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API SUPPLIERS
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
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USDMF
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Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
Date of Issue : 2023-09-29
Valid Till : 2026-09-28
Written Confirmation Number : WC-0570
Address of the Firm : Plot No. 112, 113, 114, GIDC Estate Gozariya, Mehsana-382825, Gujarat, India
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Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
About the Company : Synnat Pharma is a fast-growing pharmaceutical company focused on the development, identification, production, and distribution of phytochemicals and botanical extracts. Its APIs a...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.
About the Company : Fishfa Biogenics, a division of Fishfa Rubbers Ltd., manufactures and supplies biological APIs. The company operates GLP labs and WHO-GMP-certified facilities, specializing in ferm...
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. Founded by young entrepreneurs and experienced research and manufac...
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Nanjing Well Pharmaceutical
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ABOUT THIS PAGE
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PharmaCompass offers a list of Pimecrolimus API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pimecrolimus manufacturer or Pimecrolimus supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pimecrolimus manufacturer or Pimecrolimus supplier.
A Elidel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elidel, including repackagers and relabelers. The FDA regulates Elidel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elidel 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 Elidel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Elidel supplier is an individual or a company that provides Elidel active pharmaceutical ingredient (API) or Elidel finished formulations upon request. The Elidel suppliers may include Elidel API manufacturers, exporters, distributors and traders.
click here to find a list of Elidel suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Elidel DMF (Drug Master File) is a document detailing the whole manufacturing process of Elidel active pharmaceutical ingredient (API) in detail. Different forms of Elidel DMFs exist exist since differing nations have different regulations, such as Elidel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Elidel DMF submitted to regulatory agencies in the US is known as a USDMF. Elidel USDMF includes data on Elidel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Elidel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Elidel 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 Elidel Drug Master File in Korea (Elidel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Elidel. The MFDS reviews the Elidel KDMF as part of the drug registration process and uses the information provided in the Elidel KDMF to evaluate the safety and efficacy of the drug.
After submitting a Elidel 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 Elidel API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Elidel suppliers with KDMF on PharmaCompass.
A Elidel written confirmation (Elidel WC) is an official document issued by a regulatory agency to a Elidel manufacturer, verifying that the manufacturing facility of a Elidel active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Elidel APIs or Elidel finished pharmaceutical products to another nation, regulatory agencies frequently require a Elidel WC (written confirmation) as part of the regulatory process.
click here to find a list of Elidel suppliers with Written Confirmation (WC) 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 Elidel as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Elidel 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 Elidel 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 Elidel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Elidel NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Elidel suppliers with NDC on PharmaCompass.
Elidel 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 Elidel GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Elidel GMP manufacturer or Elidel GMP API supplier for your needs.
A Elidel CoA (Certificate of Analysis) is a formal document that attests to Elidel's compliance with Elidel specifications and serves as a tool for batch-level quality control.
Elidel CoA mostly includes findings from lab analyses of a specific batch. For each Elidel 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.
Elidel may be tested according to a variety of international standards, such as European Pharmacopoeia (Elidel EP), Elidel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Elidel USP).
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