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

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01 Grunenthal GmbH (1)

02 Janssen Pharmaceuticals, Inc. @[Partial process manufacturer] Janssen Pharmaceutica NV (1)

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01 Korea Janssen Co., Ltd. (2)

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01 Tapentadol hydrochloride (2)

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01 Germany (1)

02 U.S.A (1)

URL Supplier Web Content
Korea Janssen Co., Ltd.
2015-11-11
Number 4945-23-ND
Grunenthal GmbH
Germany
Zieglerstrabe 6, 52078 Aa...
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URL Supplier Web Content
Korea Janssen Co., Ltd.
2014-07-03
Number 4945-19-ND
Janssen Pharmaceuticals, ...
U.S.A
1440 Olympic Drive, Athen...
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Looking for 175591-09-0 / Tapentadol API manufacturers, exporters & distributors?

Tapentadol manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Tapentadol

Synonyms

175591-09-0, Tapentadol hcl, Nucynta, Palexia, Tapentadol (hydrochloride), Nucynta er

Cas Number

175591-09-0

Unique Ingredient Identifier (UNII)

71204KII53

About Tapentadol

An opioid analgesic, MU OPIOID RECEPTOR agonist, and noradrenaline reuptake inhibitor that is used in the treatment of moderate to severe pain, and of pain associated with DIABETIC NEUROPATHIES.

Tapentadol Hydrochloride Manufacturers

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

Tapentadol Hydrochloride Suppliers

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

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

Tapentadol Hydrochloride KDMF

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

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

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

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

Tapentadol Hydrochloride Manufacturers | Traders | Suppliers

Tapentadol Hydrochloride Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Tapentadol Hydrochloride

Get in contact with the supplier of your choice:

  1. Grunenthal
  2. Johnson & Johnson Innovative Medicine
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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