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

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01 JSC Olainfarm (1)

02 Dr. Reddy's Laboratories (1)

03 Megafine Pharma (P) Limited (1)

04 Alembic Pharmaceuticals Limited (1)

05 Amsa Spa (1)

06 Apotex Pharmachem (1)

07 Emcure Pharmaceuticals (1)

08 Esteve Quimica (1)

09 Hainan Poly Pharm (2)

10 Hetero Drugs (1)

11 Hikal (1)

12 Industriale Chimica s.r.l. (1)

13 Lupin Ltd (1)

14 MSN Laboratories (1)

15 Macleods Pharmaceuticals Limited (2)

16 Olon S.p.A (1)

17 Orchid Pharma (1)

18 Procos (1)

19 RANBAXY LABORATORIES LIMITED (1)

20 Sharon Bio-Medicine Limited (1)

21 Sun Pharmaceutical Industries Limited (1)

22 Tai Heng Industry Co., Ltd (1)

23 Teva API (1)

24 Teva Pharmaceutical Industries (1)

25 UQUIFA (1)

26 Unichem Laboratories Limited (1)

27 Viatris (1)

28 ZCL Chemicals Limited (1)

29 Zhejiang Supor Pharmaceuticals Co., LTD (1)

30 Zydus Lifesciences (2)

31 Blank (1)

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01 MEMANTIME HCI (1)

02 MEMANTINE HYDROCHLORIDE (15)

03 MEMANTINE HYDROCHLORIDE 7SM1037 (1)

04 MEMANTINE HYDROCHLORIDE EXTENDED RELEASE PELLETS 28 MG (1)

05 MEMANTINE HYDROCHLORIDE USP (14)

06 MEMANTINE HYDROCHLORIDE USP [ROUTE CODE - MH] (1)

07 MEMANTINE HYDROCHLORIDE, USP (1)

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01 Canada (1)

02 China (4)

03 India (18)

04 Israel (2)

05 Italy (4)

06 Latvia (1)

07 Spain (2)

08 U.S.A (1)

09 Blank (1)

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01 Active (28)

02 Inactive (6)

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01 Complete (21)

02 Blank (13)

20543
Active
2007-05-09
Complete
2013-02-07
2012-11-27
II
JSC OlainFarm Company Banner

Iran Expo

Not Confirmed

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19549
Active
2006-06-20
Complete
2013-06-06
2013-05-22
II
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19465
Active
2006-05-22
Complete
2013-11-21
2013-04-23
II
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20456
Active
2007-03-30
Complete
2014-01-15
2013-12-05
II
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18562
Active
2005-07-29
Complete
2013-06-19
2013-06-05
II
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20848
Active
2007-09-13
N/A
II
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20868
Active
2007-09-20
Complete
2012-11-23
2012-11-09
II
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20362
Active
2007-03-23
Complete
2013-07-23
2013-07-08
II
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Looking for 41100-52-1 / Memantine Hydrochloride API manufacturers, exporters & distributors?

Memantine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Memantine Hydrochloride

Synonyms

41100-52-1, Memantine hcl, Namenda, 3,5-dimethyl-1-adamantanamine hydrochloride, 3,5-dimethyladamantan-1-amine hydrochloride, Akatinol

Cas Number

41100-52-1

Unique Ingredient Identifier (UNII)

JY0WD0UA60

About Memantine Hydrochloride

AMANTADINE derivative that has some dopaminergic effects. It has been proposed as an antiparkinson agent.

Memantine Manufacturers

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

Memantine Suppliers

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

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

Memantine USDMF

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

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

click here to find a list of Memantine 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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