Chynops Pharma Pregabalin Chynops Pharma Pregabalin

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

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2022-01-10
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2017-04-03
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2017-04-03
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  • TABLET, EXTENDED RELEASE;ORAL - 165MG
  • TABLET, EXTENDED RELEASE;ORAL - 330MG
  • TABLET, EXTENDED RELEASE;ORAL - 82.5MG
  • CAPSULE;ORAL - 100MG
  • CAPSULE;ORAL - 150MG
  • CAPSULE;ORAL - 200MG
  • CAPSULE;ORAL - 225MG
  • CAPSULE;ORAL - 25MG
  • CAPSULE;ORAL - 300MG
  • CAPSULE;ORAL - 50MG
  • CAPSULE;ORAL - 75MG

Looking for 148553-50-8 / Pregabalin API manufacturers, exporters & distributors?

Pregabalin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Pregabalin

Synonyms

148553-50-8, Lyrica, (s)-3-(aminomethyl)-5-methylhexanoic acid, 3-isobutyl gaba, (3s)-3-(aminomethyl)-5-methylhexanoic acid, Ci-1008

Cas Number

148553-50-8

Unique Ingredient Identifier (UNII)

55JG375S6M

About Pregabalin

A gamma-aminobutyric acid (GABA) derivative that functions as a CALCIUM CHANNEL BLOCKER and is used as an ANTICONVULSANT as well as an ANTI-ANXIETY AGENT. It is also used as an ANALGESIC in the treatment of NEUROPATHIC PAIN and FIBROMYALGIA.

Pregabalin Manufacturers

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

Pregabalin Suppliers

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

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

Pregabalin KDMF

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

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

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

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

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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