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List of Korea Drug Master Files (KDMF) for Ibandronate Sodium Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Flag Poland
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Wooshin Rabotachi Co., Ltd.
2019-08-02
Number 2417-3-ND(1)
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
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Hwail Pharmaceutical Co., Ltd.
2013-01-21
Number 2417-3-ND
Pharmaceutical Works Polp...
Poland
19, Pelplinska Str. 83-20...
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Samo Pharmaceutical Co., Ltd.
2013-04-18
Wed711-15-ND
Dr. Reddy's Laboratories ...
India
Chemical technology opera...
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Samo Pharmaceutical Co., Ltd.
2010-09-30
711-5-ND
Asia Chemical Industries ...
Israel
Neot-Hovav Eco-Industrial...
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Pharmapia Co., Ltd.
2015-01-12
Number 730-1-ND
Chongqing Shenghuaxi Phar...
China
No.8, Jiangqiao Road, Nan...
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Korea United Pharmaceutical Co., Ltd.
2014-01-20
Number 4843-9-ND(2)
Cipla Limited
India
Plot No. D-7,D-27 MIDC In...
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Alvogen Korea Co., Ltd.
2013-07-12
Number 184-3-ND(1)
F. Hoffmann-La Roche Ltd....
Switzerland
Grenzacherstrasse 124 CH-...
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Jeil Pharmaceutical Co., Ltd.
2013-03-13
Number 184-3-ND
F. Hoffmann-La Roche Ltd....
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Grenzacherstrasse 124 CH-...
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Lihu Healthcare Co., Ltd.
2011-12-09
Number 4766-1-ND
Fleming Laboratories Limi...
India
Plot No. 152&160, Phase-V...
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Chodang Pharmaceutical Industry Co., Ltd.
2013-03-22
Number 4766-1-ND(3)
Fleming Laboratories Limi...
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Plot No. 152&160, Phase-V...
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Theragen Etex Co., Ltd.
2012-04-20
Number 4766-1-ND(1)
Fleming Laboratories Limi...
India
Plot No. 152&160, Phase-V...
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Hiple Co., Ltd.
2020-09-08
Number 4766-1-ND(5)
Fleming Laboratories Limi...
India
Plot No. 152&160, Phase-V...
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Hyundai Pharmaceutical Co., Ltd.
2013-02-19
Number 4766-1-ND(2)
Fleming Laboratories Limi...
India
Plot No. 152&160, Phase-V...
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Unimed Pharmaceutical Co., Ltd.
2016-02-04
Number 4766-1-ND(4)
Fleming Laboratories Limi...
India
Plot No. 152&160, Phase-V...
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Genuine Science Co., Ltd.
2015-01-16
Number 4554-1-ND(4)
Gador S.A.
Argentina
Calle 10, Fraccion Ⅲ, P...
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Shinpoong Pharmaceutical Co., Ltd.
2011-11-04
Number 4554-1-ND(2)
Gador S.A.
Argentina
Calle 10, Fraccion III, P...
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Dongkook Pharmaceutical Co., Ltd.
2014-09-24
Number 4554-1-ND(3)
Gador S.A.
Argentina
Calle 10, Fraccion III, P...
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Goodwills Co., Ltd.
2011-06-15
Number 4554-1-ND
Gador S.A.
Argentina
Calle 10, Fraccion Ⅲ, P...
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Yuyu Pharmaceutical Co., Ltd.
2011-10-07
Number 4554-1-ND(1)
Gador S.A.
Argentina
Calle 10, Fraccion Ⅲ, P...
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Korea United Pharmaceutical Co., Ltd.
2016-08-24
Number 4554-1-ND(7)
Gador. SA
Argentina
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Dongkwang Pharmaceutical Co., Ltd.
2015-12-11
Number 4554-1-ND(6)
Gador S.A.
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Good Pharma Co., Ltd.
2015-11-27
Number 4554-1-ND(5)
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Alvogen Korea Co., Ltd.
2013-03-06
Number 5616-1-ND(1)
NATCO PHARMA LIMITED
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Mekaguda Village, Kothur ...
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ENGCHEM Life Science Co., Ltd.
2011-06-15
Number 5616-1-ND
NATCO PHARMA LIMITED
India
CHEMICAL DIVISION, MEKAGU...
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Handok Co., Ltd.
2005-07-28
Number 184-1-ND
Roche Diagnostics GmbH
Germany
Sandhofer Str. 116 D-6830...
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  • TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 138844-81-2 / Ibandronate Sodium API manufacturers, exporters & distributors?

Ibandronate Sodium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ibandronate Sodium

Synonyms

138844-81-2, Bondronat, Ibandronate sodium salt, Boniva, Ibandronate (sodium), Sodium ibandronate

Cas Number

138844-81-2

Unique Ingredient Identifier (UNII)

23Y0B94E49

About Ibandronate Sodium

Aminobisphosphonate that is a potent inhibitor of BONE RESORPTION. It is used in the treatment of HYPERCALCEMIA associated with malignancy, for the prevention of fracture and bone complications in patients with breast cancer and bone metastases, and for the treatment and prevention of POSTMENOPAUSAL OSTEOPOROSIS.

Ibandronate Sodium Manufacturers

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

Ibandronate Sodium Suppliers

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

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

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

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

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

Ibandronate Sodium Manufacturers | Traders | Suppliers

Ibandronate Sodium 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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