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API SUPPLIERS
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USDMF
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0218n
Address of the Firm : A-5/2, Late Parshuram Industrial Area, MIDC, Tal-Khed, Dist. Ratnagiri-415 722, ...
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited is a globally recognized, technology-driven manufacturer of APIs , CDMO & formulations, established in 1987. Headquartered in Mumbai, India, we operate ...
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
About the Company : Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty Fine Chemicals. Our c...
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APIs
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17 Nov 2018
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Nicorandil 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 Nicorandil manufacturer or Nicorandil supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nicorandil manufacturer or Nicorandil supplier.
PharmaCompass also assists you with knowing the Nicorandil API Price utilized in the formulation of products. Nicorandil API Price is not always fixed or binding as the Nicorandil Price is obtained through a variety of data sources. The Nicorandil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ZYNICOR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ZYNICOR, including repackagers and relabelers. The FDA regulates ZYNICOR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ZYNICOR 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 ZYNICOR manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ZYNICOR supplier is an individual or a company that provides ZYNICOR active pharmaceutical ingredient (API) or ZYNICOR finished formulations upon request. The ZYNICOR suppliers may include ZYNICOR API manufacturers, exporters, distributors and traders.
click here to find a list of ZYNICOR suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ZYNICOR DMF (Drug Master File) is a document detailing the whole manufacturing process of ZYNICOR active pharmaceutical ingredient (API) in detail. Different forms of ZYNICOR DMFs exist exist since differing nations have different regulations, such as ZYNICOR USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ZYNICOR DMF submitted to regulatory agencies in the US is known as a USDMF. ZYNICOR USDMF includes data on ZYNICOR's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ZYNICOR USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ZYNICOR suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The ZYNICOR Drug Master File in Japan (ZYNICOR JDMF) empowers ZYNICOR API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the ZYNICOR JDMF during the approval evaluation for pharmaceutical products. At the time of ZYNICOR JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of ZYNICOR suppliers with JDMF 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 ZYNICOR Drug Master File in Korea (ZYNICOR KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ZYNICOR. The MFDS reviews the ZYNICOR KDMF as part of the drug registration process and uses the information provided in the ZYNICOR KDMF to evaluate the safety and efficacy of the drug.
After submitting a ZYNICOR 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 ZYNICOR API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ZYNICOR suppliers with KDMF on PharmaCompass.
A ZYNICOR CEP of the European Pharmacopoeia monograph is often referred to as a ZYNICOR Certificate of Suitability (COS). The purpose of a ZYNICOR CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ZYNICOR EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ZYNICOR to their clients by showing that a ZYNICOR CEP has been issued for it. The manufacturer submits a ZYNICOR CEP (COS) as part of the market authorization procedure, and it takes on the role of a ZYNICOR CEP holder for the record. Additionally, the data presented in the ZYNICOR CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ZYNICOR DMF.
A ZYNICOR CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ZYNICOR 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 ZYNICOR suppliers with CEP (COS) on PharmaCompass.
A ZYNICOR written confirmation (ZYNICOR WC) is an official document issued by a regulatory agency to a ZYNICOR manufacturer, verifying that the manufacturing facility of a ZYNICOR active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ZYNICOR APIs or ZYNICOR finished pharmaceutical products to another nation, regulatory agencies frequently require a ZYNICOR WC (written confirmation) as part of the regulatory process.
click here to find a list of ZYNICOR suppliers with Written Confirmation (WC) on PharmaCompass.
ZYNICOR 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 ZYNICOR 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 ZYNICOR GMP manufacturer or ZYNICOR GMP API supplier for your needs.
A ZYNICOR CoA (Certificate of Analysis) is a formal document that attests to ZYNICOR's compliance with ZYNICOR specifications and serves as a tool for batch-level quality control.
ZYNICOR CoA mostly includes findings from lab analyses of a specific batch. For each ZYNICOR 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.
ZYNICOR may be tested according to a variety of international standards, such as European Pharmacopoeia (ZYNICOR EP), ZYNICOR JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ZYNICOR USP).
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