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API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Direct Compression
Lubricants & Glidants
Co-Processed Excipients
Disintegrants & Superdisintegrants
Controlled & Modified Release
Thickeners and Stabilizers
Granulation
Chewable & Orodispersible Aids
Taste Masking
Coating Systems & Additives
Film Formers & Plasticizers
Emulsifying Agents
Global Sales Information
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Estropipate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estropipate, including repackagers and relabelers. The FDA regulates Estropipate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estropipate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Estropipate supplier is an individual or a company that provides Estropipate active pharmaceutical ingredient (API) or Estropipate finished formulations upon request. The Estropipate suppliers may include Estropipate API manufacturers, exporters, distributors and traders.
click here to find a list of Estropipate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Estropipate DMF (Drug Master File) is a document detailing the whole manufacturing process of Estropipate active pharmaceutical ingredient (API) in detail. Different forms of Estropipate DMFs exist exist since differing nations have different regulations, such as Estropipate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estropipate DMF submitted to regulatory agencies in the US is known as a USDMF. Estropipate USDMF includes data on Estropipate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estropipate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Estropipate suppliers with USDMF 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 Estropipate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Estropipate 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 Estropipate 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 Estropipate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Estropipate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Estropipate suppliers with NDC on PharmaCompass.
Estropipate 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 Estropipate 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 Estropipate GMP manufacturer or Estropipate GMP API supplier for your needs.
A Estropipate CoA (Certificate of Analysis) is a formal document that attests to Estropipate's compliance with Estropipate specifications and serves as a tool for batch-level quality control.
Estropipate CoA mostly includes findings from lab analyses of a specific batch. For each Estropipate 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.
Estropipate may be tested according to a variety of international standards, such as European Pharmacopoeia (Estropipate EP), Estropipate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Estropipate USP).
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