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API SUPPLIERS
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USDMF
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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...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Temad- We think of world-class quality.
About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
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...
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...
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...
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DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG...DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE
USFDA APPLICATION NUMBER - 205637
DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG...DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE
USFDA APPLICATION NUMBER - 205637
DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG B...DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE
USFDA APPLICATION NUMBER - 205637
DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS...DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML)
USFDA APPLICATION NUMBER - 205787
DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0...DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20733
DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2...DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20733
DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS...DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML)
USFDA APPLICATION NUMBER - 209862
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BA...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE
USFDA APPLICATION NUMBER - 22410
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE
USFDA APPLICATION NUMBER - 22410
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE
USFDA APPLICATION NUMBER - 22410
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE
USFDA APPLICATION NUMBER - 22410
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PharmaCompass offers a list of Naloxone 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 Naloxone Hydrochloride manufacturer or Naloxone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Naloxone Hydrochloride manufacturer or Naloxone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Naloxone Hydrochloride API Price utilized in the formulation of products. Naloxone Hydrochloride API Price is not always fixed or binding as the Naloxone Hydrochloride Price is obtained through a variety of data sources. The Naloxone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Naloxone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naloxone Hydrochloride, including repackagers and relabelers. The FDA regulates Naloxone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naloxone 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 Naloxone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naloxone Hydrochloride supplier is an individual or a company that provides Naloxone Hydrochloride active pharmaceutical ingredient (API) or Naloxone Hydrochloride finished formulations upon request. The Naloxone Hydrochloride suppliers may include Naloxone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Naloxone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Naloxone Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Naloxone Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Naloxone Hydrochloride DMFs exist exist since differing nations have different regulations, such as Naloxone Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naloxone Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Naloxone Hydrochloride USDMF includes data on Naloxone Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naloxone Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naloxone 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 Naloxone Hydrochloride Drug Master File in Japan (Naloxone Hydrochloride JDMF) empowers Naloxone 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 Naloxone Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Naloxone 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 Naloxone 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 Naloxone Hydrochloride Drug Master File in Korea (Naloxone Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naloxone Hydrochloride. The MFDS reviews the Naloxone Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Naloxone Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Naloxone 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 Naloxone Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Naloxone Hydrochloride suppliers with KDMF on PharmaCompass.
A Naloxone Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Naloxone Hydrochloride Certificate of Suitability (COS). The purpose of a Naloxone Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Naloxone Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Naloxone Hydrochloride to their clients by showing that a Naloxone Hydrochloride CEP has been issued for it. The manufacturer submits a Naloxone Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Naloxone Hydrochloride CEP holder for the record. Additionally, the data presented in the Naloxone Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Naloxone Hydrochloride DMF.
A Naloxone Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Naloxone 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 Naloxone Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Naloxone Hydrochloride written confirmation (Naloxone Hydrochloride WC) is an official document issued by a regulatory agency to a Naloxone Hydrochloride manufacturer, verifying that the manufacturing facility of a Naloxone Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naloxone Hydrochloride APIs or Naloxone Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Naloxone Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Naloxone Hydrochloride 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 Naloxone Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Naloxone 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 Naloxone 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 Naloxone Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naloxone Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Naloxone Hydrochloride suppliers with NDC on PharmaCompass.
Naloxone 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 Naloxone 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 Naloxone Hydrochloride GMP manufacturer or Naloxone Hydrochloride GMP API supplier for your needs.
A Naloxone Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Naloxone Hydrochloride's compliance with Naloxone Hydrochloride specifications and serves as a tool for batch-level quality control.
Naloxone Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Naloxone 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.
Naloxone Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Naloxone Hydrochloride EP), Naloxone Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naloxone Hydrochloride USP).
