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

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01 Daepyeong Co., Ltd. (1)

02 Hyundai Bioland Co., Ltd. (1)

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01 Daepyeong Co., Ltd. (1)

02 Hyundai Bioland Co., Ltd. (1)

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01 corydalis B (2)

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01 South Korea (2)

URL Supplier Web Content
Daepyeong Co., Ltd.
2017-12-19
20171219-13-K-18-01
Daepyeong Co., Ltd.
South Korea
19-8 Yeongdong-gil, Hamch...
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URL Supplier Web Content
Hyundai Bioland Co., Ltd.
2018-09-11
20180911-13-K-41-02
Hyundai Bioland Co., Ltd.
South Korea
22 Osongsaengmyeong 2-ro,...
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Looking for 483-14-7 / Rotundine API manufacturers, exporters & distributors?

Rotundine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Rotundine

Synonyms

483-14-7, L-tetrahydropalmatine, (-)-tetrahydropalmatine, Gindarine, Caseanine, Hyndarine

Cas Number

483-14-7

Unique Ingredient Identifier (UNII)

3X69CO5I79

About Rotundine

tetrahydropalmatine is a natural product found in Corydalis heterocarpa, Ceratocapnos heterocarpa, and other organisms with data available.

Rotundine Manufacturers

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

Rotundine Suppliers

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

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

Rotundine KDMF

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

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

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

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

Rotundine Manufacturers | Traders | Suppliers

Rotundine Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Rotundine

Get in contact with the supplier of your choice:

  1. Daepyeong
  2. Hyundai Bioland
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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