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Chynops Pharma Pregabalin Chynops Pharma Pregabalin

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

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01 Dr. Reddy's Laboratories (2)

02 Alembic Pharmaceuticals Limited (1)

03 Almelo (1)

04 Anjan Drug Private Limited (1)

05 Aurisco Pharmaceutical (1)

06 Aurobindo Pharma Limited (1)

07 CTX Lifesciences (1)

08 Changzhou Pharmaceutical Factory (1)

09 Cipla (1)

10 Divis Laboratories (2)

11 Glenmark Life Sciences (1)

12 Hetero Drugs (1)

13 Hikal (2)

14 Huanggang LUBAN Pharmaceutical Co., Ltd. (1)

15 Innovare Labs (1)

16 Intas Pharmaceuticals (2)

17 Kopran (2)

18 LONZEAL PHARMACEUTICALS CO LTD (1)

19 Laboratorio Chimico Internazionale Spa (1)

20 Laurus Labs (1)

21 Lupin Ltd (2)

22 MSN Laboratories (3)

23 Macleods Pharmaceuticals Limited (1)

24 Optimus Pharma (2)

25 Piramal Pharma Solutions (1)

26 Solara Active Pharma Sciences (1)

27 Srini Pharmaceuticals (1)

28 Sun Pharmaceutical Industries Limited (1)

29 Teva API (2)

30 Vasudha Pharma Chem (1)

31 Viatris (3)

32 Wanbury Limited (1)

33 Zhejiang Apeloa Jiayuan Pharmaceutical (1)

34 Zhejiang Bamboo Pharmaceuticals (1)

35 Zhejiang Huahai Pharmaceutical (1)

36 Zhejiang Jiuzhou Pharmaceutical (1)

37 Zydus Lifesciences (3)

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01 (S)-PREGABALIN (1)

02 3-(2-AMINO-2-OXOETHYL)-5-METHYLHEXANOIC ACID (1)

03 PREGABALIN (19)

04 PREGABALIN (ALTERNATIVE PROCESS) (1)

05 PREGABALIN (PROCESS II) (1)

06 PREGABALIN (PROCESS-B) USP (1)

07 PREGABALIN (PROCESS-II) (1)

08 PREGABALIN (ROUTE CODE - "OP-PGN") (1)

09 PREGABALIN D9333 (1)

10 PREGABALIN DRUG SUBSTANCE (1)

11 PREGABALIN USP (16)

12 PREGABALIN USP (NON-STERILE DRUG SUBSTANCE) (1)

13 PREGABALIN USP (PGC ROUTE) (1)

14 PREGABALIN USP (PROCESS II) (1)

15 PREGABALIN USP (PROCESS-II) (1)

16 PREGABALIN USP [ROUTE CODE - "PU"] (1)

17 PREGABALIN USP [ROUTE CODE - PB"] (1)

18 PREGBALIN USP (1)

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01 China (8)

02 India (36)

03 Israel (2)

04 Italy (1)

05 U.S.A (4)

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01 Active (43)

02 Inactive (8)

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01 Complete (29)

02 Blank (22)

URL Supplier Web Content
24292
Active
2010-09-30
Complete
2015-02-06
2015-01-29
II
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URL Supplier Web Content
22223
Active
2008-11-24
Complete
2013-10-07
2013-09-27
II
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URL Supplier Web Content
24196
Active
2010-09-21
N/A
II
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URL Supplier Web Content
22330
Active
2008-12-17
N/A
II
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URL Supplier Web Content
22111
Active
2008-10-23
Complete
2017-10-27
2017-10-06
II
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URL Supplier Web Content
22128
Active
2008-11-27
N/A
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URL Supplier Web Content
22242
Active
2008-12-01
Complete
2012-11-23
2012-11-13
II
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URL Supplier Web Content
22485
Active
2009-02-03
Complete
2016-04-01
2016-03-24
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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 USDMF

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

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

click here to find a list of Pregabalin suppliers with USDMF 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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