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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Veranova: A CDMO that manages complexity with confidence.
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JDMF
NDC
ROW
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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.
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.
Aspen API. More than just an API™
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
EU-WC
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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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 : 2019-06-04
Pay. Date : 2016-09-08
DMF Number : 29885
Submission : 2016-08-16
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
Aspen API. More than just an API™
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7099
Submission : 1987-08-06
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
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
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
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
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
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Temad- We think of world-class quality.
Date of Issue : 2018-01-09
Valid Till : 2019-01-09
Written Confirmation Number : 665/131411
Address of the Firm : 28th km of Karaj Makhsous Road, Tehran, Iran
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Buprenorphine Hydrochloride Ph Eur/BP/USP
Date of Issue : 2025-02-11
Valid Till : 2027-06-09
Written Confirmation Number : WC-0278
Address of the Firm : Plot No.6406, 6407 & 6411, GIDC Estate, Ankleshwar-393002, Dist- Bharuch
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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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Minakem
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Dosage Form : Capsule
Grade : Oral
Brand Name : Sodium Stearyl Fumarate G...
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength & disintegration.
Pharmacopoeia Ref : USP, EP, ICH, Q7GMP
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate
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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 ZUBSOLV manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ZUBSOLV, including repackagers and relabelers. The FDA regulates ZUBSOLV manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ZUBSOLV 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 ZUBSOLV manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ZUBSOLV supplier is an individual or a company that provides ZUBSOLV active pharmaceutical ingredient (API) or ZUBSOLV finished formulations upon request. The ZUBSOLV suppliers may include ZUBSOLV API manufacturers, exporters, distributors and traders.
click here to find a list of ZUBSOLV suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ZUBSOLV DMF (Drug Master File) is a document detailing the whole manufacturing process of ZUBSOLV active pharmaceutical ingredient (API) in detail. Different forms of ZUBSOLV DMFs exist exist since differing nations have different regulations, such as ZUBSOLV USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ZUBSOLV DMF submitted to regulatory agencies in the US is known as a USDMF. ZUBSOLV USDMF includes data on ZUBSOLV's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ZUBSOLV USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ZUBSOLV 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 ZUBSOLV Drug Master File in Japan (ZUBSOLV JDMF) empowers ZUBSOLV 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 ZUBSOLV JDMF during the approval evaluation for pharmaceutical products. At the time of ZUBSOLV 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 ZUBSOLV suppliers with JDMF on PharmaCompass.
A ZUBSOLV CEP of the European Pharmacopoeia monograph is often referred to as a ZUBSOLV Certificate of Suitability (COS). The purpose of a ZUBSOLV CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ZUBSOLV EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ZUBSOLV to their clients by showing that a ZUBSOLV CEP has been issued for it. The manufacturer submits a ZUBSOLV CEP (COS) as part of the market authorization procedure, and it takes on the role of a ZUBSOLV CEP holder for the record. Additionally, the data presented in the ZUBSOLV CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ZUBSOLV DMF.
A ZUBSOLV CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ZUBSOLV 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 ZUBSOLV suppliers with CEP (COS) on PharmaCompass.
A ZUBSOLV written confirmation (ZUBSOLV WC) is an official document issued by a regulatory agency to a ZUBSOLV manufacturer, verifying that the manufacturing facility of a ZUBSOLV active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ZUBSOLV APIs or ZUBSOLV finished pharmaceutical products to another nation, regulatory agencies frequently require a ZUBSOLV WC (written confirmation) as part of the regulatory process.
click here to find a list of ZUBSOLV 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 ZUBSOLV as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ZUBSOLV 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 ZUBSOLV 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 ZUBSOLV and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ZUBSOLV NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ZUBSOLV suppliers with NDC on PharmaCompass.
ZUBSOLV 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 ZUBSOLV 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 ZUBSOLV GMP manufacturer or ZUBSOLV GMP API supplier for your needs.
A ZUBSOLV CoA (Certificate of Analysis) is a formal document that attests to ZUBSOLV's compliance with ZUBSOLV specifications and serves as a tool for batch-level quality control.
ZUBSOLV CoA mostly includes findings from lab analyses of a specific batch. For each ZUBSOLV 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.
ZUBSOLV may be tested according to a variety of international standards, such as European Pharmacopoeia (ZUBSOLV EP), ZUBSOLV JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ZUBSOLV USP).
