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List of Drug Master Files (KDMF) for Sofosbuvir Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 AMPAC Fine Chemicals LLC_x000D_ (1)

02 Cambrex Charles City, Inc_x000D_ (1)

03 ST Pharm Co., Ltd. (1)

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01 Gilead Sciences Korea Ltd. (3)

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01 Sofosbuvir (3)

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01 South Korea (1)

02 U.S.A (2)

URL Supplier Web Content
Gilead Sciences Korea Ltd.
2015-09-07
Number 6273-4-ND
AMPAC Fine Chemicals LLC_...
U.S.A
Highway 50 & Hazel Avenue...
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URL Supplier Web Content
Gilead Sciences Korea Ltd.
2015-08-26
Number 6273-2-ND
Cambrex Charles City, Inc...
U.S.A
1205 11th Street, Charles...
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Gilead Sciences Korea Ltd.
2015-07-06
Number 6273-1-ND
ST Pharm Co., Ltd.
South Korea
231 Hyeopjeong-ro, Siheun...
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Looking for 1190307-88-0 / Sofosbuvir API manufacturers, exporters & distributors?

Sofosbuvir manufacturers, exporters & distributors 1

64

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

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

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

API | Excipient name

Sofosbuvir

Synonyms

Psi-7977, 1190307-88-0, Sovaldi, Gs-7977, Psi 7977, Gs7977

Cas Number

1190307-88-0

Unique Ingredient Identifier (UNII)

WJ6CA3ZU8B

About Sofosbuvir

A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C.

Sofosbuvir Manufacturers

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

Sofosbuvir Suppliers

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

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

Sofosbuvir KDMF

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

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

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

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

Sofosbuvir Manufacturers | Traders | Suppliers

Sofosbuvir Manufacturers, Traders, Suppliers 1
27

We have 3 companies offering Sofosbuvir

Get in contact with the supplier of your choice:

  1. AMPAC Fine Chemicals
  2. Cambrex Corporation
  3. ST Pharma
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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