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  • TABLET;ORAL - 10MG
  • TABLET;ORAL - 25MG
  • TABLET;ORAL - 50MG

Looking for 113-52-0 / Imipramine Hydrochloride API manufacturers, exporters & distributors?

Imipramine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Imipramine Hydrochloride

Synonyms

113-52-0, Imipramine hcl, Tofranil, Pryleugan, Imizine, Chimoreptin

Cas Number

113-52-0

Unique Ingredient Identifier (UNII)

BKE5Q1J60U

About Imipramine Hydrochloride

The prototypical tricyclic antidepressant. It has been used in major depression, dysthymia, bipolar depression, attention-deficit disorders, agoraphobia, and panic disorders. It has less sedative effect than some other members of this therapeutic group.

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine Manufacturers

A 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine, including repackagers and relabelers. The FDA regulates 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine Suppliers

A 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine supplier is an individual or a company that provides 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine active pharmaceutical ingredient (API) or 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine finished formulations upon request. The 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine suppliers may include 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine API manufacturers, exporters, distributors and traders.

click here to find a list of 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine USDMF

A 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine DMF (Drug Master File) is a document detailing the whole manufacturing process of 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine active pharmaceutical ingredient (API) in detail. Different forms of 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine DMFs exist exist since differing nations have different regulations, such as 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine DMF submitted to regulatory agencies in the US is known as a USDMF. 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine USDMF includes data on 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine suppliers with USDMF on PharmaCompass.

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine Drug Master File in Japan (10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine JDMF) empowers 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine JDMF during the approval evaluation for pharmaceutical products. At the time of 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine suppliers with JDMF on PharmaCompass.

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine Drug Master File in Korea (10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine. The MFDS reviews the 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine KDMF as part of the drug registration process and uses the information provided in the 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine KDMF to evaluate the safety and efficacy of the drug.

After submitting a 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine suppliers with KDMF on PharmaCompass.

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine CEP

A 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine CEP of the European Pharmacopoeia monograph is often referred to as a 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine Certificate of Suitability (COS). The purpose of a 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine to their clients by showing that a 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine CEP has been issued for it. The manufacturer submits a 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine CEP (COS) as part of the market authorization procedure, and it takes on the role of a 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine CEP holder for the record. Additionally, the data presented in the 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine DMF.

A 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine suppliers with CEP (COS) on PharmaCompass.

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine WC

A 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine written confirmation (10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine WC) is an official document issued by a regulatory agency to a 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine manufacturer, verifying that the manufacturing facility of a 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine APIs or 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine finished pharmaceutical products to another nation, regulatory agencies frequently require a 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine WC (written confirmation) as part of the regulatory process.

click here to find a list of 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine suppliers with Written Confirmation (WC) on PharmaCompass.

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine suppliers with NDC on PharmaCompass.

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine GMP

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine GMP manufacturer or 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine GMP API supplier for your needs.

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine CoA

A 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine CoA (Certificate of Analysis) is a formal document that attests to 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine's compliance with 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine specifications and serves as a tool for batch-level quality control.

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine CoA mostly includes findings from lab analyses of a specific batch. For each 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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.

10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine may be tested according to a variety of international standards, such as European Pharmacopoeia (10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine EP), 10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (10,11-Dihydro-N,N-dimethyl- dibenz[b,f]azepine-5- propanamine 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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