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API SUPPLIERS
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USDMF
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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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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 HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clomipramine HCl, including repackagers and relabelers. The FDA regulates Clomipramine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clomipramine HCl 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 HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clomipramine HCl supplier is an individual or a company that provides Clomipramine HCl active pharmaceutical ingredient (API) or Clomipramine HCl finished formulations upon request. The Clomipramine HCl suppliers may include Clomipramine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Clomipramine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clomipramine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Clomipramine HCl active pharmaceutical ingredient (API) in detail. Different forms of Clomipramine HCl DMFs exist exist since differing nations have different regulations, such as Clomipramine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clomipramine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Clomipramine HCl USDMF includes data on Clomipramine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clomipramine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clomipramine HCl 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 HCl Drug Master File in Japan (Clomipramine HCl JDMF) empowers Clomipramine HCl 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 HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Clomipramine HCl 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 HCl 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 HCl Drug Master File in Korea (Clomipramine HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Clomipramine HCl. The MFDS reviews the Clomipramine HCl KDMF as part of the drug registration process and uses the information provided in the Clomipramine HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Clomipramine HCl 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 HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Clomipramine HCl suppliers with KDMF on PharmaCompass.
A Clomipramine HCl CEP of the European Pharmacopoeia monograph is often referred to as a Clomipramine HCl Certificate of Suitability (COS). The purpose of a Clomipramine HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Clomipramine HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Clomipramine HCl to their clients by showing that a Clomipramine HCl CEP has been issued for it. The manufacturer submits a Clomipramine HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Clomipramine HCl CEP holder for the record. Additionally, the data presented in the Clomipramine HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Clomipramine HCl DMF.
A Clomipramine HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clomipramine HCl 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 HCl suppliers with CEP (COS) on PharmaCompass.
A Clomipramine HCl written confirmation (Clomipramine HCl WC) is an official document issued by a regulatory agency to a Clomipramine HCl manufacturer, verifying that the manufacturing facility of a Clomipramine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Clomipramine HCl APIs or Clomipramine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Clomipramine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Clomipramine HCl 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 HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Clomipramine HCl 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 HCl 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 HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clomipramine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Clomipramine HCl suppliers with NDC on PharmaCompass.
Clomipramine HCl 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 HCl 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 HCl GMP manufacturer or Clomipramine HCl GMP API supplier for your needs.
A Clomipramine HCl CoA (Certificate of Analysis) is a formal document that attests to Clomipramine HCl's compliance with Clomipramine HCl specifications and serves as a tool for batch-level quality control.
Clomipramine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Clomipramine HCl 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 HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Clomipramine HCl EP), Clomipramine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clomipramine HCl USP).
