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API SUPPLIERS
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USDMF
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Lanolin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lanolin, including repackagers and relabelers. The FDA regulates Lanolin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lanolin 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 Lanolin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lanolin supplier is an individual or a company that provides Lanolin active pharmaceutical ingredient (API) or Lanolin finished formulations upon request. The Lanolin suppliers may include Lanolin API manufacturers, exporters, distributors and traders.
click here to find a list of Lanolin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lanolin DMF (Drug Master File) is a document detailing the whole manufacturing process of Lanolin active pharmaceutical ingredient (API) in detail. Different forms of Lanolin DMFs exist exist since differing nations have different regulations, such as Lanolin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lanolin DMF submitted to regulatory agencies in the US is known as a USDMF. Lanolin USDMF includes data on Lanolin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lanolin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lanolin suppliers with USDMF on PharmaCompass.
A Lanolin CEP of the European Pharmacopoeia monograph is often referred to as a Lanolin Certificate of Suitability (COS). The purpose of a Lanolin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lanolin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lanolin to their clients by showing that a Lanolin CEP has been issued for it. The manufacturer submits a Lanolin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lanolin CEP holder for the record. Additionally, the data presented in the Lanolin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lanolin DMF.
A Lanolin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lanolin 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 Lanolin suppliers with CEP (COS) on PharmaCompass.
Lanolin 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 Lanolin 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 Lanolin GMP manufacturer or Lanolin GMP API supplier for your needs.
A Lanolin CoA (Certificate of Analysis) is a formal document that attests to Lanolin's compliance with Lanolin specifications and serves as a tool for batch-level quality control.
Lanolin CoA mostly includes findings from lab analyses of a specific batch. For each Lanolin 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.
Lanolin may be tested according to a variety of international standards, such as European Pharmacopoeia (Lanolin EP), Lanolin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lanolin USP).
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