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

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01 Pharmaceutical Works Polpharma S.A. (6)

02 Pharmaceutical Works polpharma SA@Hwail Pharmaceutical Co., Ltd. (1)

03 Assia Chemical Industries Ltd (7)

04 Assia Chemical Industries Ltd., (1)

05 Aurobindo Pharma Limited (1)

06 Aurobindo Pharma Limited (Unit-XI) (1)

07 Boryung Pharmaceutical Co., Ltd. (1)

08 Fleming Laboratories Limited (7)

09 Ind-Swift Laboratories Limited (1)

10 Inist ST Co., Ltd. (1)

11 Lonza Ltd (1)

12 UNION QUIMICO FARMACEUTICA, SA (1)

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01 Agerson Bio Co., Ltd. (1)

02 Anguk Pharmaceutical Co., Ltd. (1)

03 Boryeong Co., Ltd. (1)

04 Chong Kun Dang Co., Ltd. (1)

05 Hallym Pharmaceutical Co., Ltd. (1)

06 Hanmi Pharmaceutical Co., Ltd. (1)

07 Hwail Pharmaceutical Co., Ltd. (2)

08 Hwanin Pharmaceutical Co., Ltd. (1)

09 Ildong Pharmaceutical Co., Ltd. (1)

10 Inist ST Co., Ltd. (1)

11 JW Pharmaceutical Co., Ltd. (1)

12 Kolon Pharmaceutical Co., Ltd. (2)

13 Korea United Pharmaceutical Co., Ltd. (1)

14 Lihu Healthcare Co., Ltd. (1)

15 Medica Korea Co., Ltd. (1)

16 Pharmapia Co., Ltd. (2)

17 Samil Pharmaceutical Co., Ltd. (1)

18 Samo Pharmaceutical Co., Ltd. (1)

19 Seongui Bio Co., Ltd. (1)

20 Shinil Pharmaceutical Co., Ltd. (1)

21 Sungjin Exim Co., Ltd. (2)

22 Sungwoo Chemical Co., Ltd. (1)

23 Wooshin Rabotachi Co., Ltd. (1)

24 Yuhan Corporation (1)

25 Yuyu Pharmaceutical Co., Ltd. (1)

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01 Sodium risedronate (29)

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01 India (10)

02 Israel (8)

03 Poland (7)

04 South Korea (2)

05 Spain (1)

06 U.S.A (1)

Agerson Bio Co., Ltd.
2022-01-21
20100226-121-G-15-07(6)
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
Wooshin Rabotachi Co., Ltd.
2011-07-15
20100226-121-G-15-07(3)
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
Hallym Pharmaceutical Co., Ltd.
2011-04-14
20100226-121-G-15-07(1)
Pharmaceutical Works Polp...
Poland
19, Pelplinska str 83-200...
Anguk Pharmaceutical Co., Ltd.
2011-06-30
20100226-121-G-15-07(4)
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
Hwail Pharmaceutical Co., Ltd.
2011-06-15
20100226-121-G-15-07(2)
Pharmaceutical Works polp...
Poland
19, Pelplinska st 83-200 ...
Hwail Pharmaceutical Co., Ltd.
2010-02-26
20100226-121-G-15-07
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
Korea United Pharmaceutical Co., Ltd.
2011-07-29
20100226-121-G-15-07(5)
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
URL Supplier Web Content
Seongui Bio Co., Ltd.
2013-01-24
20100211-121-G-3-06(1)
Aurobindo Pharma Limited
India
Unit PIN: 532 409
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Lihu Healthcare Co., Ltd.
2017-09-01
20100129-121-G-22-04(6)
Fleming Laboratories Limi...
India
Plot No.152&160, Phase-V,...
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URL Supplier Web Content
Sungjin Exim Co., Ltd.
2013-04-18
20130418-121-G-113-12
UNION QUIMICO FARMACEUTIC...
Spain
Poligon Industrial Moli d...
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Looking for 115436-72-1 / Risedronate Sodium API manufacturers, exporters & distributors?

Risedronate Sodium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Risedronate Sodium

Synonyms

Sodium risedronate, 115436-72-1, Actonel, Atelvia, Risedronate (sodium), Ne 58095

Cas Number

115436-72-1

Unique Ingredient Identifier (UNII)

OFG5EXG60L

About Risedronate Sodium

A pyridine and diphosphonic acid derivative that acts as a CALCIUM CHANNEL BLOCKER and inhibits BONE RESORPTION.

Risedronic Acid Manufacturers

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

Risedronic Acid Suppliers

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

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

Risedronic Acid KDMF

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

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

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

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

Risedronic Acid Manufacturers | Traders | Suppliers

Risedronic Acid 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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