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

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Flag India
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Narsha Farm Co., Ltd.
2020-08-07
20200807-210-J-531
USV Private Limited
India
B-1/8, MIDC Lote Parshura...
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UNUST Co., Ltd.
2021-02-05
20210205-210-J-581
Cipla Limited
India
D-7, MIDC, Industrial Are...
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Leesung International Co., Ltd.
2019-03-14
20190314-210-J-321
Hetero Labs Limited (Unit...
India
Survey No.10, IDA, Gaddap...
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Daewoong Pharmaceutical Co., Ltd.
2019-07-17
20190314-210-J-321(1)
Hetero Labs Limited (Unit...
India
Sy.No.10, IDA, Gaddapotha...
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Otran Farm Korea Co., Ltd.
2022-09-16
20220916-210-J-1363
Shandong New Time Pharmac...
China
No.1, North Outer Ring Ro...
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Samyang Holdings Co., Ltd.
2020-11-19
20200812-210-J-445(1)
Maprimed S.A.
Argentina
Coronel Prudencio Murguio...
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Genuine Science Co., Ltd.
2021-05-11
20200812-210-J-445(2)
Maprimed S.A.
Argentina
Coronel Prudencio Murguio...
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Iksoo Pharmaceutical Co., Ltd.
2020-08-12
20200812-210-J-445
Maprimed S.A.
Argentina
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  • INJECTABLE;INTRAVENOUS - EQ 4MG BASE/100ML
  • INJECTABLE;INTRAVENOUS - EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 118072-93-8 / Zoledronic Acid API manufacturers, exporters & distributors?

Zoledronic Acid manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Zoledronic Acid

Synonyms

Zoledronate, 118072-93-8, Zometa, Reclast, Aclasta, (1-hydroxy-2-(1h-imidazol-1-yl)ethane-1,1-diyl)diphosphonic acid

Cas Number

118072-93-8

Unique Ingredient Identifier (UNII)

70HZ18PH24

About Zoledronic Acid

An imidobisphosphonate inhibitor of BONE RESORPTION that is used for the treatment of malignancy-related HYPERCALCEMIA; OSTEITIS DEFORMANS; and OSTEOPOROSIS.

Zoledronic Acid Manufacturers

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

Zoledronic Acid Suppliers

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

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

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

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

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

Zoledronic Acid Manufacturers | Traders | Suppliers

Zoledronic Acid Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Zoledronic Acid

Get in contact with the supplier of your choice:

  1. USV Private Limited
  2. Cipla
  3. Hetero Drugs
  4. Lunan Pharmaceutical
  5. Maprimed S.A.
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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