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API SUPPLIERS
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USDMF
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Date of Issue : 2025-09-02
Valid Till : 2028-07-02
Written Confirmation Number : WC-0218
Address of the Firm : A-5/2, Late Parshuram Industrial Area, MIDC, Tal-Khed, Dist. Ratnagiri-415 722, ...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Chlorpheniramine Maleate BP/Ph. Eur
Date of Issue : 2025-09-02
Valid Till : 2028-07-02
Written Confirmation Number : WC-0218
Address of the Firm : A-5/2, Late Parshuram Industrial Area, MIDC, Tal-Khed, Dist. Ratnagiri-415 722, ...
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
About the Company : Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top API manufacturer in th...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a hi...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...
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...
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DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML
USFDA APPLICATION NUMBER - 204307
DOSAGE - TABLET;ORAL - 2MG;200MG;30MG
USFDA APPLICATION NUMBER - 21441
DOSAGE - TABLET;ORAL - 4MG;200MG;10MG
USFDA APPLICATION NUMBER - 22113
DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG...DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22439
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 7638
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 7638
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PharmaCompass offers a list of Chlorpheniramine Maleate 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 Chlorpheniramine Maleate manufacturer or Chlorpheniramine Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Chlorpheniramine Maleate manufacturer or Chlorpheniramine Maleate supplier.
A Chlorphenamine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorphenamine Maleate, including repackagers and relabelers. The FDA regulates Chlorphenamine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorphenamine Maleate 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 Chlorphenamine Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Chlorphenamine Maleate supplier is an individual or a company that provides Chlorphenamine Maleate active pharmaceutical ingredient (API) or Chlorphenamine Maleate finished formulations upon request. The Chlorphenamine Maleate suppliers may include Chlorphenamine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Chlorphenamine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Chlorphenamine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlorphenamine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Chlorphenamine Maleate DMFs exist exist since differing nations have different regulations, such as Chlorphenamine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlorphenamine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Chlorphenamine Maleate USDMF includes data on Chlorphenamine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlorphenamine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chlorphenamine Maleate 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 Chlorphenamine Maleate Drug Master File in Japan (Chlorphenamine Maleate JDMF) empowers Chlorphenamine Maleate 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 Chlorphenamine Maleate JDMF during the approval evaluation for pharmaceutical products. At the time of Chlorphenamine Maleate 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 Chlorphenamine Maleate 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 Chlorphenamine Maleate Drug Master File in Korea (Chlorphenamine Maleate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Chlorphenamine Maleate. The MFDS reviews the Chlorphenamine Maleate KDMF as part of the drug registration process and uses the information provided in the Chlorphenamine Maleate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Chlorphenamine Maleate 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 Chlorphenamine Maleate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Chlorphenamine Maleate suppliers with KDMF on PharmaCompass.
A Chlorphenamine Maleate written confirmation (Chlorphenamine Maleate WC) is an official document issued by a regulatory agency to a Chlorphenamine Maleate manufacturer, verifying that the manufacturing facility of a Chlorphenamine Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Chlorphenamine Maleate APIs or Chlorphenamine Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Chlorphenamine Maleate WC (written confirmation) as part of the regulatory process.
click here to find a list of Chlorphenamine Maleate 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 Chlorphenamine Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chlorphenamine Maleate 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 Chlorphenamine Maleate 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 Chlorphenamine Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chlorphenamine Maleate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Chlorphenamine Maleate suppliers with NDC on PharmaCompass.
Chlorphenamine Maleate 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 Chlorphenamine Maleate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Chlorphenamine Maleate GMP manufacturer or Chlorphenamine Maleate GMP API supplier for your needs.
A Chlorphenamine Maleate CoA (Certificate of Analysis) is a formal document that attests to Chlorphenamine Maleate's compliance with Chlorphenamine Maleate specifications and serves as a tool for batch-level quality control.
Chlorphenamine Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Chlorphenamine Maleate 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.
Chlorphenamine Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Chlorphenamine Maleate EP), Chlorphenamine Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chlorphenamine Maleate USP).
