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1. (r-)-3-isobutyl Gaba
2. (s)-3-(aminomethyl)-5-methylhexanoic Acid
3. (s+)-3-isobutyl Gaba
4. 1008, Ci
5. 3 Isobutyl Gaba
6. 3-(aminomethyl)-5-methylhexanoic Acid
7. 3-isobutyl Gaba
8. Ci 1008
9. Ci-1008
10. Ci1008
11. Gaba, 3-isobutyl
12. Lyrica
1. 148553-50-8
2. Lyrica
3. (s)-3-(aminomethyl)-5-methylhexanoic Acid
4. 3-isobutyl Gaba
5. (3s)-3-(aminomethyl)-5-methylhexanoic Acid
6. Ci-1008
7. (s)-pregabalin
8. Hexanoic Acid, 3-(aminomethyl)-5-methyl-, (3s)-
9. Vronogabic
10. Ci 1008
11. Pregabalin Mylan
12. Pregabalin Sandoz
13. Pd 144723
14. Pd-144723
15. Pregabalin Zentiva
16. Pregabalin Sandoz Gmbh
17. (s)-3-isobutyl Gaba
18. Chembl1059
19. Chebi:64356
20. (3s)-3-(aminomethyl)-5-methyl-hexanoic Acid
21. 55jg375s6m
22. Ynp-1807
23. Nsc-759256
24. Hexanoic Acid, 3-(aminomethyl)-5-ethyl-, (3s)-
25. (r-)-3-isobutyl Gaba
26. Pregabalin [usan]
27. Hexanoic Acid, 3-(aminomethyl)-5-methyl-, (s)-
28. Pregabalina
29. Pregabaline
30. Nervalin
31. Pregablin
32. Unii-55jg375s6m
33. Hsdb 7530
34. Pregabalin [usan:inn:ban:jan]
35. Ncgc00095186-01
36. Pregabalin- Bio-x
37. Lyrica (tn)
38. Mfcd00917044
39. Lyrica Cr
40. Pregabalin [mi]
41. (s)-3-(aminomethyl)-5-methylhexanoicacid
42. Pregabalin [inn]
43. Pregabalin [jan]
44. Pregabalin [hsdb]
45. Pregabalin [vandf]
46. Pregabalin [mart.]
47. Schembl8227
48. Dsstox_cid_25950
49. Dsstox_rid_81246
50. Pregabalin [usp-rs]
51. Pregabalin [who-dd]
52. Dsstox_gsid_45950
53. Pregabalin (jan/usan/inn)
54. Pregabalin [ema Epar]
55. Pregabalin Mylan Pharma
56. (s)-(+)-4-amino-3-(2-methylpropyl)butanoic Acid
57. Gtpl5484
58. Zinc5152
59. Dea No. 2782
60. Pregabalin, >=97% (nmr)
61. Dtxsid1045950
62. Pregabalin [orange Book]
63. Pregabalin [ep Monograph]
64. Hms3715j16
65. Pregabalin [usp Monograph]
66. Pregabalin 1.0 Mg/ml In Methanol
67. Tox21_111475
68. Bdbm50164279
69. Akos001476611
70. Akos005145504
71. Lyrica;ci-1008;pd-144723
72. Ac-1158
73. Ccg-221247
74. Cs-1247
75. Db00230
76. Ks-5378
77. Nsc 759256
78. (s)-3-aminomethyl-5-methylhexanoic Acid
79. Ncgc00346738-01
80. 121ge001
81. Bp163672
82. Hy-17414
83. (s)-3-aminomethyl-5-methyl-hexanoic Acid
84. Am20080369
85. Cas-148553-50-8
86. P2840
87. En300-92104
88. (3s)-3-(aminomethyl)-5-methyl Hexanoic Acid
89. (s)-(+)-3-aminomethyl-5-methylhexanoic Acid
90. D02716
91. Ab01563007_01
92. 553p508
93. A808784
94. Q412174
95. Sr-01000942257
96. Sr-01000942257-2
97. Pregabalin, Europepharmacopoeia (ep) Reference Standard
98. Z2757554242
99. 1414928-41-8
| Molecular Weight | 159.23 g/mol |
|---|---|
| Molecular Formula | C8H17NO2 |
| XLogP3 | -1.6 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 5 |
| Exact Mass | 159.125928785 g/mol |
| Monoisotopic Mass | 159.125928785 g/mol |
| Topological Polar Surface Area | 63.3 Ų |
| Heavy Atom Count | 11 |
| Formal Charge | 0 |
| Complexity | 123 |
| 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 |
| 1 of 4 | |
|---|---|
| Drug Name | Lyrica |
| PubMed Health | Pregabalin (By mouth) |
| Drug Classes | Anticonvulsant, Neuropathic Pain Agent |
| Drug Label | Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:Pregabalin is a white to off-white, crystalline solid with... |
| Active Ingredient | Pregabalin |
| Dosage Form | Capsule; Solution |
| Route | oral; Oral |
| Strength | 20mg/ml; 200mg; 25mg; 150mg; 300mg; 75mg; 100mg; 50mg; 225mg |
| Market Status | Prescription |
| Company | Pf Prism; Cp Pharms |
| 2 of 4 | |
|---|---|
| Drug Name | Pregabalin |
| PubMed Health | Pregabalin (By mouth) |
| Drug Classes | Anticonvulsant, Neuropathic Pain Agent |
| Drug Label | Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:Pregabalin is a white to off-white, crystalline solid with... |
| Active Ingredient | Pregabalin |
| Dosage Form | Capsule; Solution |
| Route | oral; Oral |
| Strength | 20mg/ml; 200mg; 25mg; 150mg; 300mg; 75mg; 100mg; 50mg; 225mg |
| Market Status | Tentative Approval; Prescription |
| Company | Mylan Pharms; Apotex; Lupin; Sandoz; Watson Labs; Actavis Elizabeth; Teva Pharms; Wockhardt Usa |
| 3 of 4 | |
|---|---|
| Drug Name | Lyrica |
| PubMed Health | Pregabalin (By mouth) |
| Drug Classes | Anticonvulsant, Neuropathic Pain Agent |
| Drug Label | Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:Pregabalin is a white to off-white, crystalline solid with... |
| Active Ingredient | Pregabalin |
| Dosage Form | Capsule; Solution |
| Route | oral; Oral |
| Strength | 20mg/ml; 200mg; 25mg; 150mg; 300mg; 75mg; 100mg; 50mg; 225mg |
| Market Status | Prescription |
| Company | Pf Prism; Cp Pharms |
| 4 of 4 | |
|---|---|
| Drug Name | Pregabalin |
| PubMed Health | Pregabalin (By mouth) |
| Drug Classes | Anticonvulsant, Neuropathic Pain Agent |
| Drug Label | Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:Pregabalin is a white to off-white, crystalline solid with... |
| Active Ingredient | Pregabalin |
| Dosage Form | Capsule; Solution |
| Route | oral; Oral |
| Strength | 20mg/ml; 200mg; 25mg; 150mg; 300mg; 75mg; 100mg; 50mg; 225mg |
| Market Status | Tentative Approval; Prescription |
| Company | Mylan Pharms; Apotex; Lupin; Sandoz; Watson Labs; Actavis Elizabeth; Teva Pharms; Wockhardt Usa |
Pregabalin is indicated for management of post-herpetic neuralgia. /Included in US product label/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2412
Pregabalin is indicated for management of neuropathic pain associated with diabetic peripheral neuropathy. /Included in US product labe/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2412
Pregabalin is indicated as an adjunctive therapy for adult patients with partial onset seizures. /Included in US product label/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2412
The U.S. Food and Drug Administration ... has approved Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue and sleep problems.
FDA; FDA News (P07-107). Available from, as of July 31, 2007: https://www.fda.gov/bbs/topics/NEWS/2007/NEW01656.html
Known hypersensitivity to pregabalin or any ingredient in the formulation.
McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2247
Because of the possibility of increased seizure frequency, anticonvulsant drugs, including pregabalin, should be withdrawn gradually and dosage reduced slowly over at least 1 week. Abrupt discontinuance of pregabalin has been associated with insomnia, nausea, headache, and diarrhea.
McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2247
In controlled studies, blurred vision, which was reported in 6 or 2% of patients receiving pregabalin or placebo, respectively, resolved in the majority of cases with continued dosing; less than 1% of patients required discontinuance of the drug. In addition, decreased visual acuity was reported in 7 or 5% of patients receiving pregabalin or placebo, respectively, while visual field changes were detected in 13 or 12% of patients receiving the drug or placebo, respectively, and funduscopic changes were observed in 2% of patients receiving pregabalin or placebo. The clinical importance of these ophthalmologic findings has not been elucidated. If visual disturbance persists, further ocular assessment should be considered, while more frequent assessment is recommended in patients who already are monitored for ocular conditions.
McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2247
Weight gain, which was related to dosage and duration of exposure to pregabalin, has been reported in patients receiving pregabalin. Weight gain did not appear to be associated with baseline body mass index (BMI), gender, or age and was not limited to patients with edema.
McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2247
For more Drug Warnings (Complete) data for PREGABALIN (20 total), please visit the HSDB record page.
Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, fibromyalgia, neuropathic pain associated with spinal cord injury, and as adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older.
FDA Label
* Neuropathic pain:
- Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.
* Epilepsy :
- Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
* Generalised anxiety disorder:
- Lyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
* Epilepsy :
Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
* Generalised Anxiety Disorder:
Pregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
* Neuropathic pain:
Pregabalin Mylan is indicated for the treatment of peripheral and central neuropathic pain in adults.
* Epilepsy :
Pregabalin Mylan is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
* Generalised Anxiety Disorder:
Pregabalin Mylan is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Neuropathic pain
- Pregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults.
Epilepsy
- Pregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Generalised Anxiety Disorder
- Pregabalin Pfizer is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
* Neuropathic pain:
- Pregabalin Zentiva k. s. is indicated for the treatment of peripheral and central neuropathic pain in adults.
* Epilepsy :
- Pregabalin Zentiva k. s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
* Generalised anxiety disorder:
- Pregabalin Zentiva k. s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Epilepsy
- Pregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Generalised Anxiety Disorder
- Pregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
* Neuropathic pain:
- Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults.
* Epilepsy :
- Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
* Generalised anxiety disorder:
- Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
* Epilepsy :
Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
* Generalised Anxiety Disorder:
Pregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
* Neuropathic pain:
Pregabalin Sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults.
* Epilepsy :
Pregabalin Sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
* Generalised Anxiety Disorder:
Pregabalin Sandoz is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Alleviation of acute anxiety and fear associated with transportation and veterinary visits.
Although the structure of pregabalin is similar to gamma-aminobutyric acid (GABA), it does not bind to GABA receptors. Instead, it binds the alpha2-delta subunit of presynaptic voltage-gated calcium channels in the central nervous system. Pregabalin does not modulate dopamine receptors, serotonin receptors, opiate receptors, sodium channels or cyclooxygenase activity.
Anti-Anxiety Agents
Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)
Analgesics
Compounds capable of relieving pain without the loss of CONSCIOUSNESS. (See all compounds classified as Analgesics.)
Calcium Channel Blockers
A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)
Anticonvulsants
Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)
N03AX16
N03AX16
N03AX16
N03AX16
N03AX16
N03AX16
N03AX16
N03AX16
N03AX16
QN03AX16
N03AX16
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
N - Nervous system
N03 - Antiepileptics
N03A - Antiepileptics
N03AX - Other antiepileptics
N03AX16 - Pregabalin
Absorption
After oral dosing administered in the fasted state, pregabalin absorption is rapid, and extensive. Pregabalin oral bioavailability is reported to be 90% regardless of the dose. Cmax is attained within 1.5 hours after single or multiple doses, and steady state is attained within 24-48 hours with repeated administration. Both Cmax and AUC appear to be dose proportional. Food decreases the rate of pregabalin absorption and as a result, lowers the Cmax by an estimated 25-30% and increases the Tmax to approximately 3 hours. However, the effect of food does not appear to impact the total absorption of pregabalin in a way that is clinically relevant. As a result, pregabalin can be administered with or without food.
Route of Elimination
Pregabalin is almost exclusively eliminated in the urine. Further, based on preclinical studies, pregabalin does not appear to undergo racemization to the R enantiomer in the body.
Volume of Distribution
After oral administration of pregabalin, the reported apparent volume of distribution is roughly 0.5 L/kg. Although pregabalin is not very lipophilic, it is able to cross the blood brain barrier(BBB). System L transporters facilitate the transport of large amino acids across the BBB and it has been confirmed that pregabalin is a substrate. This information suggests that system L transporters are responsible for pregabalin uptake into the BBB. In rat models, pregabalin has been shown to cross the placenta.
Clearance
In young healthy subjects the mean renal clearance is estimated to be 67.0 to 80.9 mL mL/min. Given pregabalin's lack of plasma protein binding, this clearance rate suggests that renal tubular reabsorption is involved.
Pregabalin is well absorbed after oral administration ...
Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2539
Following oral administration of pregabalin capsules under fasting conditions, peak plasma concentrations occur within 1.5 hours. Pregabalin oral bioavailability is >/=90% and is independent of dose. Following single- (25 to 300 mg) and multiple-dose (75 to 900 mg/day) administration, maximum plasma concentrations (C max ) and area under the plasma concentration-time curve (AUC) values increase linearly. Following repeated administration, steady state is achieved within 24 to 48 hours. Multiple-dose pharmacokinetics can be predicted from single-dose data.
Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2539
The rate of pregabalin absorption is decreased when given with food, resulting in a decrease in Cmax of approximately 25% to 30% and an increase in Tmax to approximately 3 hours. However, administration of pregabalin with food has no clinically relevant effect on the total absorption of pregabalin. Therefore, pregabalin can be taken with or without food.
Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2539
Pregabalin does not bind to plasma proteins. The apparent volume of distribution of pregabalin following oral administration is approximately 0.5 L/kg. Pregabalin is a substrate for system L transporter which is responsible for the transport of large amino acids across the blood brain barrier. Although there are no data in humans, pregabalin has been shown to cross the blood brain barrier in mice, rats, and monkeys. In addition, pregabalin has been shown to cross the placenta in rats and is present in the milk of lactating rats.
Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2539
For more Absorption, Distribution and Excretion (Complete) data for PREGABALIN (8 total), please visit the HSDB record page.
Less than 2% of pregabalin is metabolized and it is excreted virtually unchanged in the urine.
Pregabalin undergoes negligible metabolism in humans. Following a dose of radiolabeled pregabalin, approximately 90% of the administered dose was recovered in the urine as unchanged pregabalin. The N-methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose. In preclinical studies, pregabalin (S-enantiomer) did not undergo racemization to the R-enantiomer in mice, rats, rabbits, or monkeys.
Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2540
The elimination half life of pregabalin is 6.3 hours.
Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug with a mean elimination half-life of 6.3 hours in subjects with normal renal function.
Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2540
Although the mechanism of action has not been fully elucidated, studies involving structurally related drugs suggest that presynaptic binding of pregabalin to voltage-gated calcium channels is key to the antiseizure and antinociceptive effects observed in animal models. By binding presynaptically to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system, pregabalin modulates the release of several excitatory neurotransmitters including glutamate, substance-P, norepinephrine, and calcitonin gene related peptide. In addition, pregabalin prevents the alpha2-delta subunit from being trafficked from the dorsal root ganglia to the spinal dorsal horn, which may also contribute to the mechanism of action. Although pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), it does not bind directly to GABA or benzodiazepine receptors.
Pregabalin is an anticonvulsant that is structurally related to the inhibitory CNS neurotransmitter gamma-aminobutyric acid (GABA). Pregabalin also has demonstrated analgesic activity. Although pregabalin was developed as a structural analog of GABA, the drug does not bind directly to GABA-A, GABA-B, or benzodiazepine receptors; does not augment GABA-A responses in cultured neurons; and does not alter brain concentrations of GABA in rats or affect GABA uptake or degradation. However, in cultured neurons, prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport.
McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2248
Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in CNS tissues. ... In vitro, pregabalin reduces the calcium-dependent release of several neurotransmitters, including glutamate, norepinephrine, and substance P, possibly by modulation of calcium channel function.
McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 2248
Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake.
Physicians Desk Reference 61st ed, Thomson PDR, Montvale, NJ 2007., p. 2539
Pregabalin is a potent ligand for the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system that exhibits potent anticonvulsant, analgesic, and anxiolytic activity in a range of animal models. ... Potent binding to the alpha-2-delta site reduces depolarization-induced calcium influx with a consequential modulation in excitatory neurotransmitter release. Pregabalin has no demonstrated effects on GABAergic mechanisms. ...
PMID:15315511 Ben-Menachem E; Epilepsia 45 Suppl 6: 13-8 (2004)
For more Mechanism of Action (Complete) data for PREGABALIN (6 total), please visit the HSDB record page.
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Drugs in Development
Details:
USFDA approved generic version of Pregabalin treatment of fibromyalgia. It binds to the alpha2-delta subunit which is involved in anti-nociceptive and antiseizure effects.
Lead Product(s): Pregabalin
Therapeutic Area: Musculoskeletal Brand Name: Lyrica-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 25, 2024
Lead Product(s) : Pregabalin
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Strides Receives USFDA Approval for Pregabalin Capsules
Details : USFDA approved generic version of Pregabalin treatment of fibromyalgia. It binds to the alpha2-delta subunit which is involved in anti-nociceptive and antiseizure effects.
Product Name : Lyrica-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 25, 2024
Details:
Lyrica-Generic (pregabalin) is a calcium channel alpha-2/delta-1 subunit binder, indicated for Neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia & fibromyalgia.
Lead Product(s): Pregabalin
Therapeutic Area: Neurology Brand Name: Lyrica-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 21, 2024
Lead Product(s) : Pregabalin
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Indoco Remedies Receives Final ANDA Approval from USFDA for Pregabalin Capsules
Details : Lyrica-Generic (pregabalin) is a calcium channel alpha-2/delta-1 subunit binder, indicated for Neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia & fibromyalgia.
Product Name : Lyrica-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 21, 2024
Details:
Pregabalin Prolonged Release Tablets is a unique formulation helps in increasing patient's adherence, it is the backbone medication indicated in the treatment of Neuropathic pain.
Lead Product(s): Pregabalin
Therapeutic Area: Neurology Brand Name: Lyrica CR-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 22, 2023
Lead Product(s) : Pregabalin
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Adalvo Announces Successful DCP Approval of Pregabalin Prolonged Release Tablets
Details : Pregabalin Prolonged Release Tablets is a unique formulation helps in increasing patient's adherence, it is the backbone medication indicated in the treatment of Neuropathic pain.
Product Name : Lyrica CR-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 22, 2023
Details:
Lyrica-Generic (pregabalin) is a calcium channel alpha-2/delta-1 subunit binder, indicated for Neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia & fibromyalgia.
Lead Product(s): Pregabalin
Therapeutic Area: Neurology Brand Name: Lyrica-Generic
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) : Pregabalin
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Aurobindo Receives FDA Approval for Pregabalin Capsules
Details : Lyrica-Generic (pregabalin) is a calcium channel alpha-2/delta-1 subunit binder, indicated for Neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia & fibromyalgia.
Product Name : Lyrica-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 30, 2023
Details:
AFD-NP is a combination of Nortriptyline and Pregabalin which has approved for the treatment of moderate to severe neuropathic pain.
Lead Product(s): Pregabalin,Nortriptyline
Therapeutic Area: Neurology Brand Name: AFD-NP
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 27, 2023
Lead Product(s) : Pregabalin,Nortriptyline
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Launch of AFD-NP Product for Neuropathic Pain Management
Details : AFD-NP is a combination of Nortriptyline and Pregabalin which has approved for the treatment of moderate to severe neuropathic pain.
Product Name : AFD-NP
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 27, 2023
Details:
Lyrica-Generic (pregabalin) is a calcium channel alpha-2/delta-1 subunit binder, indicated for Neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia & fibromyalgia.
Lead Product(s): Pregabalin
Therapeutic Area: Neurology Brand Name: Lyrica-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 22, 2022
Lead Product(s) : Pregabalin
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Alembic Announces its First Product Approval from its Formulation Division IV
Details : Lyrica-Generic (pregabalin) is a calcium channel alpha-2/delta-1 subunit binder, indicated for Neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia & fibromyalgia.
Product Name : Lyrica-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 22, 2022
Details:
Lyrica-Generic (pregabalin) is a calcium channel alpha-2/delta-1 subunit binder, indicated for Neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia & fibromyalgia.
Lead Product(s): Pregabalin
Therapeutic Area: Neurology Brand Name: Lyrica-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 12, 2022
Lead Product(s) : Pregabalin
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Zydus Receives Two Final Approvals from The USFDA for Silodosin and Pregabalin
Details : Lyrica-Generic (pregabalin) is a calcium channel alpha-2/delta-1 subunit binder, indicated for Neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia & fibromyalgia.
Product Name : Lyrica-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 12, 2022
Details:
Pregabalin, to market a generic equivalent of Lyrica® Capsules, is used to treat pain caused by nerve damage due to diabetes or to shingles (herpes zoster) infection.
Lead Product(s): Pregabalin
Therapeutic Area: Neurology Brand Name: Pregabalin-Generic
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) : Pregabalin
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lupin Receives USFDA Approval to Market Generic Pregabalin Capsules
Details : Pregabalin, to market a generic equivalent of Lyrica® Capsules, is used to treat pain caused by nerve damage due to diabetes or to shingles (herpes zoster) infection.
Product Name : Pregabalin-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 05, 2022
Details:
With the acquisition, Endo controls all remaining development, approval, launch and commercialization activities for the product candidates, NVK009 (Gabapentin). Endo's Par Sterile Products business will commercialize the products in the United States.
Lead Product(s): Gabapentin,Paracetamol,Pregabalin
Therapeutic Area: Neurology Brand Name: NVK009
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Endo International
Deal Size: $35.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition February 05, 2022
Lead Product(s) : Gabapentin,Paracetamol,Pregabalin
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Endo International
Deal Size : $35.0 million
Deal Type : Acquisition
Endo Acquires Six Development-Stage, Ready-to-Use Injectable Product Candidates From Nevakar
Details : With the acquisition, Endo controls all remaining development, approval, launch and commercialization activities for the product candidates, NVK009 (Gabapentin). Endo's Par Sterile Products business will commercialize the products in the United States.
Product Name : NVK009
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
February 05, 2022
Details:
XG005 is a drug conjugate of naproxen and pregabalin which is being investigated for the management of acute pain.
Lead Product(s): Pregabalin,Naproxen
Therapeutic Area: Neurology Brand Name: XG005
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 22, 2020
Lead Product(s) : Pregabalin,Naproxen
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
NDA Application of XG005 will Follows a Regulatory Pathway Bosed on FDA’s Feedback
Details : XG005 is a drug conjugate of naproxen and pregabalin which is being investigated for the management of acute pain.
Product Name : XG005
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 22, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info : Available with Preclinical Package
Registration Country : Hungary
Brand Name :
Dosage Form : Topical Form
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Available with Preclinical Package
Registration Country : Hungary
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pregabalin Zentiva
Dosage Form : Capsules
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pregabalin Zentiva
Dosage Form : Capsules
Dosage Strength : 150mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pregabalin Zentiva
Dosage Form : Kaps
Dosage Strength : 200mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pregabalin Zentiva
Dosage Form : Capsules
Dosage Strength : 25mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pregabalin Zentiva
Dosage Form : Capsules
Dosage Strength : 25mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pregabalin Zentiva
Dosage Form : Kaps
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pregabalin Zentiva
Dosage Form : Kaps
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pregabalin Zentiva
Dosage Form : Capsules
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Pregabalin Zentiva
Dosage Form : Capsules
Dosage Strength : 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 165M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 165MG
USFDA APPLICATION NUMBER - 209501
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 330M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 330MG
USFDA APPLICATION NUMBER - 209501
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 82.5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 82.5MG
USFDA APPLICATION NUMBER - 209501
DOSAGE - CAPSULE;ORAL - 100MG
USFDA APPLICATION NUMBER - 21446
DOSAGE - CAPSULE;ORAL - 150MG
USFDA APPLICATION NUMBER - 21446
DOSAGE - CAPSULE;ORAL - 200MG
USFDA APPLICATION NUMBER - 21446
DOSAGE - CAPSULE;ORAL - 225MG
USFDA APPLICATION NUMBER - 21446
DOSAGE - CAPSULE;ORAL - 25MG
USFDA APPLICATION NUMBER - 21446
DOSAGE - CAPSULE;ORAL - 300MG
USFDA APPLICATION NUMBER - 21446
DOSAGE - CAPSULE;ORAL - 50MG
USFDA APPLICATION NUMBER - 21446
DOSAGE - CAPSULE;ORAL - 75MG
USFDA APPLICATION NUMBER - 21446
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Dosage Form : Capsule
Grade : Oral
Application : Fillers, Diluents & Binders
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 857 g/l, Bulk density- 589 g/l; Particle size- D10- 5 ?m, D50- 40 ?m, D90-...
Ingredient(s) : Lactose Monohydrate
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 716 g/l, Bulk density- 599 g/l; Particle size- D10-50 ?m, D50- 120 ?m, D90-...
Ingredient(s) : Lactose Monohydrate
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
SPI Pharma has been solving formulation challenges using superior functional materials.
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
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Thickeners and Stabilizers
Brand Name : GELATIN BOVINE 140B 6M
Application : Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Gelatin bovine 140B 6M is used as a stabilizer in parenteral drug products and as a binder and filler in capsules, tablets, granules, and pellets.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Brand Name : Lactose Monohydrate
Application : Fillers, Diluents & Binders
Excipient Details : Lactose monohydrate is widely used as a filler and diluent in solid dosage forms such as tablets.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Brand Name : Lactose Monohydrate
Application : Parenteral
Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Brand Name : Pregelatinized Corn Starch
Application : Fillers, Diluents & Binders
Excipient Details : Corn starch is used as a filler and binder in pharmaceutical oral solid dosage forms, including tablets.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Thickeners and Stabilizers
Application : Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Gelita RXL R² 115B BB TB Ph is used as a stabilizer in parenteral formulations and as a filler and binder in tablets, capsules, granules, and pellets.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
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
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Thickeners and Stabilizers
Brand Name : PIG SKIN GELATIN 100B 20M
Application : Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Pig skin gelatin 100B 20M is used as a filler and binder in capsules, tablets, pellets, and granules and as a stabilizer in parenteral formulations.
Dosage Form : Capsule, Injectable / Parenteral, Tablet
Grade : Oral, Parenteral
Category : Fillers, Diluents & Binders, Parenteral
Brand Name : Lactose Monohydrate
Application : Fillers, Diluents & Binders, Parenteral
Excipient Details : Lactose Monohydrate is widely used as a filler and diluent in tablets and capsules and in the production of lyophilized and parenteral products.
Coating Systems & Additives
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : Titanium dioxide PRETIOX AV01PhG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01PhG is used as a coating and coloring agent in oral solids such as tablets, capsules, granules, and pellets.
Dosage Form : Tablet
Grade : Not Available
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : Immediate Release
Pharmacopoeia Ref : Customized per requirements
Technical Specs : Not Available
Ingredient(s) : Starch
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D WHITE 010.01 MS
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Grade : Oral
Category : Coating Systems & Additives, Film Formers & Plasticizers
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : Ready mix Non-Functional film coating system.
Pharmacopoeia Ref : USP, EP, JP; Having US-DMF
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Application : Coating Systems & Additives, Taste Masking
Excipient Details : Ready mix sugar coating system.
Pharmacopoeia Ref : USP, EP, JP & having US DMF
Technical Specs : Sprayable sugar coating system for solid oral dosage form
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet, Topical Film
Grade : Not Available
Category : Coating Systems & Additives, Controlled & Modified Release, Taste Masking
Brand Name : Kollicoat SR 30 D
Application : Coating Systems & Additives, Controlled & Modified Release, Taste Masking
Excipient Details : pH-independent sustained release coating for small particles, pellets, granules and tablets. Sprayable polymeric film former. Flexible. Wash resistant.
Pharmacopoeia Ref : Ph. Eur.: Poly(vinyl acetate) ...
Technical Specs : Not Available
Ingredient(s) : Polyvinyl Acetate
Application : Coating Systems & Additives
Excipient Details : Coating, Core-Sealing
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Coating Systems & Additives, Taste Masking
Brand Name : Kollicoat Smartseal 30 D
Application : Coating Systems & Additives, Taste Masking
Excipient Details : Taste masking at very low coating levels, suitable for pellets & particles for ODTs.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Diethylaminoethyl Methacrylate
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D WHITE 010.01
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Direct Compression
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Taste Masking
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Taste Masking
Excipient Details : Advantose® FS95 is spray-dried fructose coprocessed with starch, is a highly compressible pharmaceutical excipient with chewable vitamin applications.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Direct Compression, Taste Masking
Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170 µm, Tapped Density: 0.80
Ingredient(s) : Magnesium Hydroxide Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
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 : Not Available
Category : Direct Compression, Granulation, Lubricants & Glidants
Brand Name : Kolliphor SLS Fine
Application : Direct Compression, Granulation, Lubricants & Glidants
Excipient Details : Wetting agent, reducing disintegration time, direct compression, Hydrophilic lubricant, effervescent tablets.
Pharmacopoeia Ref : Ph. Eur.: Sodium Laurilsulfate...
Technical Specs : Not Available
Ingredient(s) : Sodium Lauryl Sulfate
Application : Direct Compression, Granulation
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Lubricants & Glidants
Application : Direct Compression, Fillers, Diluents & Binders, Lubricants & Glidants
Excipient Details : HiCel SMCC has unique combination which result in optimum compaction & superior flow properties.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Brand Name : Microlex® LCM 80.m
Application : Direct Compression, Granulation
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Milled; Also Available as Microlex® LCM 180.m, Microlex® LCM 20...
Ingredient(s) : Lactose Monohydrate
Brand Name : Microlex® LCM 120.s
Application : Direct Compression, Granulation
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Sieved; Also Available as Microlex® LCM 180.s, Microlex® LCM 22...
Ingredient(s) : Lactose Monohydrate
Dosage Form : Tablet
Grade : Oral and Parenteral
Category : Direct Compression, Fillers, Diluents & Binders
Application : Direct Compression, Fillers, Diluents & Binders
Excipient Details : Lactose is widely used as a filler and diluent in tablets and capsules, and to a more limited extent in lyophilized products and infant formulas.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Application : Direct Compression
Excipient Details : Capsule Filling, Direct Compression, Binding, Disintegration
Pharmacopoeia Ref : Not Available
Technical Specs : EXCiPACT
Ingredient(s) : Native & Pregelatinized Corn Starch
Taste Masking
Empty Capsules
Granulation
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Brand Name : Sodium Dodecyl Sulfate
Application : Granulation
Excipient Details : Sodium dodecyl sulfate is used in wet granulation tableting applications for the production of antacid tablets and digestive aids.
Dosage Form : Tablet
Grade : Oral
Category : Granulation, Lubricants & Glidants, Surfactant & Foaming Agents
Brand Name : Sodium Dodecyl Sulfate
Application : Granulation, Lubricants & Glidants, Surfactant & Foaming Agents
Excipient Details : Sodium Dodecyl Sulfate is used as an ionic surfactant, lubricant, and granulating agent in the solid dosage forms such as tablets.
Application : Fillers, Diluents & Binders, Granulation
Excipient Details : Fully Pregel Starch Corn is used as a binder in wet granulation in the manufacturing of tablets.
Pharmacopoeia Ref : USP/NF, Ph. Eur., Ch. P.
Technical Specs : NA
Ingredient(s) : Corn Starch, Pregelatinized
Application : Fillers, Diluents & Binders, Granulation
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 857 g/l, Bulk density- 589 g/l; Particle...
Ingredient(s) : Lactose Monohydrate
Application : Granulation
Excipient Details : Wetting agent, reduces disintegration time, Ionic solubilizer, high HLB anionic emulsifier for semi-solids and foams.
Pharmacopoeia Ref : Ph. Eur.: Sodium Laurilsulfate...
Technical Specs : Not Available
Ingredient(s) : Sodium Lauryl Sulfate
Grade : Not Available
Category : Direct Compression, Granulation, Lubricants & Glidants
Brand Name : Kolliphor SLS Fine
Application : Direct Compression, Granulation, Lubricants & Glidants
Excipient Details : Wetting agent, reducing disintegration time, direct compression, Hydrophilic lubricant, effervescent tablets.
Pharmacopoeia Ref : Ph. Eur.: Sodium Laurilsulfate...
Technical Specs : Not Available
Ingredient(s) : Sodium Lauryl Sulfate
Application : Direct Compression, Granulation
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Microlex® LCM 80.m
Application : Direct Compression, Granulation
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Milled; Also Available as Microlex® LCM 180.m, Microlex® LCM 20...
Ingredient(s) : Lactose Monohydrate
Brand Name : Microlex® LCM 120.s
Application : Direct Compression, Granulation
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Sieved; Also Available as Microlex® LCM 180.s, Microlex® LCM 22...
Ingredient(s) : Lactose Monohydrate
Thickeners and Stabilizers
Lubricants & Glidants
Co-Processed Excipients
Film Formers & Plasticizers
Topical
Disintegrants & Superdisintegrants
Application : Fillers, Diluents & Binders
Excipient Details : Corn Starch is used as a filler and binder in pharmaceutical oral solid dosage forms including tablets and capsules.
Grade : Not Available
Category : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
Application : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
Excipient Details : Tablet and capsule diluent, tablet and capsule disintegrant and tablet binder.
Dosage Form : Capsule, Granule / Pellet, Orodispersible Tablet, Softgel Capsule, Tablet
Grade : Not Available
Category : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
Application : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
Excipient Details : Used as disintegrants, fillers and binders (once cooked) in nutraceutical and pharmaceutical dosage forms.
Dosage Form : Capsule, Granule / Pellet, Orodispersible Tablet, Softgel Capsule, Tablet
Grade : Not Available
Category : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
Brand Name : POWDERED NF CORN STARCH
Application : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
Excipient Details : Used as disintegrants, fillers and binders (once cooked) in nutraceutical and pharmaceutical dosage forms.
Coloring Agents
Controlled & Modified Release
Chewable & Orodispersible Aids
Emulsifying Agents
Parenteral
Solubilizers
API Stability Enhancers
Surfactant & Foaming Agents
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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.
A TOS-BB-0910 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TOS-BB-0910, including repackagers and relabelers. The FDA regulates TOS-BB-0910 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TOS-BB-0910 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 TOS-BB-0910 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A TOS-BB-0910 supplier is an individual or a company that provides TOS-BB-0910 active pharmaceutical ingredient (API) or TOS-BB-0910 finished formulations upon request. The TOS-BB-0910 suppliers may include TOS-BB-0910 API manufacturers, exporters, distributors and traders.
click here to find a list of TOS-BB-0910 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TOS-BB-0910 DMF (Drug Master File) is a document detailing the whole manufacturing process of TOS-BB-0910 active pharmaceutical ingredient (API) in detail. Different forms of TOS-BB-0910 DMFs exist exist since differing nations have different regulations, such as TOS-BB-0910 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TOS-BB-0910 DMF submitted to regulatory agencies in the US is known as a USDMF. TOS-BB-0910 USDMF includes data on TOS-BB-0910's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TOS-BB-0910 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TOS-BB-0910 suppliers with USDMF on PharmaCompass.
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 TOS-BB-0910 Drug Master File in Japan (TOS-BB-0910 JDMF) empowers TOS-BB-0910 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 TOS-BB-0910 JDMF during the approval evaluation for pharmaceutical products. At the time of TOS-BB-0910 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 TOS-BB-0910 suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a TOS-BB-0910 Drug Master File in Korea (TOS-BB-0910 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TOS-BB-0910. The MFDS reviews the TOS-BB-0910 KDMF as part of the drug registration process and uses the information provided in the TOS-BB-0910 KDMF to evaluate the safety and efficacy of the drug.
After submitting a TOS-BB-0910 KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their TOS-BB-0910 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of TOS-BB-0910 suppliers with KDMF on PharmaCompass.
A TOS-BB-0910 CEP of the European Pharmacopoeia monograph is often referred to as a TOS-BB-0910 Certificate of Suitability (COS). The purpose of a TOS-BB-0910 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of TOS-BB-0910 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of TOS-BB-0910 to their clients by showing that a TOS-BB-0910 CEP has been issued for it. The manufacturer submits a TOS-BB-0910 CEP (COS) as part of the market authorization procedure, and it takes on the role of a TOS-BB-0910 CEP holder for the record. Additionally, the data presented in the TOS-BB-0910 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the TOS-BB-0910 DMF.
A TOS-BB-0910 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. TOS-BB-0910 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 TOS-BB-0910 suppliers with CEP (COS) on PharmaCompass.
A TOS-BB-0910 written confirmation (TOS-BB-0910 WC) is an official document issued by a regulatory agency to a TOS-BB-0910 manufacturer, verifying that the manufacturing facility of a TOS-BB-0910 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TOS-BB-0910 APIs or TOS-BB-0910 finished pharmaceutical products to another nation, regulatory agencies frequently require a TOS-BB-0910 WC (written confirmation) as part of the regulatory process.
click here to find a list of TOS-BB-0910 suppliers with Written Confirmation (WC) 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 TOS-BB-0910 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TOS-BB-0910 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 TOS-BB-0910 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 TOS-BB-0910 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TOS-BB-0910 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TOS-BB-0910 suppliers with NDC on PharmaCompass.
TOS-BB-0910 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 TOS-BB-0910 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 TOS-BB-0910 GMP manufacturer or TOS-BB-0910 GMP API supplier for your needs.
A TOS-BB-0910 CoA (Certificate of Analysis) is a formal document that attests to TOS-BB-0910's compliance with TOS-BB-0910 specifications and serves as a tool for batch-level quality control.
TOS-BB-0910 CoA mostly includes findings from lab analyses of a specific batch. For each TOS-BB-0910 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.
TOS-BB-0910 may be tested according to a variety of international standards, such as European Pharmacopoeia (TOS-BB-0910 EP), TOS-BB-0910 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TOS-BB-0910 USP).
