug Substance Claim :
Drug Product Claim :
Application Number : 209963
Patent Use Code : U-2329
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-02-07

Portfolio PDF
Product Web Link
Virtual Booth
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Website
Corporate PDF
Patent Expiration Date : 2037-02-07
US Patent Number : 11040032
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 209963
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-02-07

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
84
PharmaCompass offers a list of Cocaine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cocaine Hydrochloride manufacturer or Cocaine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cocaine Hydrochloride manufacturer or Cocaine Hydrochloride supplier.
A Cocaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cocaine, including repackagers and relabelers. The FDA regulates Cocaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cocaine 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 Cocaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Cocaine supplier is an individual or a company that provides Cocaine active pharmaceutical ingredient (API) or Cocaine finished formulations upon request. The Cocaine suppliers may include Cocaine API manufacturers, exporters, distributors and traders.
click here to find a list of Cocaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cocaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cocaine active pharmaceutical ingredient (API) in detail. Different forms of Cocaine DMFs exist exist since differing nations have different regulations, such as Cocaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cocaine DMF submitted to regulatory agencies in the US is known as a USDMF. Cocaine USDMF includes data on Cocaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cocaine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cocaine suppliers with USDMF on PharmaCompass.
A Cocaine CEP of the European Pharmacopoeia monograph is often referred to as a Cocaine Certificate of Suitability (COS). The purpose of a Cocaine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cocaine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cocaine to their clients by showing that a Cocaine CEP has been issued for it. The manufacturer submits a Cocaine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cocaine CEP holder for the record. Additionally, the data presented in the Cocaine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cocaine DMF.
A Cocaine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cocaine 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 Cocaine suppliers with CEP (COS) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Cocaine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cocaine 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 Cocaine 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 Cocaine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cocaine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cocaine suppliers with NDC on PharmaCompass.
Cocaine 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 Cocaine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cocaine GMP manufacturer or Cocaine GMP API supplier for your needs.
A Cocaine CoA (Certificate of Analysis) is a formal document that attests to Cocaine's compliance with Cocaine specifications and serves as a tool for batch-level quality control.
Cocaine CoA mostly includes findings from lab analyses of a specific batch. For each Cocaine 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.
Cocaine may be tested according to a variety of international standards, such as European Pharmacopoeia (Cocaine EP), Cocaine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cocaine USP).