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KDMF
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
NDC
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-27
Pay. Date : 2014-08-20
DMF Number : 15442
Submission : 2001-05-14
Status :
Type : II
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38657
Submission : 2023-11-08
Status :
Type : II
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Registrant Name : Koojoo Pharmaceutical Co., Ltd.
Registration Date : 2011-10-21
Registration Number : 20080331-98-E-32-03(1)
Manufacturer Name : chemical factory berk GmbH
Manufacturer Address : Mainthalstrasse 3 D-06749 bitterfeld
Registrant Name : Korea BMI Co., Ltd.
Registration Date : 2013-07-15
Registration Number : 20080331-98-E-32-03(5)
Manufacturer Name : chemical factory berg GmbH
Manufacturer Address : Mainthalstrasse 3 D-06749 Bitterfeld
Registrant Name : Hyons Co., Ltd.
Registration Date : 2008-03-31
Registration Number : 20080331-98-E-32-03
Manufacturer Name : chemical factory berg GmbH
Manufacturer Address : Mainthalstrasse 3 D-06749 bitterfeld
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2013-02-14
Registration Number : 20080331-98-E-32-03(4)
Manufacturer Name : chemical factory berg GmbH
Manufacturer Address : Mainthalstrasse 3 D-06749 bitterfeld
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DOSAGE - TABLET;ORAL - 37.5MG
USFDA APPLICATION NUMBER - 85128
DOSAGE - CAPSULE;ORAL - 30MG
USFDA APPLICATION NUMBER - 86945
DOSAGE - CAPSULE;ORAL - 15MG
USFDA APPLICATION NUMBER - 87190
DOSAGE - CAPSULE;ORAL - 30MG
USFDA APPLICATION NUMBER - 87190
DOSAGE - CAPSULE;ORAL - 37.5MG
USFDA APPLICATION NUMBER - 88023
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ABOUT THIS PAGE
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PharmaCompass offers a list of Phentermine 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 Phentermine Hydrochloride manufacturer or Phentermine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phentermine Hydrochloride manufacturer or Phentermine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Phentermine Hydrochloride API Price utilized in the formulation of products. Phentermine Hydrochloride API Price is not always fixed or binding as the Phentermine Hydrochloride Price is obtained through a variety of data sources. The Phentermine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Phentermine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phentermine Hydrochloride, including repackagers and relabelers. The FDA regulates Phentermine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phentermine Hydrochloride 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 Phentermine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phentermine Hydrochloride supplier is an individual or a company that provides Phentermine Hydrochloride active pharmaceutical ingredient (API) or Phentermine Hydrochloride finished formulations upon request. The Phentermine Hydrochloride suppliers may include Phentermine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Phentermine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phentermine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Phentermine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Phentermine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Phentermine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phentermine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Phentermine Hydrochloride USDMF includes data on Phentermine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phentermine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phentermine Hydrochloride suppliers with USDMF 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 Phentermine Hydrochloride Drug Master File in Korea (Phentermine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Phentermine Hydrochloride. The MFDS reviews the Phentermine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Phentermine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Phentermine Hydrochloride 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 Phentermine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Phentermine Hydrochloride suppliers with KDMF on PharmaCompass.
A Phentermine Hydrochloride written confirmation (Phentermine Hydrochloride WC) is an official document issued by a regulatory agency to a Phentermine Hydrochloride manufacturer, verifying that the manufacturing facility of a Phentermine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Phentermine Hydrochloride APIs or Phentermine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Phentermine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Phentermine Hydrochloride 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 Phentermine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Phentermine Hydrochloride 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 Phentermine Hydrochloride 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 Phentermine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Phentermine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Phentermine Hydrochloride suppliers with NDC on PharmaCompass.
Phentermine Hydrochloride 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 Phentermine Hydrochloride 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 Phentermine Hydrochloride GMP manufacturer or Phentermine Hydrochloride GMP API supplier for your needs.
A Phentermine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Phentermine Hydrochloride's compliance with Phentermine Hydrochloride specifications and serves as a tool for batch-level quality control.
Phentermine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Phentermine Hydrochloride 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.
Phentermine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Phentermine Hydrochloride EP), Phentermine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Phentermine Hydrochloride USP).
