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API SUPPLIERS
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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NDC
KDMF
ASMF, CA
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
CEP/COS
NDC
ASMF, BR...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Aspen API. More than just an API™
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
CEP/COS
EU-WC
KDMF
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
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USDMF
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Certificate Number : R1-CEP 2003-247 - Rev 01
Status : Valid
Issue Date : 2020-07-30
Type : Chemical
Substance Number : 653
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Certificate Number : CEP 2018-280 - Rev 02
Status : Valid
Issue Date : 2025-01-22
Type : Chemical
Substance Number : 653
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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registration Number : 230MF10014
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2018-01-30
Latest Date of Registration : 2019-03-19
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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0150
Address of the Firm : APIUnit-l,R.SNo50/1,Mukteswarapuram Village, Jaggaiahpet Mandal, NTRDistrict-521...
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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2019-01-24
Registration Number : 20181018-209-J-161(3)
Manufacturer Name : Pharmaceutical Works Polphar...
Manufacturer Address : 19, Pelplinska Str.83-200 Starogard Gdanski, Poland
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2019-01-11
Registration Number : 20181018-209-J-161(2)
Manufacturer Name : Pharmaceutical Works Polphar...
Manufacturer Address : 19, Pelplinska Street. 83-200 Starogard Gdanski, Poland
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registrant Name : Taejun Pharmaceutical Co., Ltd.
Registration Date : 2019-06-14
Registration Number : 20181018-209-J-161(4)
Manufacturer Name : Pharmaceutical Works Polphar...
Manufacturer Address : 19, Pelplinska Street. 83-200 Starogard Gdanski, Poland
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-12-03
Registration Number : 20181018-209-J-161(1)
Manufacturer Name : Pharmaceutical Works Polphar...
Manufacturer Address : 19, Pelplinska Street. 83-200 Starogard Gdanski, Poland
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2018-10-18
Registration Number : 20181018-209-J-161
Manufacturer Name : Pharmaceutical Works Polphar...
Manufacturer Address : 19, Pelplinska Street. 83-200 Starogard Gdanski, Poland
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2019-08-02
Registration Number : 20181018-209-J-161(5)
Manufacturer Name : Pharmaceutical Works Polphar...
Manufacturer Address : 19, Pelplinska Street. 83-200 Starogard Gdanski, Poland
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-06-29
Registration Number : 20210629-209-J-1043
Manufacturer Name : Cohance Lifesciences Limited
Manufacturer Address : RS 50/1, Mukteswarapuram Village, Jaggaiahpeta Mandal, Krishna District-521 175. Andh...
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DOSAGE - SOLUTION;ORAL - 10MG/5ML
USFDA APPLICATION NUMBER - 208193
DOSAGE - SOLUTION;ORAL - 5MG/5ML
USFDA APPLICATION NUMBER - 208193
DOSAGE - INJECTABLE;INTRATHECAL - 0.05MG/ML
USFDA APPLICATION NUMBER - 22462
DOSAGE - INJECTABLE;INTRATHECAL - 0.5MG/ML
USFDA APPLICATION NUMBER - 22462
DOSAGE - INJECTABLE;INTRATHECAL - 1MG/ML
USFDA APPLICATION NUMBER - 22462
DOSAGE - INJECTABLE;INTRATHECAL - 2MG/ML
USFDA APPLICATION NUMBER - 22462
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Baclofen 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 Baclofen manufacturer or Baclofen supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Baclofen manufacturer or Baclofen supplier.
PharmaCompass also assists you with knowing the Baclofen API Price utilized in the formulation of products. Baclofen API Price is not always fixed or binding as the Baclofen Price is obtained through a variety of data sources. The Baclofen Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Alphapharm Brand of Baclofen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alphapharm Brand of Baclofen, including repackagers and relabelers. The FDA regulates Alphapharm Brand of Baclofen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alphapharm Brand of Baclofen 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 Alphapharm Brand of Baclofen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alphapharm Brand of Baclofen supplier is an individual or a company that provides Alphapharm Brand of Baclofen active pharmaceutical ingredient (API) or Alphapharm Brand of Baclofen finished formulations upon request. The Alphapharm Brand of Baclofen suppliers may include Alphapharm Brand of Baclofen API manufacturers, exporters, distributors and traders.
click here to find a list of Alphapharm Brand of Baclofen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alphapharm Brand of Baclofen DMF (Drug Master File) is a document detailing the whole manufacturing process of Alphapharm Brand of Baclofen active pharmaceutical ingredient (API) in detail. Different forms of Alphapharm Brand of Baclofen DMFs exist exist since differing nations have different regulations, such as Alphapharm Brand of Baclofen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alphapharm Brand of Baclofen DMF submitted to regulatory agencies in the US is known as a USDMF. Alphapharm Brand of Baclofen USDMF includes data on Alphapharm Brand of Baclofen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alphapharm Brand of Baclofen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alphapharm Brand of Baclofen 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 Alphapharm Brand of Baclofen Drug Master File in Japan (Alphapharm Brand of Baclofen JDMF) empowers Alphapharm Brand of Baclofen 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 Alphapharm Brand of Baclofen JDMF during the approval evaluation for pharmaceutical products. At the time of Alphapharm Brand of Baclofen 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 Alphapharm Brand of Baclofen 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 Alphapharm Brand of Baclofen Drug Master File in Korea (Alphapharm Brand of Baclofen KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alphapharm Brand of Baclofen. The MFDS reviews the Alphapharm Brand of Baclofen KDMF as part of the drug registration process and uses the information provided in the Alphapharm Brand of Baclofen KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alphapharm Brand of Baclofen 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 Alphapharm Brand of Baclofen API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alphapharm Brand of Baclofen suppliers with KDMF on PharmaCompass.
A Alphapharm Brand of Baclofen CEP of the European Pharmacopoeia monograph is often referred to as a Alphapharm Brand of Baclofen Certificate of Suitability (COS). The purpose of a Alphapharm Brand of Baclofen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alphapharm Brand of Baclofen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alphapharm Brand of Baclofen to their clients by showing that a Alphapharm Brand of Baclofen CEP has been issued for it. The manufacturer submits a Alphapharm Brand of Baclofen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alphapharm Brand of Baclofen CEP holder for the record. Additionally, the data presented in the Alphapharm Brand of Baclofen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alphapharm Brand of Baclofen DMF.
A Alphapharm Brand of Baclofen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alphapharm Brand of Baclofen 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 Alphapharm Brand of Baclofen suppliers with CEP (COS) on PharmaCompass.
A Alphapharm Brand of Baclofen written confirmation (Alphapharm Brand of Baclofen WC) is an official document issued by a regulatory agency to a Alphapharm Brand of Baclofen manufacturer, verifying that the manufacturing facility of a Alphapharm Brand of Baclofen active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alphapharm Brand of Baclofen APIs or Alphapharm Brand of Baclofen finished pharmaceutical products to another nation, regulatory agencies frequently require a Alphapharm Brand of Baclofen WC (written confirmation) as part of the regulatory process.
click here to find a list of Alphapharm Brand of Baclofen 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 Alphapharm Brand of Baclofen as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alphapharm Brand of Baclofen 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 Alphapharm Brand of Baclofen 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 Alphapharm Brand of Baclofen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alphapharm Brand of Baclofen NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alphapharm Brand of Baclofen suppliers with NDC on PharmaCompass.
Alphapharm Brand of Baclofen 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 Alphapharm Brand of Baclofen 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 Alphapharm Brand of Baclofen GMP manufacturer or Alphapharm Brand of Baclofen GMP API supplier for your needs.
A Alphapharm Brand of Baclofen CoA (Certificate of Analysis) is a formal document that attests to Alphapharm Brand of Baclofen's compliance with Alphapharm Brand of Baclofen specifications and serves as a tool for batch-level quality control.
Alphapharm Brand of Baclofen CoA mostly includes findings from lab analyses of a specific batch. For each Alphapharm Brand of Baclofen 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.
Alphapharm Brand of Baclofen may be tested according to a variety of international standards, such as European Pharmacopoeia (Alphapharm Brand of Baclofen EP), Alphapharm Brand of Baclofen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alphapharm Brand of Baclofen USP).
