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API SUPPLIERS
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
CEP/COS 
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
Sigma-Aldrich empowers scientific discovery with top-quality solutions to accelerate research, innovation, and better health worldwide.
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USDMF
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-20
Pay. Date : 2020-07-21
DMF Number : 34935
Submission : 2020-07-30
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-21
Pay. Date : 2016-08-22
DMF Number : 30814
Submission : 2016-08-20
Status :
Type : II
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Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
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, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API / Semi finish form...
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DOSAGE - CAPSULE;ORAL - 25MG
USFDA APPLICATION NUMBER - 19906
DOSAGE - CAPSULE;ORAL - 50MG
USFDA APPLICATION NUMBER - 19906
DOSAGE - CAPSULE;ORAL - 75MG
USFDA APPLICATION NUMBER - 19906
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Clomipramine 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 Clomipramine Hydrochloride manufacturer or Clomipramine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clomipramine Hydrochloride manufacturer or Clomipramine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Clomipramine Hydrochloride API Price utilized in the formulation of products. Clomipramine Hydrochloride API Price is not always fixed or binding as the Clomipramine Hydrochloride Price is obtained through a variety of data sources. The Clomipramine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH], including repackagers and relabelers. The FDA regulates CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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 CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] supplier is an individual or a company that provides CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] active pharmaceutical ingredient (API) or CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] finished formulations upon request. The CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] suppliers may include CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] API manufacturers, exporters, distributors and traders.
click here to find a list of CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] DMF (Drug Master File) is a document detailing the whole manufacturing process of CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] active pharmaceutical ingredient (API) in detail. Different forms of CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] DMFs exist exist since differing nations have different regulations, such as CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] DMF submitted to regulatory agencies in the US is known as a USDMF. CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] USDMF includes data on CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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 CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] Drug Master File in Japan (CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] JDMF) empowers CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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 CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] JDMF during the approval evaluation for pharmaceutical products. At the time of CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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 CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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 CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] Drug Master File in Korea (CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH]. The MFDS reviews the CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] KDMF as part of the drug registration process and uses the information provided in the CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] KDMF to evaluate the safety and efficacy of the drug.
After submitting a CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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 CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] suppliers with KDMF on PharmaCompass.
A CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] CEP of the European Pharmacopoeia monograph is often referred to as a CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] Certificate of Suitability (COS). The purpose of a CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] to their clients by showing that a CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] CEP has been issued for it. The manufacturer submits a CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] CEP (COS) as part of the market authorization procedure, and it takes on the role of a CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] CEP holder for the record. Additionally, the data presented in the CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] DMF.
A CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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 CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] suppliers with CEP (COS) on PharmaCompass.
A CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] written confirmation (CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] WC) is an official document issued by a regulatory agency to a CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] manufacturer, verifying that the manufacturing facility of a CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] APIs or CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] finished pharmaceutical products to another nation, regulatory agencies frequently require a CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] WC (written confirmation) as part of the regulatory process.
click here to find a list of CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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 CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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 CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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 CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] suppliers with NDC on PharmaCompass.
CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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 CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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 CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] GMP manufacturer or CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] GMP API supplier for your needs.
A CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] CoA (Certificate of Analysis) is a formal document that attests to CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH]'s compliance with CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] specifications and serves as a tool for batch-level quality control.
CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] CoA mostly includes findings from lab analyses of a specific batch. For each CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] 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.
CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] may be tested according to a variety of international standards, such as European Pharmacopoeia (CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] EP), CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CLOMIPRAMINE HYDROCHLORIDE [EP MONOGRAPH] USP).
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