Synopsis
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EU WC
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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Veranova: A CDMO that manages complexity with confidence.
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NDC
KDMF
ROW
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
CEP/COS
NDC
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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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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Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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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
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ABOUT THIS PAGE
A Hydromorphone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydromorphone Hydrochloride, including repackagers and relabelers. The FDA regulates Hydromorphone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydromorphone Hydrochloride supplier is an individual or a company that provides Hydromorphone Hydrochloride active pharmaceutical ingredient (API) or Hydromorphone Hydrochloride finished formulations upon request. The Hydromorphone Hydrochloride suppliers may include Hydromorphone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Hydromorphone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydromorphone Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydromorphone Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Hydromorphone Hydrochloride DMFs exist exist since differing nations have different regulations, such as Hydromorphone Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydromorphone Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Hydromorphone Hydrochloride USDMF includes data on Hydromorphone Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydromorphone Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride Drug Master File in Japan (Hydromorphone Hydrochloride JDMF) empowers Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride Drug Master File in Korea (Hydromorphone Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hydromorphone Hydrochloride. The MFDS reviews the Hydromorphone Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Hydromorphone Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hydromorphone Hydrochloride suppliers with KDMF on PharmaCompass.
A Hydromorphone Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Hydromorphone Hydrochloride Certificate of Suitability (COS). The purpose of a Hydromorphone Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydromorphone Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydromorphone Hydrochloride to their clients by showing that a Hydromorphone Hydrochloride CEP has been issued for it. The manufacturer submits a Hydromorphone Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydromorphone Hydrochloride CEP holder for the record. Additionally, the data presented in the Hydromorphone Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydromorphone Hydrochloride DMF.
A Hydromorphone Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydromorphone Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydromorphone Hydrochloride suppliers with NDC on PharmaCompass.
Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride GMP manufacturer or Hydromorphone Hydrochloride GMP API supplier for your needs.
A Hydromorphone Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Hydromorphone Hydrochloride's compliance with Hydromorphone Hydrochloride specifications and serves as a tool for batch-level quality control.
Hydromorphone Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Hydromorphone Hydrochloride 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.
Hydromorphone Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydromorphone Hydrochloride EP), Hydromorphone Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydromorphone Hydrochloride USP).
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