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1. 2 Hydroxypropanoic Acid
2. 2 Hydroxypropionic Acid
3. 2-hydroxypropanoic Acid
4. 2-hydroxypropionic Acid
5. Ammonium Lactate
6. D Lactic Acid
7. D-lactic Acid
8. L Lactic Acid
9. Lactate
10. Lactate, Ammonium
11. Lactic Acid
12. Propanoic Acid, 2-hydroxy-, (2r)-
13. Propanoic Acid, 2-hydroxy-, (2s)-
14. Sarcolactic Acid
1. 79-33-4
2. L-(+)-lactic Acid
3. (s)-lactic Acid
4. (s)-2-hydroxypropanoic Acid
5. Sarcolactic Acid
6. (s)-2-hydroxypropionic Acid
7. (2s)-2-hydroxypropanoic Acid
8. (+)-lactic Acid
9. (s)-(+)-lactic Acid
10. Paralactic Acid
11. L(+)-lactic Acid
12. Lactic Acid, L-
13. Espiritin
14. Tisulac
15. Purac
16. (s)-lactate
17. L-lactate
18. Propanoic Acid, 2-hydroxy-, (2s)-
19. Sarcolacticum Acidum
20. L-(+)-alpha-hydroxypropionic Acid
21. Ph 90
22. Propanoic Acid, 2-hydroxy-, (s)-
23. F9s9ffu82n
24. Chebi:422
25. Paramilchsaeure
26. (2s)-2-hydroxypropanoic Acid Homopolymer
27. Fleischmilchsaeure
28. (+)-lactate
29. (s)-milchsaeure
30. Propanoic Acid, 2-hydroxy-, (s)-, Homopolymer
31. Acidum Sarcolacticum
32. Pleo Sanvis
33. Mfcd00064266
34. (s)-2-hydroxypropionsaeure
35. 2-hydroxy-propionic Acid
36. Plla
37. Alpha-hydroxypropanoic Acid
38. Einecs 201-196-2
39. Unii-f9s9ffu82n
40. Brn 1720251
41. 1-hydroxyethane 1-carboxylic Acid
42. L(+)-2-hydroxypropionsaeure
43. L-lacticacid
44. L-milchsaeure
45. (alpha)-lactate
46. L-iactic Acid
47. Lactic Acid Fcc
48. A-hydroxypropanoate
49. A-hydroxypropionate
50. 2op
51. Nchembio867-comp9
52. (alpha)-lactic Acid
53. Alpha-hydroxypropanoate
54. Alpha-hydroxypropionate
55. L-2-hydroxypropanoate
56. A-hydroxypropanoic Acid
57. A-hydroxypropionic Acid
58. L-(+) Lactic Acid
59. L-lactic Acid, 90%
60. (s)-2-hydroxypropanoate
61. (s)-2-hydroxypropionate
62. 1-hydroxyethanecarboxylate
63. L-lactic Acid, Anhydrous
64. L-2-hydroxypropanoic Acid
65. Bmse000208
66. Bmse000818
67. Bmse000979
68. (s)-2-hydroxy-propanoate
69. Ec 201-196-2
70. L-lactic Acid [mi]
71. L-lactic Acid [jan]
72. 4-03-00-00633 (beilstein Handbook Reference)
73. L-(+)-lactic Acid Solution
74. 1-hydroxyethane 1-carboxylate
75. (s)-2-hydroxy-propanoic Acid
76. (s)-2-hydroxy-propionic Acid
77. Chembl330546
78. Gtpl2932
79. L- Lactic Acid (+)
80. (s)-(+)-2-hydroxypropanoate
81. L-(+)-lactic Acid, 80%
82. (s)(+)2 Hydroxypropionic Acid
83. Dtxsid6034689
84. Lactic Acid, L- [ii]
85. Dextrorotatory Lactic Acid
86. (s)(+)-2 Hydroxypropionic Acid
87. L-lactic Acid Solution, 90.0%
88. Sarcolactic Acid [who-dd]
89. L-(+)-lactic Acid 95% Liquid
90. 80% (w/w) Lactic Acid Solution
91. L-(+)-lactic Acid Solution, 1m
92. L-(+)-lactic Acid, >=98%
93. Sarcolacticum Acidum [hpus]
94. (s)-(+)-2-hydroxypropanoic Acid
95. 2-hydroxypropanoic Acid, (s)- #
96. Hy-y0479
97. Zinc4658560
98. S6250
99. Akos025146504
100. Db14475
101. L-lactic Acid, Crystalline, 98.0%+
102. (s)-lactic Acid [ep Monograph]
103. L-(+)-lactic Acid, Analytical Standard
104. Cs-0015266
105. Ft-0773848
106. L0165
107. L-(+)-lactic Acid Solution, ~40% In H2o
108. C00186
109. D71144
110. L-0990
111. L-1000
112. L-(+)-lactic Acid Solution, In H2o, >=85%
113. L-(+)-lactic Acid, Bioxtra, >=98% (titration)
114. L-(+)-lactic Acid, Vetec(tm) Reagent Grade, 86%
115. Q27080955
116. 5e39d33d-2f71-4c24-bc7a-5e6f27e4cf83
117. L-(+)-lactic Acid Solution, 30% In H2o (by Weight)
118. L-(+)-lactic Acid Solution, ~50% (l-lactic Acid In Water)
119. L-(+)-lactic Acid Solution, Purum, ~20% (l-lactic Acid In Water)
120. L+lactic Acid, Free Acid (s)-2-hydroxypropionic Acid, Sarcolactic Acid
121. L-(+)-lactic Acid Solution, Acs Reagent, 85-90% (l-lactic Acid In Water)
122. L-(+)-lactic Acid Solution, Purum P.a., 79-81% (l-lactic Acid In Water, T)
123. L-(+)-lactic Acid Solution, Meets Analytical Specification Of Ph.??eur., Bp, 88-92% Total Acid Basis
Molecular Weight | 90.08 g/mol |
---|---|
Molecular Formula | C3H6O3 |
XLogP3 | -0.7 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 3 |
Rotatable Bond Count | 1 |
Exact Mass | 90.031694049 g/mol |
Monoisotopic Mass | 90.031694049 g/mol |
Topological Polar Surface Area | 57.5 Ų |
Heavy Atom Count | 6 |
Formal Charge | 0 |
Complexity | 59.1 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Prevention of pregnancy
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-28
Pay. Date : 2022-09-23
DMF Number : 20726
Submission : 2007-07-26
Status : Active
Type : II
Certificate Number : R1-CEP 2006-124 - Rev 01
Status : Valid
Issue Date : 2023-04-27
Type : Chemical
Substance Number : 1771
NDC Package Code : 57520-1262
Start Marketing Date : 2014-02-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (3g)
Marketing Category : DRUG FOR FURTHER PROCESSING
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Under the licensing agreement, Windtree will hold the exclusive rights of Phexxi (lactic acid, citric acid, and potassium bitartrate) vaginal gel. It is being indicated to prevent prgenancy.
Lead Product(s): L-Lactic Acid,Lactic Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Phexxi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Windtree Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 20, 2025
Lead Product(s) : L-Lactic Acid,Lactic Acid,Potassium Bitartrate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Windtree Therapeutics
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Windtree Signs License & Supply Deal for FDA Approved Small Biotech Product
Details : Under the licensing agreement, Windtree will hold the exclusive rights of Phexxi (lactic acid, citric acid, and potassium bitartrate) vaginal gel. It is being indicated to prevent prgenancy.
Product Name : Phexxi
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
March 20, 2025
Details:
Through the acquisition of Evofem, Aditxt gains access to its first and only FDA-approved hormone-free contraceptive gel, Phexxi (lactic acid, citric acid, and potassium bitartrate).
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Phexxi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Aditxt
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 12, 2023
Lead Product(s) : L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Aditxt
Deal Size : Undisclosed
Deal Type : Acquisition
Details : Through the acquisition of Evofem, Aditxt gains access to its first and only FDA-approved hormone-free contraceptive gel, Phexxi (lactic acid, citric acid, and potassium bitartrate).
Product Name : Phexxi
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
December 12, 2023
Details:
Sculptra is the first and original injectable collagen stimulator containing microparticles of unique poly-L-lactic acid (PLLA-SCA) which gradually revitalizes the skin’s structural foundation.
Lead Product(s): L-Lactic Acid,Carboxymethyl Cellulose
Therapeutic Area: Dermatology Brand Name: Sculptra
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 30, 2023
Lead Product(s) : L-Lactic Acid,Carboxymethyl Cellulose
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
AMWC 2023: Data From Sculptra® Cheek Wrinkle and Alluzience® Star Studies Reinforce Strength of ...
Details : Sculptra is the first and original injectable collagen stimulator containing microparticles of unique poly-L-lactic acid (PLLA-SCA) which gradually revitalizes the skin’s structural foundation.
Product Name : Sculptra
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 30, 2023
Details:
Phexxi® (lactic acid, citric acid, and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel, an on-demand method of birth control used to prevent pregnancy.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Phexxi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 07, 2022
Lead Product(s) : L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Phexxi® Mechanism of Action Article Published in the Journal of Therapeutic Advances in Reproduct...
Details : Phexxi® (lactic acid, citric acid, and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel, an on-demand method of birth control used to prevent pregnancy.
Product Name : Phexxi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 07, 2022
Details:
Initially, Bora will manufacture Phexxi for nations currently considering formal regulatory approval of Phexxi (L-lactic Acid), for the prevention of pregnancy, including Mexico and Nigeria.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Phexxi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Bora Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 05, 2022
Lead Product(s) : L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Bora Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Partnership
Details : Initially, Bora will manufacture Phexxi for nations currently considering formal regulatory approval of Phexxi (L-lactic Acid), for the prevention of pregnancy, including Mexico and Nigeria.
Product Name : Phexxi
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
October 05, 2022
Details:
Phexxi (L-lactic Acid) is a hormone-free, woman-controlled contraceptive gel. It works by maintaining vaginal pH in the optimal range of 3.5 to 4.5, which is inhospitable to sperm, as well as certain bacterial and viral pathogens including chlamydia and gonorrhea.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Phexxi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 23, 2022
Lead Product(s) : L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Evofem Announces Issuance of U.S. Patent Covering Phexxi® Composition of Matter
Details : Phexxi (L-lactic Acid) is a hormone-free, woman-controlled contraceptive gel. It works by maintaining vaginal pH in the optimal range of 3.5 to 4.5, which is inhospitable to sperm, as well as certain bacterial and viral pathogens including chlamydia and ...
Product Name : Phexxi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 23, 2022
Details:
Phexxi (L-lactic Acid) is an on-demand method of birth control used to prevent pregnancy. Phexxi is not effective when used after sex.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Phexxi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 16, 2022
Lead Product(s) : L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Large Commercial Payer Adds Phexxi® to Formulary for Standard Plans Nationwide
Details : Phexxi (L-lactic Acid) is an on-demand method of birth control used to prevent pregnancy. Phexxi is not effective when used after sex.
Product Name : Phexxi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 16, 2022
Details:
Phexxi's (L-lactic Acid) mechanism of action through vaginal pH modulation results in the immobilization of spermatozoa by maintaining the normally low vaginal pH, even in the presence of semen.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Phexxi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 16, 2022
Lead Product(s) : L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Phexxi® Prevented 99% of Pregnancies Per Act of Intercourse in a Post Hoc Analysis of Phase 3 AMP...
Details : Phexxi's (L-lactic Acid) mechanism of action through vaginal pH modulation results in the immobilization of spermatozoa by maintaining the normally low vaginal pH, even in the presence of semen.
Product Name : Phexxi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 16, 2022
Details:
Phexxi® (lactic acid, citric acid and potassium bitartrate) vaginal gel provides women an in-the-moment contraceptive that can be easily applied 0-60 minutes before each act of intercourse and works by maintaining the baseline vaginal pH environment.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Phexxi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 10, 2022
Lead Product(s) : L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Evofem Biosciences Announces Approval of Phexxi in Nigeria
Details : Phexxi® (lactic acid, citric acid and potassium bitartrate) vaginal gel provides women an in-the-moment contraceptive that can be easily applied 0-60 minutes before each act of intercourse and works by maintaining the baseline vaginal pH environment.
Product Name : Phexxi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 10, 2022
Details:
New data from the Phase 3 AMPOWER clinical trial of Phexxi® (lactic acid, citric acid, and potassium bitartrate) showed that women enrolled in the AMPOWER trial had fewer urinary tract infections (UTIs) compared to the general population.
Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Phexxi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 05, 2022
Lead Product(s) : L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : New data from the Phase 3 AMPOWER clinical trial of Phexxi® (lactic acid, citric acid, and potassium bitartrate) showed that women enrolled in the AMPOWER trial had fewer urinary tract infections (UTIs) compared to the general population.
Product Name : Phexxi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 05, 2022
Regulatory Info :
Registration Country : Canada
Brand Name : PEROXY PREP
Dosage Form : SOLUTION
Dosage Strength : 1.7%/W/W
Packaging :
Approval Date :
Application Number : 2484145
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : PRISMASOL 4
Dosage Form : SOLUTION
Dosage Strength : 5.4G/L
Packaging : 250+4750ML CHAMBER BAG
Approval Date :
Application Number : 2277476
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : SANI-CIDE EX3
Dosage Form : SPRAY
Dosage Strength : 0.4%/W/W
Packaging :
Approval Date :
Application Number : 2502844
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : WINDEX MULTI-SURFACE ANTIBACTERIAL DISINFECTANT 2
Dosage Form : SPRAY
Dosage Strength : 0.19%/W/W
Packaging : 300ML TO 5L
Approval Date :
Application Number : 2416883
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : ACTIVE OXY C
Dosage Form : SOLUTION
Dosage Strength : 1.7%/W/W
Packaging : 4L/18.9L/56.8L/208L/1040L
Approval Date :
Application Number : 2481626
Regulatory Info :
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Canada
Brand Name : CDLA-MIX
Dosage Form : SOLUTION
Dosage Strength : 2.64%/W/W
Packaging :
Approval Date :
Application Number : 2518880
Regulatory Info :
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Related Excipient Companies
Excipients by Applications
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
Grade : Oral
Category : Co-Processed Excipients, Fillers, Diluents & Binders
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Taste Masking
Application : Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : CM90 is a directly compressible, granulated calcium carbonate with maltodextrin used for swallow tablets due to its high density and compressibility.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 490- 500 µm; Tapped Density: 1.50
Ingredient(s) : Calcium Carbonate Excipient
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Market Place
ANALYTICAL
ABOUT THIS PAGE
22
PharmaCompass offers a list of L-Lactic Acid 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-Lactic Acid manufacturer or L-Lactic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred L-Lactic Acid manufacturer or L-Lactic Acid supplier.
PharmaCompass also assists you with knowing the L-Lactic Acid API Price utilized in the formulation of products. L-Lactic Acid API Price is not always fixed or binding as the L-Lactic Acid Price is obtained through a variety of data sources. The L-Lactic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A L-Lactic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Lactic Acid, including repackagers and relabelers. The FDA regulates L-Lactic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Lactic Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A L-Lactic Acid supplier is an individual or a company that provides L-Lactic Acid active pharmaceutical ingredient (API) or L-Lactic Acid finished formulations upon request. The L-Lactic Acid suppliers may include L-Lactic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of L-Lactic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Lactic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Lactic Acid active pharmaceutical ingredient (API) in detail. Different forms of L-Lactic Acid DMFs exist exist since differing nations have different regulations, such as L-Lactic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Lactic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. L-Lactic Acid USDMF includes data on L-Lactic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Lactic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Lactic Acid suppliers with USDMF on PharmaCompass.
A L-Lactic Acid CEP of the European Pharmacopoeia monograph is often referred to as a L-Lactic Acid Certificate of Suitability (COS). The purpose of a L-Lactic Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Lactic Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Lactic Acid to their clients by showing that a L-Lactic Acid CEP has been issued for it. The manufacturer submits a L-Lactic Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Lactic Acid CEP holder for the record. Additionally, the data presented in the L-Lactic Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Lactic Acid DMF.
A L-Lactic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Lactic Acid 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 L-Lactic Acid suppliers with CEP (COS) on PharmaCompass.
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 L-Lactic Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for L-Lactic Acid API and other APIs are published in this directory by the FDA.
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 L-Lactic Acid 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.
The NDC directory also contains data on finished compounded human drug products that contain L-Lactic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a L-Lactic Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of L-Lactic Acid suppliers with NDC on PharmaCompass.
L-Lactic Acid 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 L-Lactic Acid 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 L-Lactic Acid GMP manufacturer or L-Lactic Acid GMP API supplier for your needs.
A L-Lactic Acid CoA (Certificate of Analysis) is a formal document that attests to L-Lactic Acid's compliance with L-Lactic Acid specifications and serves as a tool for batch-level quality control.
L-Lactic Acid CoA mostly includes findings from lab analyses of a specific batch. For each L-Lactic Acid 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.
L-Lactic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Lactic Acid EP), L-Lactic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Lactic Acid USP).