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Looking for 53-19-0 / Mitotane API manufacturers, exporters & distributors?

Mitotane manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Mitotane 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 Mitotane manufacturer or Mitotane supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mitotane manufacturer or Mitotane supplier.

PharmaCompass also assists you with knowing the Mitotane API Price utilized in the formulation of products. Mitotane API Price is not always fixed or binding as the Mitotane Price is obtained through a variety of data sources. The Mitotane Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Mitotane

Synonyms

53-19-0, Mitotan, Lysodren, O,p'-ddd, Chlodithane, Chloditan

Cas Number

53-19-0

Unique Ingredient Identifier (UNII)

78E4J5IB5J

About Mitotane

A derivative of the insecticide DICHLORODIPHENYLDICHLOROETHANE that specifically inhibits cells of the adrenal cortex and their production of hormones. It is used to treat adrenocortical tumors and causes CNS damage, but no bone marrow depression.

MolPort-001-779-578 Manufacturers

A MolPort-001-779-578 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MolPort-001-779-578, including repackagers and relabelers. The FDA regulates MolPort-001-779-578 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MolPort-001-779-578 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 MolPort-001-779-578 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

MolPort-001-779-578 Suppliers

A MolPort-001-779-578 supplier is an individual or a company that provides MolPort-001-779-578 active pharmaceutical ingredient (API) or MolPort-001-779-578 finished formulations upon request. The MolPort-001-779-578 suppliers may include MolPort-001-779-578 API manufacturers, exporters, distributors and traders.

click here to find a list of MolPort-001-779-578 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

MolPort-001-779-578 USDMF

A MolPort-001-779-578 DMF (Drug Master File) is a document detailing the whole manufacturing process of MolPort-001-779-578 active pharmaceutical ingredient (API) in detail. Different forms of MolPort-001-779-578 DMFs exist exist since differing nations have different regulations, such as MolPort-001-779-578 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A MolPort-001-779-578 DMF submitted to regulatory agencies in the US is known as a USDMF. MolPort-001-779-578 USDMF includes data on MolPort-001-779-578's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MolPort-001-779-578 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of MolPort-001-779-578 suppliers with USDMF on PharmaCompass.

MolPort-001-779-578 JDMF

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 MolPort-001-779-578 Drug Master File in Japan (MolPort-001-779-578 JDMF) empowers MolPort-001-779-578 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 MolPort-001-779-578 JDMF during the approval evaluation for pharmaceutical products. At the time of MolPort-001-779-578 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 MolPort-001-779-578 suppliers with JDMF on PharmaCompass.

MolPort-001-779-578 NDC

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 MolPort-001-779-578 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for MolPort-001-779-578 API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 MolPort-001-779-578 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain MolPort-001-779-578 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MolPort-001-779-578 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of MolPort-001-779-578 suppliers with NDC on PharmaCompass.

MolPort-001-779-578 GMP

MolPort-001-779-578 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 MolPort-001-779-578 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 MolPort-001-779-578 GMP manufacturer or MolPort-001-779-578 GMP API supplier for your needs.

MolPort-001-779-578 CoA

A MolPort-001-779-578 CoA (Certificate of Analysis) is a formal document that attests to MolPort-001-779-578's compliance with MolPort-001-779-578 specifications and serves as a tool for batch-level quality control.

MolPort-001-779-578 CoA mostly includes findings from lab analyses of a specific batch. For each MolPort-001-779-578 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.

MolPort-001-779-578 may be tested according to a variety of international standards, such as European Pharmacopoeia (MolPort-001-779-578 EP), MolPort-001-779-578 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MolPort-001-779-578 USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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