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KDMF
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Australia
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Veranova: A CDMO that manages complexity with confidence.
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
EU-WC
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
CEP/COS
NDC
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Temad- We think of world-class quality.
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-30
DMF Number : 19109
Submission : 2006-01-12
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-23
DMF Number : 23683
Submission : 2010-04-05
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-04
Pay. Date : 2016-09-08
DMF Number : 29885
Submission : 2016-08-16
Status :
Type : II
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-29
Pay. Date : 2013-02-14
DMF Number : 25507
Submission : 2011-11-15
Status :
Type : II
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2012-10-26
Pay. Date : 2012-12-03
DMF Number : 21060
Submission : 2007-11-12
Status :
Type : II
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-23
Pay. Date : 2024-02-22
DMF Number : 38839
Submission : 2024-02-29
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-30
Pay. Date : 2012-11-13
DMF Number : 16419
Submission : 2003-01-29
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Veranova: A CDMO that manages complexity with confidence.
Certificate Number : R1-CEP 2002-168 - Rev 07
Status : Valid
Issue Date : 2019-09-25
Type : Chemical
Substance Number : 1181
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Certificate Number : R1-CEP 2017-228 - Rev 00
Status : Valid
Issue Date : 2023-01-23
Type : Chemical
Substance Number : 1181
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Certificate Number : R1-CEP 2010-142 - Rev 05
Status : Valid
Issue Date : 2023-08-23
Type : Chemical
Substance Number : 1181
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
Certificate Number : R1-CEP 2007-325 - Rev 01
Status : Valid
Issue Date : 2022-10-14
Type : Chemical
Substance Number : 1181
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
Buprenorphine Hydrochloride, Process II
Certificate Number : CEP 2024-011 - Rev 00
Status : Valid
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 1181
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R1-CEP 2010-291 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-04-11
Type : Chemical
Substance Number : 1181
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : CEP 2004-251 - Rev 06
Status : Valid
Issue Date : 2025-02-10
Type : Chemical
Substance Number : 1181
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Veranova: A CDMO that manages complexity with confidence.
Registration Number : 218MF11027
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2006-12-28
Latest Date of Registration : 2013-11-11
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
Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in developing and manufacturing specialist and complex APIs for pharma and biotech customers, with over 50 years of experience supporting the healthcare...
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
About the Company : Rusan Pharma is a global pharmaceutical company specializing in addiction and pain management, manufacturing APIs and formulations for controlled substances. Its facilities are GMP...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
About the Company : Noramco, founded in 1979, specializes in developing and manufacturing APIs for opioid and non-opioid products. It excels in controlled substance development, offering supply-chain ...
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products with a focus on rapid development and cost-effective production. Its fully equipped research labs, pilot...
Temad- We think of world-class quality.
About the Company : Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Ira...
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
About the Company : Siegfried is a global Contract Development and Manufacturing Organization providing integrated services for pharmaceutical ingredients & finished dosage forms. With 13 production s...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
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API Imports and Exports
Drugs in Development
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DOSAGE - INJECTABLE;INJECTION - EQ 0.3MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18401
DOSAGE - IMPLANT;IMPLANTATION - EQ 80MG BASE/...DOSAGE - IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT
USFDA APPLICATION NUMBER - 204442
DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG...DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE
USFDA APPLICATION NUMBER - 205637
DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG...DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE
USFDA APPLICATION NUMBER - 205637
DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG B...DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE
USFDA APPLICATION NUMBER - 205637
DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0...DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20733
DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2...DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20733
DOSAGE - FILM;BUCCAL - EQ 0.075MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.15MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.3MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.45MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.6MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.75MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.9MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BA...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE
USFDA APPLICATION NUMBER - 22410
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE
USFDA APPLICATION NUMBER - 22410
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE
USFDA APPLICATION NUMBER - 22410
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE
USFDA APPLICATION NUMBER - 22410
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
52
PharmaCompass offers a list of Buprenorphine 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 Buprenorphine Hydrochloride manufacturer or Buprenorphine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Buprenorphine Hydrochloride manufacturer or Buprenorphine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Buprenorphine Hydrochloride API Price utilized in the formulation of products. Buprenorphine Hydrochloride API Price is not always fixed or binding as the Buprenorphine Hydrochloride Price is obtained through a variety of data sources. The Buprenorphine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 6029 M manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 6029 M, including repackagers and relabelers. The FDA regulates 6029 M manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 6029 M 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 6029 M manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 6029 M supplier is an individual or a company that provides 6029 M active pharmaceutical ingredient (API) or 6029 M finished formulations upon request. The 6029 M suppliers may include 6029 M API manufacturers, exporters, distributors and traders.
click here to find a list of 6029 M suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 6029 M DMF (Drug Master File) is a document detailing the whole manufacturing process of 6029 M active pharmaceutical ingredient (API) in detail. Different forms of 6029 M DMFs exist exist since differing nations have different regulations, such as 6029 M USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 6029 M DMF submitted to regulatory agencies in the US is known as a USDMF. 6029 M USDMF includes data on 6029 M's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 6029 M USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 6029 M 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 6029 M Drug Master File in Japan (6029 M JDMF) empowers 6029 M 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 6029 M JDMF during the approval evaluation for pharmaceutical products. At the time of 6029 M 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 6029 M suppliers with JDMF on PharmaCompass.
A 6029 M CEP of the European Pharmacopoeia monograph is often referred to as a 6029 M Certificate of Suitability (COS). The purpose of a 6029 M CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 6029 M EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 6029 M to their clients by showing that a 6029 M CEP has been issued for it. The manufacturer submits a 6029 M CEP (COS) as part of the market authorization procedure, and it takes on the role of a 6029 M CEP holder for the record. Additionally, the data presented in the 6029 M CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 6029 M DMF.
A 6029 M CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 6029 M 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 6029 M suppliers with CEP (COS) on PharmaCompass.
A 6029 M written confirmation (6029 M WC) is an official document issued by a regulatory agency to a 6029 M manufacturer, verifying that the manufacturing facility of a 6029 M active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 6029 M APIs or 6029 M finished pharmaceutical products to another nation, regulatory agencies frequently require a 6029 M WC (written confirmation) as part of the regulatory process.
click here to find a list of 6029 M 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 6029 M as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 6029 M 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 6029 M 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 6029 M and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 6029 M NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 6029 M suppliers with NDC on PharmaCompass.
6029 M 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 6029 M 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 6029 M GMP manufacturer or 6029 M GMP API supplier for your needs.
A 6029 M CoA (Certificate of Analysis) is a formal document that attests to 6029 M's compliance with 6029 M specifications and serves as a tool for batch-level quality control.
6029 M CoA mostly includes findings from lab analyses of a specific batch. For each 6029 M 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.
6029 M may be tested according to a variety of international standards, such as European Pharmacopoeia (6029 M EP), 6029 M JP (Japanese Pharmacopeia) and the US Pharmacopoeia (6029 M USP).
