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  • TABLET;ORAL - 200MG
  • TABLET;ORAL - 200MG
  • TABLET;ORAL - 200MG;30MG
  • CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT
  • SUSPENSION;ORAL - 100MG/5ML
  • CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
  • CAPSULE;ORAL - 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
  • TABLET;ORAL - 38MG;200MG
  • TABLET;ORAL - 2MG;200MG;30MG
  • TABLET;ORAL - 4MG;200MG;10MG
  • TABLET;ORAL - 200MG;10MG

Looking for 15687-27-1 / Ibuprofen API manufacturers, exporters & distributors?

Ibuprofen manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Ibuprofen 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 Ibuprofen manufacturer or Ibuprofen supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ibuprofen manufacturer or Ibuprofen supplier.

PharmaCompass also assists you with knowing the Ibuprofen API Price utilized in the formulation of products. Ibuprofen API Price is not always fixed or binding as the Ibuprofen Price is obtained through a variety of data sources. The Ibuprofen Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Ibuprofen

Synonyms

15687-27-1, 2-(4-isobutylphenyl)propanoic acid, Motrin, Brufen, Advil, Nuprin

Cas Number

15687-27-1

Unique Ingredient Identifier (UNII)

WK2XYI10QM

About Ibuprofen

A non-steroidal anti-inflammatory agent with analgesic, antipyretic, and anti-inflammatory properties

Spidifen Manufacturers

A Spidifen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spidifen, including repackagers and relabelers. The FDA regulates Spidifen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spidifen 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 Spidifen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Spidifen Suppliers

A Spidifen supplier is an individual or a company that provides Spidifen active pharmaceutical ingredient (API) or Spidifen finished formulations upon request. The Spidifen suppliers may include Spidifen API manufacturers, exporters, distributors and traders.

click here to find a list of Spidifen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Spidifen USDMF

A Spidifen DMF (Drug Master File) is a document detailing the whole manufacturing process of Spidifen active pharmaceutical ingredient (API) in detail. Different forms of Spidifen DMFs exist exist since differing nations have different regulations, such as Spidifen USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Spidifen DMF submitted to regulatory agencies in the US is known as a USDMF. Spidifen USDMF includes data on Spidifen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Spidifen USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Spidifen suppliers with USDMF on PharmaCompass.

Spidifen JDMF

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 Spidifen Drug Master File in Japan (Spidifen JDMF) empowers Spidifen 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 Spidifen JDMF during the approval evaluation for pharmaceutical products. At the time of Spidifen 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 Spidifen suppliers with JDMF on PharmaCompass.

Spidifen KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Spidifen Drug Master File in Korea (Spidifen KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Spidifen. The MFDS reviews the Spidifen KDMF as part of the drug registration process and uses the information provided in the Spidifen KDMF to evaluate the safety and efficacy of the drug.

After submitting a Spidifen 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 Spidifen API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Spidifen suppliers with KDMF on PharmaCompass.

Spidifen CEP

A Spidifen CEP of the European Pharmacopoeia monograph is often referred to as a Spidifen Certificate of Suitability (COS). The purpose of a Spidifen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Spidifen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Spidifen to their clients by showing that a Spidifen CEP has been issued for it. The manufacturer submits a Spidifen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Spidifen CEP holder for the record. Additionally, the data presented in the Spidifen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Spidifen DMF.

A Spidifen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Spidifen 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 Spidifen suppliers with CEP (COS) on PharmaCompass.

Spidifen WC

A Spidifen written confirmation (Spidifen WC) is an official document issued by a regulatory agency to a Spidifen manufacturer, verifying that the manufacturing facility of a Spidifen active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Spidifen APIs or Spidifen finished pharmaceutical products to another nation, regulatory agencies frequently require a Spidifen WC (written confirmation) as part of the regulatory process.

click here to find a list of Spidifen suppliers with Written Confirmation (WC) on PharmaCompass.

Spidifen NDC

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 Spidifen as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Spidifen API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Spidifen 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Spidifen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Spidifen NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Spidifen suppliers with NDC on PharmaCompass.

Spidifen GMP

Spidifen 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 Spidifen 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 Spidifen GMP manufacturer or Spidifen GMP API supplier for your needs.

Spidifen CoA

A Spidifen CoA (Certificate of Analysis) is a formal document that attests to Spidifen's compliance with Spidifen specifications and serves as a tool for batch-level quality control.

Spidifen CoA mostly includes findings from lab analyses of a specific batch. For each Spidifen 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.

Spidifen may be tested according to a variety of international standards, such as European Pharmacopoeia (Spidifen EP), Spidifen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Spidifen USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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