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List of Drug Master Files (DMF) of Buprenorphine Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Noramco (2)

02 Veranova (1)

03 Sun Pharmaceutical Industries Limited (1)

04 Teva API (1)

05 Arevipharma (1)

06 Fujifilm Diosynth Biotechnologies (1)

07 Mallinckrodt Pharmaceuticals (1)

08 Siegfried AG (2)

09 Tasmanian Alkaloids Pty Ltd (2)

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01 BUPRENORPHINE (7)

02 BUPRENORPHINE BASE (2)

03 BUPRENORPHINE BASE (R371605) DRUG SUBSTANCE (1)

04 BUPRENORPHINE BASE DRUG SUBSTANCE (1)

05 BUPRENORPHINE BASE EP, CODE 3205 (1)

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01 Australia (2)

02 Germany (1)

03 India (1)

04 Ireland (1)

05 Israel (1)

06 Switzerland (2)

07 U.S.A (3)

08 United Kingdom (1)

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01 Active (9)

02 Inactive (3)

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01 Complete (9)

02 Blank (3)

URL Supplier Web Content
33097
Active
2019-03-18
Complete
2019-05-13
2019-04-02
II
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URL Supplier Web Content
28075
Active
2014-03-06
Complete
2015-02-25
2014-04-29
II
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URL Supplier Web Content
27547
Active
2013-09-23
Complete
2014-06-23
2013-09-30
II
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URL Supplier Web Content
8542
Inactive
1990-04-27
N/A
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URL Supplier Web Content
24928
Active
2012-05-02
Complete
2014-01-24
2012-11-27
II
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URL Supplier Web Content
26052
Active
2012-05-14
Complete
2014-05-16
2013-01-28
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URL Supplier Web Content
29091
Active
2015-03-02
Complete
2015-07-24
2015-03-06
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Looking for 52485-79-7 / Buprenorphine API manufacturers, exporters & distributors?

Buprenorphine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Buprenorphine

Synonyms

Temgesic, Probuphine, Buprenex, 52485-79-7, Buprenophine, Buprenorfina

Cas Number

52485-79-7

Unique Ingredient Identifier (UNII)

40D3SCR4GZ

About Buprenorphine

A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.

Buprenorphine Manufacturers

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

Buprenorphine Suppliers

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

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

Buprenorphine USDMF

A Buprenorphine DMF (Drug Master File) is a document detailing the whole manufacturing process of Buprenorphine active pharmaceutical ingredient (API) in detail. Different forms of Buprenorphine DMFs exist exist since differing nations have different regulations, such as Buprenorphine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Buprenorphine DMF submitted to regulatory agencies in the US is known as a USDMF. Buprenorphine USDMF includes data on Buprenorphine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Buprenorphine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Buprenorphine suppliers with USDMF on PharmaCompass.

Buprenorphine Manufacturers | Traders | Suppliers

Buprenorphine Manufacturers, Traders, Suppliers 1
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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