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API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
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USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36707
Submission : 2022-06-01
Status :
Type : II
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
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...
Mesochem is focused on incessant innovation along with the R&D of new APIs.
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Spinosyn D 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 Spinosyn D manufacturer or Spinosyn D supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Spinosyn D manufacturer or Spinosyn D supplier.
PharmaCompass also assists you with knowing the Spinosyn D API Price utilized in the formulation of products. Spinosyn D API Price is not always fixed or binding as the Spinosyn D Price is obtained through a variety of data sources. The Spinosyn D Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Spinosad manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spinosad, including repackagers and relabelers. The FDA regulates Spinosad manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spinosad 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 Spinosad manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Spinosad supplier is an individual or a company that provides Spinosad active pharmaceutical ingredient (API) or Spinosad finished formulations upon request. The Spinosad suppliers may include Spinosad API manufacturers, exporters, distributors and traders.
click here to find a list of Spinosad suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Spinosad DMF (Drug Master File) is a document detailing the whole manufacturing process of Spinosad active pharmaceutical ingredient (API) in detail. Different forms of Spinosad DMFs exist exist since differing nations have different regulations, such as Spinosad USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Spinosad DMF submitted to regulatory agencies in the US is known as a USDMF. Spinosad USDMF includes data on Spinosad's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Spinosad USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Spinosad 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 Spinosad as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Spinosad 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 Spinosad 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 Spinosad and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Spinosad NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Spinosad suppliers with NDC on PharmaCompass.
Spinosad 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 Spinosad 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 Spinosad GMP manufacturer or Spinosad GMP API supplier for your needs.
A Spinosad CoA (Certificate of Analysis) is a formal document that attests to Spinosad's compliance with Spinosad specifications and serves as a tool for batch-level quality control.
Spinosad CoA mostly includes findings from lab analyses of a specific batch. For each Spinosad 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.
Spinosad may be tested according to a variety of international standards, such as European Pharmacopoeia (Spinosad EP), Spinosad JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Spinosad USP).
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