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Chemistry

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Also known as: L-alanine, 56-41-7, (s)-alanine, H-ala-oh, L-alpha-alanine, (s)-2-aminopropanoic acid
Molecular Formula
C3H7NO2
Molecular Weight
89.09  g/mol
InChI Key
QNAYBMKLOCPYGJ-REOHCLBHSA-N
FDA UNII
OF5P57N2ZX

L-Alanine API
A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.
Alanine is an Amino Acid.
1 2D Structure

L-Alanine API

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2-aminopropanoic acid
2.1.2 InChI
InChI=1S/C3H7NO2/c1-2(4)3(5)6/h2H,4H2,1H3,(H,5,6)/t2-/m0/s1
2.1.3 InChI Key
QNAYBMKLOCPYGJ-REOHCLBHSA-N
2.1.4 Canonical SMILES
CC(C(=O)O)N
2.1.5 Isomeric SMILES
C[C@@H](C(=O)O)N
2.2 Other Identifiers
2.2.1 UNII
OF5P57N2ZX
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Abufne

2. Alanine, L Isomer

3. Alanine, L-isomer

4. L Alanine

5. L-alanine

6. L-isomer Alanine

2.3.2 Depositor-Supplied Synonyms

1. L-alanine

2. 56-41-7

3. (s)-alanine

4. H-ala-oh

5. L-alpha-alanine

6. (s)-2-aminopropanoic Acid

7. L-2-aminopropionic Acid

8. (2s)-2-aminopropanoic Acid

9. L-(+)-alanine

10. L-2-aminopropanoic Acid

11. 2-aminopropionic Acid

12. Alpha-alanine

13. L-alpha-aminopropionic Acid

14. Alpha-aminopropionic Acid

15. L-2-aminopropionsaeure

16. Alaninum [latin]

17. (s)-(+)-alanine

18. L-s-aminopropionic Acid

19. (l)-alanine

20. Alanine (van)

21. (s)-2-aminopropionsaeure

22. Poly-l-alanine

23. 2-aminopropanoic Acid, L-

24. (s)-alpha-aminopropionsaeure

25. Alanine [usan:inn]

26. Alanina [dcit,spanish]

27. Alanine, L-

28. L-alanine, Homopolymer

29. L-a-aminopropionic Acid

30. L-alanin

31. (s)-2-aminopropionic Acid

32. Propanoic Acid, 2-amino-, (s)-

33. 25191-17-7

34. Hsdb 1801

35. Nsc 206315

36. L-alanine Homopolymer

37. Mfcd00064410

38. Of5p57n2zx

39. Chembl279597

40. Chebi:16977

41. Alanine (l-alanine)

42. Polyalanine

43. Alaninum

44. A-alanine

45. Poly-dl-alanine

46. L-a-alanine

47. 14c-l-alanine

48. A-aminopropionic Acid

49. (2s)-2-aminopropanoate

50. (c14)l-alanine

51. .alpha.-alanine

52. 18875-37-1

53. L-.alpha.-alanine

54. L-&alpha-alanine

55. Alanine (usp)

56. L-alanine (9ci)

57. 2-ammoniopropanoate

58. Propanoic Acid, 2-amino-

59. .alpha.-aminopropionic Acid

60. L-alanine, N-coco Alkyl Derivs.

61. L-alanine, Labeled With Carbon-14

62. Einecs 200-273-8

63. L-.alpha.-aminopropionic Acid

64. Unii-of5p57n2zx

65. Ritalanine

66. Racemic Alanine

67. A-aminopropionate

68. L-alanine, Labeled With Tritium

69. 3h-l-alanine

70. L-alanine Powder

71. Propanoic Acid, 2-amino-, (s)

72. [3h]alanine

73. L-a-aminopropionate

74. L-ala

75. [14c]alanine

76. [3h]-alanine

77. Alpha-aminopropanoate

78. Alpha-aminopropionate

79. L-2-aminopropanoate

80. L-2-aminopropionate

81. L-alanine,(s)

82. [14c]-alanine

83. L-alpha-aminopropionate

84. Tocris-0205

85. 2-ammoniopropanoic Acid

86. Ala-oh

87. Starbld0003382

88. L-alanine (jp17)

89. (s)-2-aminopropanoate

90. Alanine [vandf]

91. Alanine [hsdb]

92. Alanine [inci]

93. Alanine [usan]

94. Alanine [inn]

95. Alpha-aminopropanoic Acid

96. Alanine [ii]

97. Alanine [mi]

98. L-ala-2

99. L-alanine [fcc]

100. L-alanine [jan]

101. (s)-2-amino-propanoate

102. Alanine [who-dd]

103. L-alanine, >=99%

104. Bmse000028

105. Bmse000994

106. Ec 200-273-8

107. L-ch3ch(nh2)cooh

108. L-alanine [usp-rs]

109. Gtpl720

110. (s)-2-amino-propanoic Acid

111. 26336-61-8

112. (2s)-2-azanylpropanoic Acid

113. Alanine [ep Monograph]

114. Alanine, L- (7ci,8ci)

115. Gtpl4542

116. Gtpl4543

117. Alanine [usp Monograph]

118. Dtxsid20873899

119. L-alanine, >=98% (tlc)

120. L-alanine, 99%, Natural, Fg

121. F4f207ff-8ff8-4789-99a1-147ae0a36673

122. Hy-n0229

123. Str01663

124. Zinc4658553

125. L-alanine, >=99.0% (nt)

126. Ac-014

127. Bdbm50000099

128. S5631

129. (s)-2-aminopropanoic Acid;h-ala-oh

130. Akos010367904

131. Akos015840030

132. Ccg-266017

133. Cs-w020002

134. Db00160

135. L-alanine, Purum, >=98.0% (nt)

136. Serine Impurity A [ep Impurity]

137. Valine Impurity A [ep Impurity]

138. Ncgc00024494-01

139. 130380-93-7

140. 6898-94-8

141. Ac-24031

142. Bp-13281

143. L-alanine, Bioultra, >=99.5% (nt)

144. Db-029940

145. L-alanine, Saj Special Grade, >=99.0%

146. A0179

147. Am20100374

148. A15652

149. C00041

150. D00012

151. D84362

152. Lysine Acetate Impurity C [ep Impurity]

153. L-alanine, Cell Culture Reagent (h-l-ala-oh)

154. 064a410

155. A803529

156. Q218642

157. Sr-01000597687

158. J-015860

159. Q-201274

160. Sr-01000597687-3

161. L-alanine, Certified Reference Material, Tracecert(r)

162. Alanine, European Pharmacopoeia (ep) Reference Standard

163. F0001-2354

164. Z940713326

165. L-alanine, United States Pharmacopeia (usp) Reference Standard

166. L-alanine, Pharmaceutical Secondary Standard; Certified Reference Material

167. 115967-49-2

168. 77160-91-9

169. L-alanine, From Non-animal Source, Meets Ep, Usp Testing Specifications, Suitable For Cell Culture, >=98.5%

170. L-alanine, Pharmagrade, Ajinomoto, Ep, Jp, Usp, Manufactured Under Appropriate Gmp Controls For Pharma Or Biopharmaceutical Production, Suitable For Cell Culture

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 89.09 g/mol
Molecular Formula C3H7NO2
XLogP3-3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count3
Rotatable Bond Count1
Exact Mass89.047678466 g/mol
Monoisotopic Mass89.047678466 g/mol
Topological Polar Surface Area63.3 Ų
Heavy Atom Count6
Formal Charge0
Complexity61.8
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Therapeutic Uses

Exptl Ther: ... Therapy of acute water diarrhea is reported in 94 male patients, aged 6-59 yr, of whom 49 were given a standard dextrose (glucose) based formula, to a total dose of 105-1719 ml/kg, and 45 were given the same soln with added alanine 90 uM/l, to a total dose of 60-1035 ml/kg. All patients were also given iv injections of replacement soln and oral tetracycline. The median stool output/kg body weight during the initial 24 hr of treatment until diarrhea stopped was reduced in those given the soln containing alanine as compared to controls. Intake of oral rehydration soln was reduced in those given alanine. Two patients given alanine soln and 18 given the standard treatment required unscheduled rapid iv replacement soln to correct signs of dehydration during oral therapy.

Patra FC et al; Br Med J 298: 1353-6 (1989)


DIETARY SUPPLEMENT

Lewis, R.J., Sr (Ed.). Hawley's Condensed Chemical Dictionary. 12th ed. New York, NY: Van Nostrand Rheinhold Co., 1993, p. 29


Used in pharmaceutical preparations for injection or infusion; dietary supplement and flavor compounds in maillard reaction products; stimulant of glucagon secretion

Gerhartz, W. (exec ed.). Ullmann's Encyclopedia of Industrial Chemistry. 5th ed.Vol A1: Deerfield Beach, FL: VCH Publishers, 1985 to Present., p. VA2 80-4


4.2 Drug Indication

Used for protein synthesis.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Is an important source of energy for muscle tissue, the brain and central nervous system; strengthens the immune system by producing antibodies; helps in the metabolism of sugars and organic acids.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
ALANINE
5.2.2 FDA UNII
OF5P57N2ZX
5.2.3 Pharmacological Classes
Chemical Structure [CS] - Amino Acids
5.3 Mechanism of Action

L-Alanine is a non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases immunity, and provides energy for muscle tissue, brain, and the central nervous system. BCAAs are used as a source of energy for muscle cells. During prolonged exercise, BCAAs are released from skeletal muscles and their carbon backbones are used as fuel, while their nitrogen portion is used to form another amino acid, Alanine. Alanine is then converted to Glucose by the liver. This form of energy production is called the Alanine-Glucose cycle, and it plays a major role in maintaining the body's blood sugar balance.


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Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 250, 64293 Darm stadt,(BENEFICIARY MERCKFINANCIALS SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1768933800,"product":"D12492 RD WITH 60 KCAL% WITH ADDED ALANINE (FOR RESEARCH USE)RDI","address":"FLAT-613-A-6,","city":"NEW DELHI","supplier":"RESEARCH DIETS INC","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"BTL BIOTECHNO LABS PRIVATE LTD","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"37.6","totalValueFC":"11330.6","currency":"N\/A","unitRateINR":"3427","date":"21-Jan-2026","totalValueINR":"1028091.99","totalValueInUsd":"11330.6","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"20 JULES LANE NEW BRUNSWICK NJ 8901 SDNF SDNF","customerAddress":"FLAT-613-A-6,"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1769020200,"product":"N-[1-(S)-ETHOXYCARBONYL-3-PHENYLPROPYL]-L-ALANINE N-[1-(S)-ETHOXYCARBONYL-3-PHENYLPROPYL]-L-ALANINE","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"ALIVUS LIFE SCIENCES LTD","customerCountry":"INDIA","quantity":"130.00","actualQuantity":"130","unit":"KGS","unitRateFc":"130","totalValueFC":"16986.4","currency":"N\/A","unitRateINR":"11856","date":"22-Jan-2026","totalValueINR":"1541280","totalValueInUsd":"16986.4","indian_port":"Bombay Air","hs_no":"29159099","bill_no":"29","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG, 317024, CHINA SDNF China","customerAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1769538600,"product":"N-[(S)-(2,3,4,5,6-PENTAFLUOROPHENOXY)PHENOXYPHOSPHINYL]-L-ALANINE 1-METHYLETHYL ESTERFR179642 MICAFUNGIN MAIN CHAIN","address":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL","city":"HYDERABAD, AP","supplier":"JIANGSU COBEN PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"MSN LIFE SCIENCES PRIVATE LTD","customerCountry":"INDIA","quantity":"66.00","actualQuantity":"66","unit":"KGS","unitRateFc":"110","totalValueFC":"7297.1","currency":"N\/A","unitRateINR":"10032","date":"28-Jan-2026","totalValueINR":"662112","totalValueInUsd":"7297.1","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"3","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.168 SHANGHAI ROAD, QIDONG LIFE AND HEALTH INDUSTRIAL PARK, JIANGSU PROVINCE, CHINA CN","customerAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1770143400,"product":"L-PHENYLALANINE EMPROVE EXPERT PH EUR,JP,USP 1PCS X 1KG (P HARMA GRADE)","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"CHINA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK LIFE SCIENCE PRIVATE LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"605.1","totalValueFC":"607.9","currency":"INR","unitRateINR":"55180.7","date":"04-Feb-2026","totalValueINR":"55180.72","totalValueInUsd":"607.9","indian_port":"Bombay 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Air","hs_no":"29224990","bill_no":"582","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 250, 64293 Darm stadt,(BENEFICIARY MERCKFINANCIALS SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1770316200,"product":"L-ALANINE ISOPROPYL ESTER HYDROCHLORIDE","address":"KALPATARU INSPIRE 3RD FLOOR, ,? OFF. W.E. HIGHWAY, SANTACRUZ (EAST) ,? MUMBAI , ?MUMBAI SUBURBAN ,? MAHARASHTRA,? 400055","city":"","supplier":"SICHUAN TONGSHENG BIOPHARMACEUTIAL CO LTD","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"LUPIN MANUFACTURING SOLUTIONS LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"29","totalValueFC":"29185.7","currency":"USD","unitRateINR":"2649.2","date":"06-Feb-2026","totalValueINR":"2649150","totalValueInUsd":"29185.7","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"7069","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHENGDU","supplierAddress":"WUMIAO VILLAGE, TIANYUAN DEVELOPMEN T ZONE, DEYANG, SICHUAN, CHINA 6180 0 China","customerAddress":"KALPATARU INSPIRE 3RD FLOOR, ,? OFF. W.E. HIGHWAY, SANTACRUZ (EAST) ,? MUMBAI , ?MUMBAI SUBURBAN ,? MAHARASHTRA,? 400055"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1770402600,"product":"(ALPHAS)-ALPHA-[(4-MORPHOLINYLACETYL)AMINO]BENZE NEBUTANOYL- L-LEUCYL-L-PHENYLALANINE","address":"43-11-56, SUBBALAKSHMI NAGAR","city":"VISAKHAPATNAM, A.P.","supplier":"UBERONE LLC","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"SIONC PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"14600","totalValueFC":"14693.5","currency":"USD","unitRateINR":"1333710","date":"07-Feb-2026","totalValueINR":"1333710","totalValueInUsd":"14693.5","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"14","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"9TH FLOOR, 1#, NO.98 CHUANGYUAN RD, SMART PARK, HI-TECH ZONE, NINGBO CN","customerAddress":"43-11-56, SUBBALAKSHMI NAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1770402600,"product":"SAMPLE FOR TESTING OF (ALPHAS)-ALPHA-[(4-MORPHOLINYLACETYL)A MINO]BENZE NEBUTANOYL-L-LEUCYL-L-PHENYLALANINE","address":"43-11-56, SUBBALAKSHMI NAGAR","city":"VISAKHAPATNAM, A.P.","supplier":"UBERONE LLC","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"SIONC PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"0","totalValueFC":"0","currency":"USD","unitRateINR":"1","date":"07-Feb-2026","totalValueINR":"0.01","totalValueInUsd":"0","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"14","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"9TH FLOOR, 1#, NO.98 CHUANGYUAN RD, SMART PARK, HI-TECH ZONE, NINGBO CN","customerAddress":"43-11-56, SUBBALAKSHMI NAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1771180200,"product":"FMOC-4-[2-BOC-AMINO)ETHOXY]-L-PHENYLALANINE","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"NINHUA RESOURCES CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"70.00","actualQuantity":"70","unit":"KGS","unitRateFc":"1000","totalValueFC":"70448.2","currency":"USD","unitRateINR":"91350","date":"16-Feb-2026","totalValueINR":"6394500","totalValueInUsd":"70448.2","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"65095998","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"21 JIANGXIA ST., NINGBO 315000 P.R . 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25-Feb-2026
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ABOUT THIS PAGE

Looking for 56-41-7 / L-Alanine API API manufacturers, exporters & distributors?

L-Alanine API manufacturers, exporters & distributors 1

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PharmaCompass offers a list of L-Alanine API 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 L-Alanine API manufacturer or L-Alanine API supplier for your needs.

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

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

API | Excipient name

L-Alanine API

Synonyms

L-alanine, 56-41-7, (s)-alanine, H-ala-oh, L-alpha-alanine, (s)-2-aminopropanoic acid

Cas Number

56-41-7

Unique Ingredient Identifier (UNII)

OF5P57N2ZX

About L-Alanine API

A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.

170805-71-7 Manufacturers

A 170805-71-7 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 170805-71-7, including repackagers and relabelers. The FDA regulates 170805-71-7 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 170805-71-7 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 170805-71-7 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

170805-71-7 Suppliers

A 170805-71-7 supplier is an individual or a company that provides 170805-71-7 active pharmaceutical ingredient (API) or 170805-71-7 finished formulations upon request. The 170805-71-7 suppliers may include 170805-71-7 API manufacturers, exporters, distributors and traders.

click here to find a list of 170805-71-7 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

170805-71-7 USDMF

A 170805-71-7 DMF (Drug Master File) is a document detailing the whole manufacturing process of 170805-71-7 active pharmaceutical ingredient (API) in detail. Different forms of 170805-71-7 DMFs exist exist since differing nations have different regulations, such as 170805-71-7 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 170805-71-7 DMF submitted to regulatory agencies in the US is known as a USDMF. 170805-71-7 USDMF includes data on 170805-71-7's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 170805-71-7 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 170805-71-7 suppliers with USDMF on PharmaCompass.

170805-71-7 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The 170805-71-7 Drug Master File in Japan (170805-71-7 JDMF) empowers 170805-71-7 API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the 170805-71-7 JDMF during the approval evaluation for pharmaceutical products. At the time of 170805-71-7 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of 170805-71-7 suppliers with JDMF on PharmaCompass.

170805-71-7 CEP

A 170805-71-7 CEP of the European Pharmacopoeia monograph is often referred to as a 170805-71-7 Certificate of Suitability (COS). The purpose of a 170805-71-7 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 170805-71-7 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 170805-71-7 to their clients by showing that a 170805-71-7 CEP has been issued for it. The manufacturer submits a 170805-71-7 CEP (COS) as part of the market authorization procedure, and it takes on the role of a 170805-71-7 CEP holder for the record. Additionally, the data presented in the 170805-71-7 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 170805-71-7 DMF.

A 170805-71-7 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 170805-71-7 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of 170805-71-7 suppliers with CEP (COS) on PharmaCompass.

170805-71-7 NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing 170805-71-7 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 170805-71-7 API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture 170805-71-7 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain 170805-71-7 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 170805-71-7 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 170805-71-7 suppliers with NDC on PharmaCompass.

170805-71-7 GMP

170805-71-7 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of 170805-71-7 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right 170805-71-7 GMP manufacturer or 170805-71-7 GMP API supplier for your needs.

170805-71-7 CoA

A 170805-71-7 CoA (Certificate of Analysis) is a formal document that attests to 170805-71-7's compliance with 170805-71-7 specifications and serves as a tool for batch-level quality control.

170805-71-7 CoA mostly includes findings from lab analyses of a specific batch. For each 170805-71-7 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

170805-71-7 may be tested according to a variety of international standards, such as European Pharmacopoeia (170805-71-7 EP), 170805-71-7 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (170805-71-7 USP).

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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