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API SUPPLIERS
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Vital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins
EU-WC
KDMF
TW, MX 
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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USDMF
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35670
Submission : 2021-03-31
Status :
Type : II
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Methylcobalamin 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 Methylcobalamin manufacturer or Methylcobalamin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methylcobalamin manufacturer or Methylcobalamin supplier.
A Mecobalamin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mecobalamin, including repackagers and relabelers. The FDA regulates Mecobalamin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mecobalamin 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 Mecobalamin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Mecobalamin supplier is an individual or a company that provides Mecobalamin active pharmaceutical ingredient (API) or Mecobalamin finished formulations upon request. The Mecobalamin suppliers may include Mecobalamin API manufacturers, exporters, distributors and traders.
click here to find a list of Mecobalamin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Mecobalamin DMF (Drug Master File) is a document detailing the whole manufacturing process of Mecobalamin active pharmaceutical ingredient (API) in detail. Different forms of Mecobalamin DMFs exist exist since differing nations have different regulations, such as Mecobalamin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mecobalamin DMF submitted to regulatory agencies in the US is known as a USDMF. Mecobalamin USDMF includes data on Mecobalamin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mecobalamin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mecobalamin 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 Mecobalamin Drug Master File in Japan (Mecobalamin JDMF) empowers Mecobalamin 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 Mecobalamin JDMF during the approval evaluation for pharmaceutical products. At the time of Mecobalamin 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 Mecobalamin 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 Mecobalamin Drug Master File in Korea (Mecobalamin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mecobalamin. The MFDS reviews the Mecobalamin KDMF as part of the drug registration process and uses the information provided in the Mecobalamin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mecobalamin 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 Mecobalamin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mecobalamin suppliers with KDMF on PharmaCompass.
A Mecobalamin written confirmation (Mecobalamin WC) is an official document issued by a regulatory agency to a Mecobalamin manufacturer, verifying that the manufacturing facility of a Mecobalamin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mecobalamin APIs or Mecobalamin finished pharmaceutical products to another nation, regulatory agencies frequently require a Mecobalamin WC (written confirmation) as part of the regulatory process.
click here to find a list of Mecobalamin 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 Mecobalamin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mecobalamin 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 Mecobalamin 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 Mecobalamin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mecobalamin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mecobalamin suppliers with NDC on PharmaCompass.
Mecobalamin 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 Mecobalamin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Mecobalamin GMP manufacturer or Mecobalamin GMP API supplier for your needs.
A Mecobalamin CoA (Certificate of Analysis) is a formal document that attests to Mecobalamin's compliance with Mecobalamin specifications and serves as a tool for batch-level quality control.
Mecobalamin CoA mostly includes findings from lab analyses of a specific batch. For each Mecobalamin 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.
Mecobalamin may be tested according to a variety of international standards, such as European Pharmacopoeia (Mecobalamin EP), Mecobalamin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mecobalamin USP).
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