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

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01 Pharmaceutical Works Polpharma S.A. (5)

02 Anek Prayog Pvt Ltd (1)

03 Cadila Pharmaceuticals Limited (1)

04 Gador S.A. (3)

05 M/S. Aurobindo Pharma Limited, Unit-XI (2)

06 MSD International GmbH T/A MSD Ireland (Ballydine) (1)

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01 Ace Biopharm Co., Ltd. (1)

02 Aging Life Science Co., Ltd. (1)

03 Daewon Pharmaceutical Co., Ltd. (1)

04 Farmirae Co., Ltd. (1)

05 Goodwills Co., Ltd. (1)

06 Hwail Pharmaceutical Co., Ltd. (1)

07 Korea Organon Co., Ltd. (1)

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

09 Narsha Farm Co., Ltd. (1)

10 Sungwoo Chemical Co., Ltd. (1)

11 Wooshin Rabotachi Co., Ltd. (1)

12 Youngjin Pharmaceutical Co., Ltd. (1)

13 Yuyu Pharmaceutical Co., Ltd. (1)

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01 Sodium alendronate hydrate (10)

02 Sodium alendronate trihydrate (3)

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01 Argentina (3)

02 India (4)

03 Poland (5)

04 U.S.A (1)

Farmirae Co., Ltd.
2022-04-18
20181023-209-J-116(4)
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
Hwail Pharmaceutical Co., Ltd.
2018-10-23
20181023-209-J-116
Pharmaceutical Works Polp...
Poland
19, Pelplinska Str. 83-20...
Korea United Pharmaceutical Co., Ltd.
2019-08-29
20181023-209-J-116(2)
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
Daewon Pharmaceutical Co., Ltd.
2021-04-27
20181023-209-J-116(3)
Pharmaceutical Works Polp...
Poland
19, Pelplinska Street., 8...
Wooshin Rabotachi Co., Ltd.
2019-08-02
20181023-209-J-116(1)
Pharmaceutical Works Polp...
Poland
19. Pelplinska Str, 83-20...
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Narsha Farm Co., Ltd.
2021-03-31
20210331-209-J-915
Anek Prayog Pvt Ltd
India
57/2 MIDC, Ind Area, Dhat...
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Ace Biopharm Co., Ltd.
2021-08-30
20210323-209-J-897(1)
M/S. Aurobindo Pharma Lim...
India
Survey Nos. 1/22,2/1 to 5...
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Sungwoo Chemical Co., Ltd.
2021-03-23
20210323-209-J-897
M/S. Aurobindo Pharma Lim...
India
Survey Nos. 1/22,2/1 to 5...
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Korea Organon Co., Ltd.
2022-01-05
20220105-209-J-1194
MSD International GmbH T/...
Ireland
Kilsheelan, Clonmel, Co. ...
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Aging Life Science Co., Ltd.
2020-09-04
20200904-209-J-734
Cadila Pharmaceuticals Li...
India
294, GIDC Estate, City : ...
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Looking for 129318-43-0 / Alendronate Sodium API manufacturers, exporters & distributors?

Alendronate Sodium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Alendronate Sodium

Synonyms

129318-43-0, Fosamax, Binosto, Fosamac, Onclast, Monosodium alendronate

Cas Number

129318-43-0

Unique Ingredient Identifier (UNII)

4988K7X26P

About Alendronate Sodium

A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.

Alendronate Manufacturers

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

Alendronate Suppliers

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

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

Alendronate KDMF

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

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

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

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

Alendronate Manufacturers | Traders | Suppliers

Alendronate Manufacturers, Traders, Suppliers 1
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We have 6 companies offering Alendronate

Get in contact with the supplier of your choice:

  1. Polpharma
  2. Anek Prayog Pvt. Ltd.,
  3. Aurobindo Pharma Limited
  4. Gador SA
  5. Merck & Co
  6. Zydus Lifesciences
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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