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

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01 Suanfarma Italia SpA (1)

02 Biocon Limited (1)

03 Chong Kun Dang Bio Co., Ltd. @ [Starting material ‘mycophenolic acid’ manufacturing site] Livzon Group (Ningxia) Pharmaceutical Co., Ltd (1)

04 Emcure Pharmaceuticals Limited (1)

05 Novartis Pharma Schweizerhalle AG@Suanfarma Italia SpA@Novartis Pharma Stein AG (1)

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01 Chong Kun Dang Bio Co., Ltd. (1)

02 Leesung International Co., Ltd. (1)

03 Mpeak Korea Co., Ltd. (1)

04 Novartis Korea Co., Ltd. (2)

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01 Micronized mycophenolate sodium (1)

02 Mycophenolate Sodium (4)

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01 India (2)

02 South Korea (1)

03 Spain (1)

04 Switzerland (1)

URL Supplier Web Content
Novartis Korea Co., Ltd.
2021-06-21
20210621-209-J-1031
Suanfarma Italia SpA
Italy
Corso Verona, 165-38068 R...
URL Supplier Web Content
Leesung International Co., Ltd.
2021-07-27
20210727-209-J-991
Biocon Limited
India
20th KM. Hosur Road Elect...
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Chong Kun Dang Bio Co., Ltd.
2019-11-27
20191127-209-J-232
Chong Kun Dang Bio Co., L...
South Korea
#101, Building 2-1, Build...
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Mpeak Korea Co., Ltd.
2023-04-14
20230414-209-J-1476
Emcure Pharmaceuticals Li...
India
Plot No. D-24 & D-24/1, K...
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Novartis Korea Co., Ltd.
2021-12-01
20211201-209-J-1165
Novartis Pharma Schweizer...
Switzerland
Rothausstrasse, Pratteln,...
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Looking for 37415-62-6 / Mycophenolate Sodium API manufacturers, exporters & distributors?

Mycophenolate Sodium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Mycophenolate Sodium

Synonyms

37415-62-6, Sodium mycophenolate, Mycophenolic acid sodium salt, Mycophenolic acid monosodium salt, Erl 080, Mycophenolate sodium [usan]

Cas Number

37415-62-6

Unique Ingredient Identifier (UNII)

WX877SQI1G

About Mycophenolate Sodium

Compound derived from Penicillium stoloniferum and related species. It blocks de novo biosynthesis of purine nucleotides by inhibition of the enzyme inosine monophosphate dehydrogenase (IMP DEHYDROGENASE). Mycophenolic acid exerts selective effects on the immune system in which it prevents the proliferation of T-CELLS, LYMPHOCYTES, and the formation of antibodies from B-CELLS. It may also inhibit recruitment of LEUKOCYTES to sites of INFLAMMATION.

Mycophenolate Sodium Manufacturers

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

Mycophenolate Sodium Suppliers

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

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

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

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

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

Mycophenolate Sodium Manufacturers | Traders | Suppliers

Mycophenolate Sodium Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Mycophenolate Sodium

Get in contact with the supplier of your choice:

  1. Suanfarma
  2. Biocon
  3. CKD Bio Corporation
  4. Emcure Pharmaceuticals
  5. Novartis Pharmaceuticals Corporation
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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