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List of Korea Drug Master Files (KDMF) for Diclofenac Sodium Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Masung LS Co., Ltd.
2023-10-24
20111111-80-D-108-12(A)
Amoli Organics Pvt. Ltd
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Sungwoo Chemical Co., Ltd.
2013-05-02
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Shinil Pharmaceutical Co., Ltd.
2016-07-15
20111111-80-D-108-12(2)
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Dongbang FTL Co., Ltd.
2007-05-21
20070521-80-D-9-01
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IMCD Korea Co., Ltd.
2013-06-27
20081031-80-D-46-06(4)
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KR Farm Co., Ltd.
2012-10-12
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2012-10-11
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2015-05-29
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Korea Union Pharmaceutical Co., Ltd.
2011-09-23
20110923-80-D-94-11
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2011-06-30
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Hwadeok Pharmaceutical Co., Ltd.
2011-08-19
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  • TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;TOPICAL - 2%
  • TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG
  • TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG
  • SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL;TOPICAL - 1%
  • SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 15307-79-6 / Diclofenac Sodium API manufacturers, exporters & distributors?

Diclofenac Sodium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Diclofenac Sodium

Synonyms

Qtg126297q, Voltaren, 15307-79-6, Diclofenac sodium salt, Sodium diclofenac, Prophenatin

Cas Number

15307-79-6

Unique Ingredient Identifier (UNII)

QTG126297Q

About Diclofenac Sodium

A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.

Diclofenac Sodium Manufacturers

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

Diclofenac Sodium Suppliers

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

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

Diclofenac Sodium KDMF

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

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

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

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

Diclofenac Sodium Manufacturers | Traders | Suppliers

Diclofenac Sodium Manufacturers, Traders, Suppliers 1
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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