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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-06
Pay. Date : 2014-05-28
DMF Number : 19846
Submission : 2006-10-06
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-06
Pay. Date : 2012-11-23
DMF Number : 19561
Submission : 2006-06-29
Status :
Type : II
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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- TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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ABOUT THIS PAGE
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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 Hydromorphon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydromorphon, including repackagers and relabelers. The FDA regulates Hydromorphon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydromorphon 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 Hydromorphon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydromorphon supplier is an individual or a company that provides Hydromorphon active pharmaceutical ingredient (API) or Hydromorphon finished formulations upon request. The Hydromorphon suppliers may include Hydromorphon API manufacturers, exporters, distributors and traders.
click here to find a list of Hydromorphon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydromorphon DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydromorphon active pharmaceutical ingredient (API) in detail. Different forms of Hydromorphon DMFs exist exist since differing nations have different regulations, such as Hydromorphon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydromorphon DMF submitted to regulatory agencies in the US is known as a USDMF. Hydromorphon USDMF includes data on Hydromorphon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydromorphon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydromorphon 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 Hydromorphon Drug Master File in Japan (Hydromorphon JDMF) empowers Hydromorphon 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 Hydromorphon JDMF during the approval evaluation for pharmaceutical products. At the time of Hydromorphon 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 Hydromorphon 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 Hydromorphon Drug Master File in Korea (Hydromorphon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hydromorphon. The MFDS reviews the Hydromorphon KDMF as part of the drug registration process and uses the information provided in the Hydromorphon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hydromorphon 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 Hydromorphon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hydromorphon suppliers with KDMF on PharmaCompass.
A Hydromorphon CEP of the European Pharmacopoeia monograph is often referred to as a Hydromorphon Certificate of Suitability (COS). The purpose of a Hydromorphon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydromorphon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydromorphon to their clients by showing that a Hydromorphon CEP has been issued for it. The manufacturer submits a Hydromorphon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydromorphon CEP holder for the record. Additionally, the data presented in the Hydromorphon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydromorphon DMF.
A Hydromorphon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydromorphon 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 Hydromorphon 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 Hydromorphon as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydromorphon 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 Hydromorphon 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 Hydromorphon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydromorphon NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydromorphon suppliers with NDC on PharmaCompass.
Hydromorphon 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 Hydromorphon 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 Hydromorphon GMP manufacturer or Hydromorphon GMP API supplier for your needs.
A Hydromorphon CoA (Certificate of Analysis) is a formal document that attests to Hydromorphon's compliance with Hydromorphon specifications and serves as a tool for batch-level quality control.
Hydromorphon CoA mostly includes findings from lab analyses of a specific batch. For each Hydromorphon 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.
Hydromorphon may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydromorphon EP), Hydromorphon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydromorphon USP).
