Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Bachem AG
03 1Nuray Chemicals Private Limited
04 1HRV Global Life Sciences
05 1Omgene Life Sciences Pvt. Ltd
06 1TAPI Technology & API Services
07 1Alven Laboratories
08 1Amino Chemicals
09 1Anhui Biochem Pharmaceutical
10 1Anthem Biosciences
11 1Danesh Kimia Pharmed
12 1Dipharma SA
13 1Hetero Drugs
14 1Saurav Chemicals
15 1Sionc Pharmaceuticals
16 1Suven Pharmaceuticals
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01 1China
02 1Czech Republic
03 9India
04 1Iran
05 1Israel
06 1Malta
07 2Switzerland
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01 4Active
02 1Inactive
03 11Blank
01 16Blank
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01 16Blank
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01 1WC-0171Amendment
02 1WC-0273
03 1WC-0416
04 13Blank
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01 16Blank
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01 143235-0016
02 155463-0034
03 158159-037
04 166005-0046
05 168022-7058
06 176055-0043
07 176438-004
08 9Blank
01 16Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-28
Pay. Date : 2020-08-06
DMF Number : 33948
Submission : 2019-07-17
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
NDC Package Code : 55463-0034
Start Marketing Date : 2004-08-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-01
Pay. Date : 2016-12-26
DMF Number : 31250
Submission : 2017-01-02
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-037
Start Marketing Date : 2024-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30680
Submission : 2016-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35810
Submission : 2021-03-31
Status : Active
Type : II
Date of Issue : 2021-09-17
Valid Till : 2022-08-13
Written Confirmation Number : WC-0171Amendment
Address of the Firm :
NDC Package Code : 43235-0016
Start Marketing Date : 2020-03-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-21
Pay. Date : 2021-08-02
DMF Number : 36026
Submission : 2021-07-31
Status : Active
Type : II
Date of Issue : 2020-07-23
Valid Till : 2023-05-11
Written Confirmation Number : WC-0273
Address of the Firm :
NDC Package Code : 76055-0043
Start Marketing Date : 2019-07-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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PharmaCompass offers a list of Nitisinone 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 Nitisinone manufacturer or Nitisinone supplier for your needs.
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PharmaCompass also assists you with knowing the Nitisinone API Price utilized in the formulation of products. Nitisinone API Price is not always fixed or binding as the Nitisinone Price is obtained through a variety of data sources. The Nitisinone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nitisinone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitisinone, including repackagers and relabelers. The FDA regulates Nitisinone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitisinone 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 Nitisinone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nitisinone supplier is an individual or a company that provides Nitisinone active pharmaceutical ingredient (API) or Nitisinone finished formulations upon request. The Nitisinone suppliers may include Nitisinone API manufacturers, exporters, distributors and traders.
click here to find a list of Nitisinone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 16 companies offering Nitisinone
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