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

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01 Biophore India Pharmaceuticals Pvt Ltd (1)

02 Asymchem Laboratories (1)

03 Dipharma (1)

04 Dipharma SA (1)

05 HONOUR LAB LTD (1)

06 Innopharmax (1)

07 Shiratori Pharmaceutical (1)

08 Solara Active Pharma Sciences (1)

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01 SAPROPTERIN (1)

02 SAPROPTERIN DIHYDROCHLORIDE (5)

03 SAPROPTERIN DIHYDROCHLORIDE (NEW PROCESS) (1)

04 SAPROPTERIN HYDROCHLORIDE DRUG SUBSTANCE (1)

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01 India (3)

02 Italy (1)

03 Japan (1)

04 Switzerland (1)

05 Taiwan (1)

06 U.S.A (1)

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01 Active (7)

02 Inactive (1)

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01 Complete (6)

02 Blank (2)

URL Supplier Web Content
28416
Active
2014-06-20
N/A
II
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URL Supplier Web Content
26682
Active
2012-12-06
Complete
2014-03-04
2013-09-23
II
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URL Supplier Web Content
34926
Active
2020-06-17
Complete
2020-08-26
2020-06-15
II
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URL Supplier Web Content
33928
Active
2019-08-06
Complete
2019-09-20
2019-07-26
II
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URL Supplier Web Content
33553
Active
2019-02-19
Complete
2020-06-23
2019-03-22
II
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URL Supplier Web Content
17569
Inactive
2004-07-20
N/A
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URL Supplier Web Content
34185
Active
2019-10-03
Complete
2020-03-13
2019-12-13
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Looking for / Sapropterin Hydrochloride API manufacturers, exporters & distributors?

Sapropterin Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Sapropterin Hydrochloride

Sapropterin HCl Manufacturers

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

Sapropterin HCl Suppliers

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

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

Sapropterin HCl USDMF

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

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

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

Sapropterin HCl Manufacturers | Traders | Suppliers

Sapropterin HCl Manufacturers, Traders, Suppliers 1
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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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