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- TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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