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API SUPPLIERS
Neuland Laboratories- A dedicated 100% API provider.
Inke S.A: APIs manufacturing plant.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Chongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.
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NDC API
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Neuland Laboratories- A dedicated 100% API provider.
About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...
Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...
Chongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.
About the Company : Sintaho Pharmaceutical Co., Ltd., located in Chongqing, China, contributes to being the most dependable partner for global pharmaceutical companies. Sintaho specializes in chemosyn...
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A Ensifentrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ensifentrine, including repackagers and relabelers. The FDA regulates Ensifentrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ensifentrine 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 Ensifentrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ensifentrine supplier is an individual or a company that provides Ensifentrine active pharmaceutical ingredient (API) or Ensifentrine finished formulations upon request. The Ensifentrine suppliers may include Ensifentrine API manufacturers, exporters, distributors and traders.
click here to find a list of Ensifentrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Ensifentrine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ensifentrine 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 Ensifentrine 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 Ensifentrine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ensifentrine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ensifentrine suppliers with NDC on PharmaCompass.
Ensifentrine 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 Ensifentrine 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 Ensifentrine GMP manufacturer or Ensifentrine GMP API supplier for your needs.
A Ensifentrine CoA (Certificate of Analysis) is a formal document that attests to Ensifentrine's compliance with Ensifentrine specifications and serves as a tool for batch-level quality control.
Ensifentrine CoA mostly includes findings from lab analyses of a specific batch. For each Ensifentrine 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.
Ensifentrine may be tested according to a variety of international standards, such as European Pharmacopoeia (Ensifentrine EP), Ensifentrine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ensifentrine USP).
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