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JDMF
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API SUPPLIERS
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USDMF
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Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
About the Company : Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.
...
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
About the Company : A research-based international pharmaceutical company, Coral Drugs has more than 27 years of expertise in manufacturing a wide variety of high-quality and affordable active pharmac...
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
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, ...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
INTERMEDIATE SUPPLIERS
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DOSAGE - SUSPENSION;ORAL - 40MG/ML **Federal ...DOSAGE - SUSPENSION;ORAL - 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20264
DOSAGE - SUSPENSION;ORAL - 125MG/ML
USFDA APPLICATION NUMBER - 21778
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EUROAPI
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
15
PharmaCompass offers a list of Megestrol Acetate 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 Megestrol Acetate manufacturer or Megestrol Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Megestrol Acetate manufacturer or Megestrol Acetate supplier.
PharmaCompass also assists you with knowing the Megestrol Acetate API Price utilized in the formulation of products. Megestrol Acetate API Price is not always fixed or binding as the Megestrol Acetate Price is obtained through a variety of data sources. The Megestrol Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Megestat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Megestat, including repackagers and relabelers. The FDA regulates Megestat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Megestat 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 Megestat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Megestat supplier is an individual or a company that provides Megestat active pharmaceutical ingredient (API) or Megestat finished formulations upon request. The Megestat suppliers may include Megestat API manufacturers, exporters, distributors and traders.
click here to find a list of Megestat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Megestat DMF (Drug Master File) is a document detailing the whole manufacturing process of Megestat active pharmaceutical ingredient (API) in detail. Different forms of Megestat DMFs exist exist since differing nations have different regulations, such as Megestat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Megestat DMF submitted to regulatory agencies in the US is known as a USDMF. Megestat USDMF includes data on Megestat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Megestat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Megestat suppliers with USDMF 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 Megestat Drug Master File in Korea (Megestat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Megestat. The MFDS reviews the Megestat KDMF as part of the drug registration process and uses the information provided in the Megestat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Megestat 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 Megestat API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Megestat suppliers with KDMF on PharmaCompass.
A Megestat CEP of the European Pharmacopoeia monograph is often referred to as a Megestat Certificate of Suitability (COS). The purpose of a Megestat CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Megestat EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Megestat to their clients by showing that a Megestat CEP has been issued for it. The manufacturer submits a Megestat CEP (COS) as part of the market authorization procedure, and it takes on the role of a Megestat CEP holder for the record. Additionally, the data presented in the Megestat CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Megestat DMF.
A Megestat CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Megestat 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 Megestat 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 Megestat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Megestat 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 Megestat 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 Megestat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Megestat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Megestat suppliers with NDC on PharmaCompass.
Megestat 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 Megestat 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 Megestat GMP manufacturer or Megestat GMP API supplier for your needs.
A Megestat CoA (Certificate of Analysis) is a formal document that attests to Megestat's compliance with Megestat specifications and serves as a tool for batch-level quality control.
Megestat CoA mostly includes findings from lab analyses of a specific batch. For each Megestat 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.
Megestat may be tested according to a variety of international standards, such as European Pharmacopoeia (Megestat EP), Megestat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Megestat USP).
