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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
About the Company : With more than 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology comp...
Aspen API. More than just an API.
About the Company : Aspen API is the cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. With quality, compliance, and teamwork at its core, Aspen...
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, ...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...
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DOSAGE - IMPLANT;IMPLANTATION - EQ 3.6MG BASE
USFDA APPLICATION NUMBER - 19726
DOSAGE - IMPLANT;IMPLANTATION - EQ 10.8MG BAS...DOSAGE - IMPLANT;IMPLANTATION - EQ 10.8MG BASE
USFDA APPLICATION NUMBER - 20578
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15 Jul 2020
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30 Nov 2017
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Goserelin Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Goserelin Acetate, including repackagers and relabelers. The FDA regulates Goserelin Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Goserelin Acetate 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 Goserelin Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Goserelin Acetate supplier is an individual or a company that provides Goserelin Acetate active pharmaceutical ingredient (API) or Goserelin Acetate finished formulations upon request. The Goserelin Acetate suppliers may include Goserelin Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Goserelin Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Goserelin Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Goserelin Acetate active pharmaceutical ingredient (API) in detail. Different forms of Goserelin Acetate DMFs exist exist since differing nations have different regulations, such as Goserelin Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Goserelin Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Goserelin Acetate USDMF includes data on Goserelin Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Goserelin Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Goserelin Acetate 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 Goserelin Acetate Drug Master File in Japan (Goserelin Acetate JDMF) empowers Goserelin Acetate 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 Goserelin Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Goserelin Acetate 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 Goserelin Acetate suppliers with JDMF on PharmaCompass.
A Goserelin Acetate CEP of the European Pharmacopoeia monograph is often referred to as a Goserelin Acetate Certificate of Suitability (COS). The purpose of a Goserelin Acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Goserelin Acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Goserelin Acetate to their clients by showing that a Goserelin Acetate CEP has been issued for it. The manufacturer submits a Goserelin Acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Goserelin Acetate CEP holder for the record. Additionally, the data presented in the Goserelin Acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Goserelin Acetate DMF.
A Goserelin Acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Goserelin Acetate 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 Goserelin Acetate 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 Goserelin Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Goserelin Acetate 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 Goserelin Acetate 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 Goserelin Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Goserelin Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Goserelin Acetate suppliers with NDC on PharmaCompass.
Goserelin Acetate 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 Goserelin Acetate 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 Goserelin Acetate GMP manufacturer or Goserelin Acetate GMP API supplier for your needs.
A Goserelin Acetate CoA (Certificate of Analysis) is a formal document that attests to Goserelin Acetate's compliance with Goserelin Acetate specifications and serves as a tool for batch-level quality control.
Goserelin Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Goserelin Acetate 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.
Goserelin Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Goserelin Acetate EP), Goserelin Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Goserelin Acetate USP).
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