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

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01 FDC Limited (2)

02 Urquima S.A. (1)

03 Vasudha Pharma Chem Limited@ [Manufacturer of Desloratadine] Vasudha Pharma Chem Limited (1)

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01 Anguk Pharmaceutical Co., Ltd. (1)

02 Classia Co., Ltd. (1)

03 Hiple Co., Ltd. (1)

04 Kookjeon Pharmaceutical Co., Ltd. (1)

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01 Rupatadine fumarate (4)

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01 India (3)

02 Spain (1)

URL Supplier Web Content
Classia Co., Ltd.
2021-07-23
Wed173-28-ND(1)
FDC Limited
India
Plot No. 19 & 20/2, MIDC,...
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URL Supplier Web Content
Kookjeon Pharmaceutical Co., Ltd.
2020-10-19
Wed173-28-ND
FDC Limited
India
Plot No. 19 & 20/2, MIDC,...
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Anguk Pharmaceutical Co., Ltd.
2017-01-09
Number 4532-1-ND
Urquima S.A.
Spain
Arnau de Vilanova 22-42 0...
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Hiple Co., Ltd.
2020-09-04
Number 30-4-ND
Vasudha Pharma Chem Limit...
India
Unit-II, Plot No. 79, Jaw...
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Looking for 182349-12-8 / Rupatadine Fumarate API manufacturers, exporters & distributors?

Rupatadine Fumarate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Rupatadine Fumarate

Synonyms

182349-12-8, Rupatadin fumarate, Rupafin, Ur-12592 fumarate, Rupatadine (fumarate), Alergoliber

Cas Number

182349-12-8

Unique Ingredient Identifier (UNII)

XJ6OT32M93

Rupatadine Manufacturers

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

Rupatadine Suppliers

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

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

Rupatadine KDMF

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

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

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

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

Rupatadine Manufacturers | Traders | Suppliers

Rupatadine Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Rupatadine

Get in contact with the supplier of your choice:

  1. FDC Limited
  2. Urquima S.A. Grupo Uriach
  3. Vasudha Pharma Chem
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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