Synopsis
0
CEP/COS
0
JDMF
0
KDMF
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-23
Pay. Date : 2013-11-15
DMF Number : 21144
Submission : 2007-06-20
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
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
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Nalbuphine Hydrochloride Monohydrate IH
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
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
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...
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...
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
About the Company : Deccan Nutraceuticals Pvt. Ltd. (DNPL) is a group company of Alkaloids Corporation (India), was founded in 2001 and operates from a 22,000 sq. m. facility in Pune (India). Their co...
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...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
About the Company : As an internationally renowned outsourcing partner, we offer products and tailor-made service packages that are seamlessly embedded in the value chain of our customers. Our pharmac...
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
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]Related Excipient Companies
Parenteral
Controlled & Modified Release
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
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
70
PharmaCompass offers a list of Nalbuphine 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 Nalbuphine Hydrochloride manufacturer or Nalbuphine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nalbuphine Hydrochloride manufacturer or Nalbuphine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Nalbuphine Hydrochloride API Price utilized in the formulation of products. Nalbuphine Hydrochloride API Price is not always fixed or binding as the Nalbuphine Hydrochloride Price is obtained through a variety of data sources. The Nalbuphine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nubain manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nubain, including repackagers and relabelers. The FDA regulates Nubain manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nubain 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 Nubain manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nubain supplier is an individual or a company that provides Nubain active pharmaceutical ingredient (API) or Nubain finished formulations upon request. The Nubain suppliers may include Nubain API manufacturers, exporters, distributors and traders.
click here to find a list of Nubain suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nubain DMF (Drug Master File) is a document detailing the whole manufacturing process of Nubain active pharmaceutical ingredient (API) in detail. Different forms of Nubain DMFs exist exist since differing nations have different regulations, such as Nubain USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nubain DMF submitted to regulatory agencies in the US is known as a USDMF. Nubain USDMF includes data on Nubain's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nubain USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nubain suppliers with USDMF on PharmaCompass.
A Nubain written confirmation (Nubain WC) is an official document issued by a regulatory agency to a Nubain manufacturer, verifying that the manufacturing facility of a Nubain active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nubain APIs or Nubain finished pharmaceutical products to another nation, regulatory agencies frequently require a Nubain WC (written confirmation) as part of the regulatory process.
click here to find a list of Nubain 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 Nubain as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nubain 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 Nubain 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 Nubain and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nubain NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nubain suppliers with NDC on PharmaCompass.
Nubain 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 Nubain 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 Nubain GMP manufacturer or Nubain GMP API supplier for your needs.
A Nubain CoA (Certificate of Analysis) is a formal document that attests to Nubain's compliance with Nubain specifications and serves as a tool for batch-level quality control.
Nubain CoA mostly includes findings from lab analyses of a specific batch. For each Nubain 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.
Nubain may be tested according to a variety of international standards, such as European Pharmacopoeia (Nubain EP), Nubain JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nubain USP).
