Synopsis
0
EU WC
0
VMF
DRUG PRODUCT COMPOSITIONS0
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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
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]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - 0.2MG/ML
USFDA APPLICATION NUMBER - 19034
DOSAGE - INJECTABLE;INJECTION - 0.5MG/0.5ML
USFDA APPLICATION NUMBER - 19034
DOSAGE - INJECTABLE;INJECTION - 10MG/ML
USFDA APPLICATION NUMBER - 19034
DOSAGE - INJECTABLE;INJECTION - 1MG/ML
USFDA APPLICATION NUMBER - 19034
DOSAGE - INJECTABLE;INJECTION - 2MG/ML
USFDA APPLICATION NUMBER - 19034
DOSAGE - INJECTABLE;INJECTION - 4MG/ML
USFDA APPLICATION NUMBER - 19034
DOSAGE - SOLUTION;ORAL - 5MG/5ML
USFDA APPLICATION NUMBER - 19891
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 19892
DOSAGE - TABLET;ORAL - 4MG
USFDA APPLICATION NUMBER - 19892
DOSAGE - TABLET;ORAL - 8MG
USFDA APPLICATION NUMBER - 19892
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21217
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21217
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 32MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21217
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21217
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Huzhou Sunflower Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vertellus
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Controlled & Modified Release
Direct Compression
Solubilizers
Film Formers & Plasticizers
Parenteral
Thickeners and Stabilizers
Granulation
Co-Processed Excipients
Disintegrants & Superdisintegrants
Topical
Taste Masking
Lubricants & Glidants
Chewable & Orodispersible Aids
Emulsifying Agents
API Stability Enhancers
Rheology Modifiers
Empty Capsules
Coloring Agents
Vegetarian Capsules
Surfactant & Foaming Agents
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
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
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
45
PharmaCompass offers a list of Hydromorphone 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 Hydromorphone Hydrochloride manufacturer or Hydromorphone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydromorphone Hydrochloride manufacturer or Hydromorphone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Hydromorphone Hydrochloride API Price utilized in the formulation of products. Hydromorphone Hydrochloride API Price is not always fixed or binding as the Hydromorphone Hydrochloride Price is obtained through a variety of data sources. The Hydromorphone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dihydromorphinone HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dihydromorphinone HCl, including repackagers and relabelers. The FDA regulates Dihydromorphinone HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dihydromorphinone HCl 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 Dihydromorphinone HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dihydromorphinone HCl supplier is an individual or a company that provides Dihydromorphinone HCl active pharmaceutical ingredient (API) or Dihydromorphinone HCl finished formulations upon request. The Dihydromorphinone HCl suppliers may include Dihydromorphinone HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Dihydromorphinone HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dihydromorphinone HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Dihydromorphinone HCl active pharmaceutical ingredient (API) in detail. Different forms of Dihydromorphinone HCl DMFs exist exist since differing nations have different regulations, such as Dihydromorphinone HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dihydromorphinone HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Dihydromorphinone HCl USDMF includes data on Dihydromorphinone HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dihydromorphinone HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dihydromorphinone HCl 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 Dihydromorphinone HCl Drug Master File in Japan (Dihydromorphinone HCl JDMF) empowers Dihydromorphinone HCl 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 Dihydromorphinone HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Dihydromorphinone HCl 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 Dihydromorphinone HCl 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 Dihydromorphinone HCl Drug Master File in Korea (Dihydromorphinone HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dihydromorphinone HCl. The MFDS reviews the Dihydromorphinone HCl KDMF as part of the drug registration process and uses the information provided in the Dihydromorphinone HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dihydromorphinone HCl 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 Dihydromorphinone HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dihydromorphinone HCl suppliers with KDMF on PharmaCompass.
A Dihydromorphinone HCl CEP of the European Pharmacopoeia monograph is often referred to as a Dihydromorphinone HCl Certificate of Suitability (COS). The purpose of a Dihydromorphinone HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dihydromorphinone HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dihydromorphinone HCl to their clients by showing that a Dihydromorphinone HCl CEP has been issued for it. The manufacturer submits a Dihydromorphinone HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dihydromorphinone HCl CEP holder for the record. Additionally, the data presented in the Dihydromorphinone HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dihydromorphinone HCl DMF.
A Dihydromorphinone HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dihydromorphinone HCl 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 Dihydromorphinone HCl 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 Dihydromorphinone HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dihydromorphinone HCl 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 Dihydromorphinone HCl 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 Dihydromorphinone HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dihydromorphinone HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dihydromorphinone HCl suppliers with NDC on PharmaCompass.
Dihydromorphinone HCl 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 Dihydromorphinone HCl 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 Dihydromorphinone HCl GMP manufacturer or Dihydromorphinone HCl GMP API supplier for your needs.
A Dihydromorphinone HCl CoA (Certificate of Analysis) is a formal document that attests to Dihydromorphinone HCl's compliance with Dihydromorphinone HCl specifications and serves as a tool for batch-level quality control.
Dihydromorphinone HCl CoA mostly includes findings from lab analyses of a specific batch. For each Dihydromorphinone HCl 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.
Dihydromorphinone HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Dihydromorphinone HCl EP), Dihydromorphinone HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dihydromorphinone HCl USP).
