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

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Ace Biopharm Co., Ltd.
2023-04-06
20230406-210-J-1291
Apothecon Pharmaceuticals...
India
Plot No. 1134, 1135, 1136...
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Fresenius Kavi Korea Co., Ltd.
2022-05-04
20220504-210-J-1286
Fresenius Kabi Oncology L...
India
D-35, Industrial Area, Ka...
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Inseong Trading Co., Ltd.
2020-09-15
20200915-210-J-543
Qilu Pharmaceutical Co., ...
China
No. 23999 Gong Ye Bei Roa...
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Hiple Co., Ltd.
2021-03-12
20200818-210-J-676(1)
Shandong Anhong Pharmaceu...
China
No.29 Huayuan Street Liny...
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Inseong Trading Co., Ltd.
2020-08-18
20200818-210-J-676
Shandong Anhong Pharmaceu...
China
No.29 Huayuan street Liny...
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  • SOLUTION;INJECTION - 100MG/10ML (10MG/ML)
  • SOLUTION;INJECTION - 100MG/20ML (5MG/ML)
  • SOLUTION;INJECTION - 150MG/30ML (5MG/ML)
  • SOLUTION;INJECTION - 150MG/20ML (7.5MG/ML)
  • SOLUTION;INJECTION - 1GM/200ML (5MG/ML)
  • SOLUTION;INJECTION - 200MG/20ML (10MG/ML)
  • SOLUTION;INJECTION - 200MG/100ML (2MG/ML)
  • SOLUTION;INJECTION - 20MG/10ML (2MG/ML)
  • SOLUTION;INJECTION - 400MG/200ML (2MG/ML)
  • SOLUTION;INJECTION - 40MG/20ML (2MG/ML)
  • SOLUTION;INJECTION - 500MG/100ML (5MG/ML)
  • SOLUTION;INJECTION - 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;INJECTION - 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 84057-95-4 / Ropivacaine Hydrochloride API manufacturers, exporters & distributors?

Ropivacaine Hydrochloride manufacturers, exporters & distributors 1

40

PharmaCompass offers a list of Ropivacaine Hydrochloride 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 Ropivacaine Hydrochloride manufacturer or Ropivacaine Hydrochloride supplier for your needs.

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

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

API | Excipient name

Ropivacaine Hydrochloride

Synonyms

84057-95-4, (s)-ropivacaine, Naropin, Ropivacaine [inn], Ropivacaina, Ropivacainum

Cas Number

84057-95-4

Unique Ingredient Identifier (UNII)

7IO5LYA57N

About Ropivacaine Hydrochloride

An anilide used as a long-acting local anesthetic. It has a differential blocking effect on sensory and motor neurons.

Ropivacaine Manufacturers

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

Ropivacaine Suppliers

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

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

Ropivacaine KDMF

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

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

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

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

Ropivacaine Manufacturers | Traders | Suppliers

Ropivacaine Manufacturers, Traders, Suppliers 1
17

We have 4 companies offering Ropivacaine

Get in contact with the supplier of your choice:

  1. Apothecon Pharmaceuticals
  2. Fresenius Kabi AB Brunna
  3. Qilu Antibiotics Pharmaceutical Co., Ltd.
  4. Shandong Anhong Pharmaceutical
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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