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Cetrorelix Acetate

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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21 API Suppliers, 10 USDMF, 2 JDMF, 1 EU WC, 11 NDC API, 17 Listed Suppliers, $ API Reference Price

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2 South Africa
9 Listed Dossiers

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POWDER;SUBCUTANEOUS - EQ 0.25MG BASE/VIAL, POWDER;SUBCUTANEOUS - EQ 3MG BASE/VIAL

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Chemistry

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Also known as: 120287-85-6, Cetrotide, Cetrorelixum, Sb 75, Cetrorelixum [inn-latin], Cetrorelix (inn)

Molecular Formula

C₇₀H₉₂ClN₁₇O₁₄

Molecular Weight

1431.0 g/mol

InChI Key

SBNPWPIBESPSIF-MHWMIDJBSA-N

FDA UNII

OON1HFZ4BA

Cetrorelix is cetrorelix is a synthetic decapeptide which is structurally related to gonadotrophin-releasing hormone (luteinising-hormone releasing hormone). It acts as an LHRH antagonist. (from ASTA Medica)

Cetrorelix is a Gonadotropin Releasing Hormone Receptor Antagonist. The mechanism of action of cetrorelix is as a Gonadotropin Releasing Hormone Receptor Antagonist. The physiologic effect of cetrorelix is by means of Decreased GnRH Secretion.

1 2D Structure

Cetrorelix Acetate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2S)-1-[(2S)-2-[[(2S)-2-[[(2R)-2-[[(2S)-2-[[(2S)-2-[[(2R)-2-[[(2R)-2-[[(2R)-2-acetamido-3-naphthalen-2-ylpropanoyl]amino]-3-(4-chlorophenyl)propanoyl]amino]-3-pyridin-3-ylpropanoyl]amino]-3-hydroxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-5-(carbamoylamino)pentanoyl]amino]-4-methylpentanoyl]amino]-5-(diaminomethylideneamino)pentanoyl]-N-[(2R)-1-amino-1-oxopropan-2-yl]pyrrolidine-2-carboxamide

2.1.2 InChI

InChI=1S/C70H92ClN17O14/c1-39(2)31-52(61(94)82-51(15-9-28-77-69(73)74)68(101)88-30-10-16-58(88)67(100)79-40(3)59(72)92)83-60(93)50(14-8-29-78-70(75)102)81-63(96)54(34-43-20-25-49(91)26-21-43)86-66(99)57(38-89)87-65(98)56(36-45-11-7-27-76-37-45)85-64(97)55(33-42-18-23-48(71)24-19-42)84-62(95)53(80-41(4)90)35-44-17-22-46-12-5-6-13-47(46)32-44/h5-7,11-13,17-27,32,37,39-40,50-58,89,91H,8-10,14-16,28-31,33-36,38H2,1-4H3,(H2,72,92)(H,79,100)(H,80,90)(H,81,96)(H,82,94)(H,83,93)(H,84,95)(H,85,97)(H,86,99)(H,87,98)(H4,73,74,77)(H3,75,78,102)/t40-,50-,51+,52+,53-,54+,55-,56-,57+,58+/m1/s1

2.1.3 InChI Key

SBNPWPIBESPSIF-MHWMIDJBSA-N

2.1.4 Canonical SMILES

CC(C)CC(C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NC(C)C(=O)N)NC(=O)C(CCCNC(=O)N)NC(=O)C(CC2=CC=C(C=C2)O)NC(=O)C(CO)NC(=O)C(CC3=CN=CC=C3)NC(=O)C(CC4=CC=C(C=C4)Cl)NC(=O)C(CC5=CC6=CC=CC=C6C=C5)NC(=O)C

2.1.5 Isomeric SMILES

C[C@H](C(=O)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCN=C(N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CCCNC(=O)N)NC(=O)[C@H](CC2=CC=C(C=C2)O)NC(=O)[C@H](CO)NC(=O)[C@@H](CC3=CN=CC=C3)NC(=O)[C@@H](CC4=CC=C(C=C4)Cl)NC(=O)[C@@H](CC5=CC6=CC=CC=C6C=C5)NC(=O)C

2.2 Other Identifiers

2.2.1 UNII

OON1HFZ4BA

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Cetrorelix Acetate

2. Cetrorelix Pamoate

3. Cetrotide

4. Lhrh, N-ac-1-nal(2)-2-phe(pcl)-3-pal(3)-6-cit-10-ala-

5. Lhrh, N-acetyl-1-(3-(2-naphthyl)alanyl)-2-(4-chlorophenylalanyl)-3-(3-(3-pyridyl)alanyl)-6-citrulline-10-alanine-

6. N-acetyl-1-(3-(2-naphthyl)alanine)-2-(4-chlorophenylalanine)-3-(3-(3-pyridyl)alanine)-6-citrulline-10-alanine-lhrh

7. Sb 75

8. Sb-75

2.3.2 Depositor-Supplied Synonyms

1. 120287-85-6

2. Cetrotide

3. Cetrorelixum

4. Sb 75

5. Cetrorelixum [inn-latin]

6. Cetrorelix (inn)

7. Cetrorelix [inn]

8. Sb-75

9. Oon1hfz4ba

10. Cetrotide (tn)

11. Chebi:59224

12. 130143-01-0

13. D-alaninamide,n-acetyl-3-(2-naphthalenyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridinyl)-d-alanyl-l-seryl-l-tyrosyl-n5-(aminocarbonyl)-d-ornithyl-l-leucyl-l-arginyl-l-prolyl-

14. Ac-(d-ala[3-(2-naphthyl)])-[d-phe(4-cl)]-(d-ala[3-(3-pyridyl)])-ser-tyr-(d-cit)-leu-arg-pro-d-ala-oh

15. N-acetyl-3-(2-naphthyl)-d-alanyl-p-chloro-d-phenylalanyl-3-(3-pyridyl)-d-alanyl-l-seryl-l-tyrosyl-n(sup 5)-carbamoyl-d-ornithyl-l-leucyl-l-arginyl-l-prolyl-d-alaninamide

16. Sb-075

17. Cetrorelix [inn:ban]

18. Unii-oon1hfz4ba

19. Hsdb 7696

20. Hs-2008

21. Cetrorelix [mi]

22. Cetrorelix [hsdb]

23. Cetrorelix [vandf]

24. Cetrorelix [who-dd]

25. Schembl61331

26. Cetrorelix [ema Epar]

27. Gtpl1190

28. Cetrorelix [orange Book]

29. Chembl1200490

30. Dtxsid7040996

31. Schembl19712202

32. Hy-p0009

33. Vea28785

34. Bdbm50369965

35. Ac-d-nal(2)-d-phe(pcl)-d-pal(3)-ser-tyr-d-cit-leu-arg-pro-d-ala-nh2

36. Akos015994648

37. Db00050

38. Ncgc00481544-01

39. Ncgc00485296-01

40. Ac-28734

41. N-acetyl-3-(2-naphthyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridyl)-d-alanyl-l-seryl-l-tyrosyl-n5-carbomoyl-d-ornithyl-l-leucyl-l-prolyl-d-alaninamide

42. N-acetyl-3-(naphthalen-2-yl)-d-alanyl-4-chloro-d-phenylalanyl-3-(pyridin-3-yl)-d-alanyl-l-seryl-l-tyrosyl-n(5)-carbamoyl-d-ornithyl-l-leucyl-l-arginyl-l-prolyl-d-alaninamide

43. Cs-0012400

44. D07665

45. 287c856

46. Q5065704

47. Y-100040

48. N-acetyl-3-(2-naphthalenyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridinyl)-d-alanyl-l-seryl-l-tyrosyl-n5-(aminocarbonyl)-d-ornithyl-l-leucyl-l-arginyl-l-prolyl-d-alaninamide

2.4 Create Date

2008-12-10

3 Chemical and Physical Properties

Molecular Formula	C₇₀H₉₂ClN₁₇O₁₄
Molecular Weight	1431.0 g/mol
XLogP3	1.9
Hydrogen Bond Donor Count	16
Hydrogen Bond Acceptor Count	16
Rotatable Bond Count	38
Exact Mass	1429.6698184 g/mol
Monoisotopic Mass	1429.6698184 g/mol
Topological Polar Surface Area	498 Å²
Heavy Atom Count	102
Formal Charge	0
Complexity	2840
Isotope Atom Count	0
Defined Atom Stereocenter Count	10
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Cetrotide
PubMed Health	Cetrorelix (Injection)
Drug Classes	Endocrine-Metabolic Agent
Active Ingredient	Cetrorelix
Dosage Form	Injectable
Route	Injection
Strength	eq 0.25mg base/ml
Market Status	Prescription
Company	Emd Serono

2 of 2
Drug Name	Cetrotide
PubMed Health	Cetrorelix (Injection)
Drug Classes	Endocrine-Metabolic Agent
Active Ingredient	Cetrorelix
Dosage Form	Injectable
Route	Injection
Strength	eq 0.25mg base/ml
Market Status	Prescription
Company	Emd Serono

4.2 Therapeutic Uses

Cetrorelix is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation.

Novak, K.M. (ed.). Drug Facts and Comparisons2008 Edition. Wolters Kluwer Health. St. Louis, Missouri 2008., p. 353

/EXPL THER/ This randomized, placebo-controlled, single-blind, experimental study was performed on 45 Wistar adult female rats ... . After the peritoneal implantation of endometrial tissue, rats were randomized to three equal intervention groups: (i) control group, (ii) leuprolide group, and (iii) cetrorelix group. Six weeks later, following implant volume measurements (volume-1) by performing a second laparotomy, saline (0.1 mL/rat) was administered subcutaneously to the control group once a week, leuprolide (0.075 mg/kg) subcutaneously to the leuprolide group twice at 4-week intervals and cetrorelix (0.001 mg/rat/day) subcutaneously to the cetrorelix group for 8 weeks. At the end of the treatment, by performing a third laparotomy, implant volumes were remeasured (volume-2) and implants were totally excised for histopathological examination. The volume-1 and volume-2 values within the groups, and stromal and glandular tissue scores between the groups were compared. In both the leuprolide group and the cetrorelix group, volume-2 as compared to volume-1 had significantly reduced (P < 0.01, P < 0.01 respectively), while there was no significant volume change in the control group (P > 0.05). In this group, when compared with the control group, glandular and stromal tissues had significantly lessened (P < 0.01, P < 0.01 respectively). Leuprolide and cetrorelix were found to have similar efficacy in the regression of both the size and the histological structure of experimental endometriotic implants.

PMID:19012701 Altintas D et al; J Obstet Gynaecol Res 34 (6): 1014-9 (2008)

4.3 Drug Warning

Cetrorelix should be prescribed by health care providers who are experienced in fertility treatment. Before starting treatment with cetrorelix acetate, pregnancy must be excluded.

Novak, K.M. (ed.). Drug Facts and Comparisons2008 Edition. Wolters Kluwer Health. St. Louis, Missouri 2008., p. 354

Elevations in liver function test results including ALT (SGPT), AST (SGOT), gamma-glutamyltransferase (GGT, gamma-glutamyl transpeptidase, GGTP), and alkaline phosphatase up to 3 times the upper limit of normal were reported in 1-2% of patients receiving cetrorelix during controlled ovarian stimulation.

Caution is advised in patients with hypersensitivity to GnRH. Carefully monitor these patients after the first injection. A severe anaphylactic reaction associated with cough, rash, and hypotension was observed in 1 patient after 7 months of treatment with 10 mg/day cetrorelix in a study for an indication unrelated to infertility.

Novak, K.M. (ed.). Drug Facts and Comparisons2008 Edition. Wolters Kluwer Health. St. Louis, Missouri 2008., p. 353

Local site reactions (e.g. redness, erythema, bruising, itching, swelling and pruritus) were reported. Usually, they were of a transient nature, mild intensity and short duration.

US Natl Inst Health; DailyMed. Current Medication Information for Cetrotide (Cetrorelix acetate) (April 2008). Available from, as of February 9, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=7634

For more Drug Warnings (Complete) data for CETRORELIX (8 total), please visit the HSDB record page.

4.4 Drug Indication

For the inhibition of premature LH surges in women undergoing controlled ovarian stimulation

FDA Label

Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques.

In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Cetrorelix is a synthetic decapeptide with gonadotropin-releasing hormone (GnRH) antagonistic activity. GnRH induces the production and release of luteinizing hormone (LH) and follicle stimulating hormone (FSH) from the gonadotrophic cells of the anterior pituitary. Due to a positive estradiol (E2) feedback at midcycle, GnRH liberation is enhanced resulting in an LH-surge. This LH-surge induces the ovulation of the dominant follicle, resumption of oocyte meiosis and subsequently luteinization as indicated by rising progesterone levels. Cetrorelix competes with natural GnRH for binding to membrane receptors on pituitary cells and thus controls the release of LH and FSH in a dose-dependent manner.

5.2 MeSH Pharmacological Classification

Fertility Agents, Female

Compounds which increase the capacity to conceive in females. (See all compounds classified as Fertility Agents, Female.)

Hormone Antagonists

Chemical substances which inhibit the function of the endocrine glands, the biosynthesis of their secreted hormones, or the action of hormones upon their specific sites. (See all compounds classified as Hormone Antagonists.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

CETRORELIX

5.3.2 FDA UNII

OON1HFZ4BA

5.3.3 Pharmacological Classes

Mechanisms of Action [MoA] - Gonadotropin Releasing Hormone Receptor Antagonists

5.4 ATC Code

H01CC02

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

H - Systemic hormonal preparations, excl. sex hormones and insulins

H01 - Pituitary and hypothalamic hormones and analogues

H01C - Hypothalamic hormones

H01CC - Anti-gonadotropin-releasing hormones

H01CC02 - Cetrorelix

5.5 Absorption, Distribution and Excretion

Absorption

Rapidly absorbed following subcutaneous injection. The mean absolute bioavailability following subcutaneous administration to healthy female subjects is 85%.

Route of Elimination

Following subcutaneous administration of 10 mg cetrorelix to males and females, only unchanged cetrorelix was detected in urine.

Volume of Distribution

1.16 L/kg

Clearance

1.28 ml/minkg [adult healthy female with 3 mg single SC administration]

Following subcutaneous administration of 10 mg cetrorelix to males and females, only unchanged cetrorelix was detected in urine. In 24 hours, cetrorelix and small amounts of the (1-9), (1-7), (1-6), and (1-4) peptides were found in bile samples. 2-4% of the dose was eliminated in the urine as unchanged cetrorelix, while 5-10% was eliminated as cetrorelix and the four metabolites in bile. Therefore, only 7-14% of the total dose was recovered as unchanged cetrorelix and metabolites in urine and bile up to 24 hours. The remaining portion of the dose may not have been recovered since bile and urine were not collected for a longer period of time.

The volume of distribution of Cetrotide following a single intravenous dose of 3 mg is about 1 L/kg. In vitro protein binding to human plasma is 86%. Cetrotide concentrations in follicular fluid and plasma were similar on the day of oocyte pick-up in patients undergoing controlled ovarian stimulation. Following subcutaneous administration of Cetrotide 0.25 mg and 3 mg, plasma concentrations of cetrorelix were below or in the range of the lower limit of quantitation on the day of oocyte pick-up and embryo transfer.

Cetrotide is rapidly absorbed following subcutaneous injection, maximal plasma concentrations being achieved approximately one to two hours after administration. The mean absolute bioavailability of Cetrotide following subcutaneous administration to healthy female subjects is 85%.

Pharmacokinetic studies were performed predominantly in rats and dogs. Absorption from the sc injection site was rapid and complete and there were no differences in absorption with regard to sex or species. A linear relationship between dose and plasma AUC was evident. Distribution of cetrorelix was rapid. Main target organs were the kidney, liver, small intestine and organs containing the luteinising hormone releasing hormone (LHRH) receptor (pituitary gland, ovaries). Plasma protein binding amounted to 86%. Elimination from most tissues was rapid and occurred predominantly within 48 hr. ... Cetrorelix crosses the placenta only to a low extent. The distribution of cetrorelix or its metabolites into milk was not investigated. Cetrorelix is excreted unchanged into urine and after metabolism by peptidases into bile. ... Studies in healthy volunteers indicate that cetrorelix is excreted in a similar manner in humans, rats and dogs.

European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, European Public Assessment Report (EPAR) for Authorized Medicinal Products for Human Use; Cetrotide, Scientific Discussion (2003). Available from, as of February 15, 2009: https://www.emea.europa.eu/humandocs/PDFs/EPAR/Cetrotide/297998en6.pdf

Following subcutaneous injection, the absolute bioavailability of cetrorelix was approximately 85% in both males and females. The apparent volume of distribution was 1.16 + or - 0.29 L/kg in females and 1.02 + or - 0.33 L/kg in males. The terminal half-life was about 10 hours after iv and 30 hours after subcutaneous injection with a trend towards lower values in female. Protein binding in human plasma was around 85%. Linear pharmacokinetics were observed following both single (0.25, 0.5 and 1.00 mg) and multiple dose administration (0.25 to 1.00 mg). The pharmacokinetics were linear up to a 3 mg dose.

5.6 Metabolism/Metabolites

In in vitro studies, cetrorelix was stable against phase I- and phase II-metabolism. Cetrorelix was transformed by peptidases, and the (1-4) peptide was the predominant metabolite.

The main metabolite of cetrorelix in the rat bile was identified as being the heptapeptide (1-7). The metabolite was pharmacologically inactive in rats, in terms of testosterone suppression.

After subcutaneous administration of 10 mg Cetrotide to females and males, Cetrotide and small amounts of (1-9), (1-7), (1-6), and (1-4) peptides were found in bile samples over 24 hours. In in vitro studies, Cetrotide was stable against phase I- and phase II-metabolism. Cetrotide was transformed by peptidases, and the (1-4) peptide was the predominant metabolite.

5.7 Biological Half-Life

~62.8 hours

In humans, the terminal half-life values after iv and sc administration were 8-9 hr and 24-40 hr, respectively.

The terminal half-lives in rats after iv and sc administration were 1-2 hr and 7-14 hr, respectively ... .

Elimination half life: Single 3 mg dose: 62.8 hr (38.2-108 hr); Single 0.25 mg dose: 5.0 hr (2.4-48.8 hr); 0.25 mg daily for 14 days: dose: 20.6 hr (4.1-179.3 hr) /From table/

Half-lives of greater than or equal to 100 hr were observed mainly in organs of elimination (liver, kidney), spleen and in the organs containing LHRH binding sites.

5.8 Mechanism of Action

Cetrorelix binds to the gonadotropin releasing hormone receptor and acts as a potent inhibitor of gonadotropin secretion. It competes with natural GnRH for binding to membrane receptors on pituitary cells and thus controls the release of LH and FSH in a dose-dependent manner.

Cetrotide competes with natural GnRH for binding to membrane receptors on pituitary cells and thus controls the release of LH and FSH in a dose-dependent manner. The onset of LH suppression is approximately one hour with the 3 mg dose and two hours with the 0.25 mg dose. This suppression is maintained by continuous treatment and there is a more pronounced effect on LH than on FSH. An initial release of endogenous gonadotropins has not been detected with Cetrotide, which is consistent with an antagonist effect.

GnRH induces the production and release of luteinizing hormone (LH) and follicle stimulating hormone (FSH) from the gonadotrophic cells of the anterior pituitary. Due to a positive estradiol (E2) feedback at midcycle, GnRH liberation is enhanced resulting in an LH-surge. This LH-surge induces the ovulation of the dominant follicle, resumption of oocyte meiosis and subsequently luteinization as indicated by rising progesterone levels.

The mechanisms through which luteinizing hormone (LH)-releasing hormone (LHRH) antagonists suppress pituitary gonadotroph functions and LHRH-receptor (LHRH-R) expression are incompletely understood. Consequently, we investigated the direct effect of LHRH antagonist cetrorelix in vitro on the expression of the pituitary LHRH-R gene and its ability to counteract the exogenous LHRH and the agonist triptorelin in the regulation of this gene. We also compared the effects of chronic administration of cetrorelix and triptorelin on the LHRH-R mRNA level and gonadotropin secretion in ovariectomized (OVX) and normal female rats. The exposure of pituitary cells in vitro to 3-min pulses of 1 nM LHRH or 0.1 nM triptorelin for 5 hr increased the LHRH-R mRNA level by 77-88%. Continuous perfusion of the cells with 50 nM cetrorelix did not cause any significant changes, but prevented the stimulatory effect of LHRH pulses on the receptor mRNA expression. In OVX rats, 10 days after administration of a depot formulation of cetrorelix, releasing 100 microg of peptide daily, the elevated LHRH-R mRNA level was decreased by 73%, whereas daily injection of 100 microg of triptorelin caused a 41% suppression. In normal female rats, cetrorelix treatment suppressed the LHRH-R mRNA level by 33%, but triptorelin increased it by 150%. The highly elevated serum LH levels in OVX rats and the normal LH concentration of cycling rats were rapidly and completely suppressed by cetrorelix. Triptorelin decreased the serum LH in OVX rats to the precastration level, but had no effect on basal LH in normal rats. Our results confirm that LHRH antagonists, such as cetrorelix, inhibit the gene expression of pituitary LHRH-R indirectly, by counteracting the stimulatory effect of LHRH. A rapid suppression of serum LH by LHRH antagonists would be advantageous in the treatment of sex hormone-dependent tumors and other conditions.

PMID:11593037 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC59791 Kovacs M, Schally AV; Proc Natl Acad Sci U S A 98 (21): 12197-202 (2001)

Cetrorelix binds with high affinity to luteinising hormone releasing hormone (LHRH) receptors, and labelled LHRH was shown to be displaced from the two classes of LHRH receptors by the compound. In vitro, cetrorelix dose-dependently inhibited the LHRH-mediated LH release in perfused rat pituitary cell systems. Further, in a recently established in vitro assay, cetrorelix proved to be a high affinity antagonist at the LHRH-receptor and dose-dependently blocked the signal transduction induced by LHRH.

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API Reference Price

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MOSES ROAD, MAHALAXMI,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1635100200,"product":"CETRORELIX POWDER (SYNTHETIC) (AS ACETAT","address":"114, TURF ESTATE, 3\/65, OFF DR.E. MOSES ROAD, MAHALAXMI,","city":"MUMBAI, MAHARASHTRA","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"INDIA","foreign_port":"TEHRAN","customer":"TO THE ORDER\"","customerCountry":"IRAN","quantity":"0.04","actualQuantity":"41","unit":"GMS","unitRateFc":"1096","totalValueFC":"51473.7","currency":"EUR","unitRateINR":94048.780487804877,"date":"25-Oct-2021","totalValueINR":"3856000","totalValueInUsd":"51473.7","indian_port":"BOMBAY AIR","hs_no":"29371900","bill_no":"5531427","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"IRAN","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"114, TURF ESTATE, 3\/65, OFF DR.E. MOSES ROAD, MAHALAXMI,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649269800,"product":"CETRORELIX ACETATE WITH WS AND IMPURITIE","address":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA","city":"VADODARA,GUJARAT","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"M\/S APICORE US LLC","customerCountry":"UNITED STATES","quantity":"0.00","actualQuantity":"0.5","unit":"GMS","unitRateFc":"2000","totalValueFC":"994.1","currency":"USD","unitRateINR":150000,"date":"07-Apr-2022","totalValueINR":"75000","totalValueInUsd":"994.1","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"9536029","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA, VADODARA,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649269800,"product":"CETRORELIX ACETATE WITH WS AND IMPURITIE","address":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA","city":"VADODARA,GUJARAT","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"M\/S APICORE US LLC","customerCountry":"UNITED STATES","quantity":"0.00","actualQuantity":"2.5","unit":"GMS","unitRateFc":"2000","totalValueFC":"4983.5","currency":"USD","unitRateINR":150400,"date":"07-Apr-2022","totalValueINR":"376000","totalValueInUsd":"4983.5","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"9536029","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA, VADODARA,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1656354600,"product":"CETRORELIX ACETATE (IN-HOUSE) 35 G","address":"114, TURF ESTATE, 3\/65, OFF DR. E. MOSES ROAD, MAHALAXMI,","city":"MUMBAI, MAHARASHTRA","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"INDIA","foreign_port":"TEHRAN","customer":"VARIAN PHARMED","customerCountry":"IRAN","quantity":"0.04","actualQuantity":"35","unit":"GMS","unitRateFc":"1100","totalValueFC":"39530.7","currency":"EUR","unitRateINR":88114.28571428571,"date":"28-Jun-2022","totalValueINR":"3084000","totalValueInUsd":"39530.7","indian_port":"BOMBAY AIR","hs_no":"29371900","bill_no":"2437250","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"IRAN","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"114, TURF ESTATE, 3\/65, OFF DR. E. MOSES ROAD, MAHALAXMI,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674066600,"product":"CETRORELIX ACETATE, BATCH NO:CTRX\/21\/05\/","address":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA","city":"VADODARA,GUJARAT","supplier":"VIATRIS","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"RK PHARMA","customerCountry":"UNITED STATES","quantity":"0.01","actualQuantity":"7","unit":"GMS","unitRateFc":"2000","totalValueFC":"14029","currency":"USD","unitRateINR":163857.14285714287,"date":"19-Jan-2023","totalValueINR":"1147000","totalValueInUsd":"14029","indian_port":"AHMEDABAD AIR","hs_no":"29371900","bill_no":"7090769","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"BLOCK NO.252-253, VILLAGE DHOBIKUV A,PADRA JAMBUSAR HIGHWAY TAL PADRA, VADODARA,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701282600,"product":"CETRORELIX (AS ACETATE)POWDER (SYNTHETIC)","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"TO THE ORDER","customerCountry":"TURKEY","quantity":"0.05","actualQuantity":"50","unit":"GMS","unitRateFc":"1104","totalValueFC":"58303.7","currency":"EUR","unitRateINR":97100,"date":"30-Nov-2023","totalValueINR":"4855000","totalValueInUsd":"58303.7","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"5711347","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK, KURLA, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703874600,"product":"CETRORELIX POWDER (SYNTHETIC)","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"PRIME BANK LTD","customerCountry":"BANGLADESH","quantity":"0.00","actualQuantity":"3","unit":"GMS","unitRateFc":"1500","totalValueFC":"4348.7","currency":"USD","unitRateINR":120666.66666666667,"date":"30-Dec-2023","totalValueINR":"362000","totalValueInUsd":"4348.7","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"6424246","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK, KURLA, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710441000,"product":"CETRORELIX POWDER (SYNTHETIC)","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"TO THE ORDER","customerCountry":"SPAIN","quantity":"0.01","actualQuantity":"14","unit":"GMS","unitRateFc":"5000","totalValueFC":"67820.7","currency":"USD","unitRateINR":402253,"date":"15-Mar-2024","totalValueINR":"5631542","totalValueInUsd":"67820.7","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"8349270","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK, KURLA, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717007400,"product":"CETRORELIX POWDER (SYNTHETIC)QTY 104.5 G","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"GP PHARM","customerCountry":"SPAIN","quantity":"0.10","actualQuantity":"104.5","unit":"GMS","unitRateFc":"1600","totalValueFC":"165787.5","currency":"USD","unitRateINR":132240,"date":"30-May-2024","totalValueINR":"13819080","totalValueInUsd":"165787.5","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"1277859","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK, KURLA, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733682600,"product":"CETRORELIX (AS ACETATE) POWDER (SYNTHETIC) QTY: 50 G","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"TO THE ORDER","customerCountry":"TURKEY","quantity":"0.05","actualQuantity":"50","unit":"GMS","unitRateFc":"1096.2","totalValueFC":"56440.5","currency":"EUR","unitRateINR":95913.899999999994,"date":"09-Dec-2024","totalValueINR":"4795695","totalValueInUsd":"56440.5","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"6280983","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK, KURLA, MUMBAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"CETRORELIX ACETATE","year":"2021","qtr":"Q1","strtotime":1612981800,"product":"CETRORELIX ACETATE 500MG X 2 PACK & 1GRAM X 2 PACK LOT NO.1031200701 ( 3 GRAM )","address":"B613 EMPIRE BUSINESS HUB,OPP SHAKT I,FARM, SCEINCE CITY ROAD, SOLA","city":"AHMEDABAD,GUJARAT","supplier":"ALP PHARM","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"AMERISE PHARMACEUTICALS PRIVATE ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.003","unit":"KGS","unitRateFc":"3000000","totalValueFC":"10237.8","currency":"USD","unitRateINR":"248460000","date":"11-Feb-2021","totalValueINR":"745380","totalValueInUsd":"10237.8","indian_port":"AHMEDABAD AIR","hs_no":"29379090","bill_no":"2728738","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"","customerAddress":"B613 EMPIRE BUSINESS HUB,OPP SHAKT I,FARM, SCEINCE CITY ROAD, SOLA"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1626805800,"product":"CETRORELIX ACETATE(FOR TESTING PURPOSE ONLY)","address":"159, C.S.T. ROAD,KALINA, SANTACRUZ (E)","city":"MUMBAI,MAHARASHTRA","supplier":"HYBIO PHARMACEUTICAL (WUHAN) CO LTD","supplierCountry":"CHINA","foreign_port":"GUANGZHOU","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"3","unit":"GMS","unitRateFc":"2000","totalValueFC":"9105.5","currency":"USD","unitRateINR":"226200","date":"21-Jul-2021","totalValueINR":"678600","totalValueInUsd":"9105.5","indian_port":"BOMBAY AIR","hs_no":"29371900","bill_no":"4753474","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"GUANGZHOU","supplierAddress":"","customerAddress":"159, C.S.T. ROAD,KALINA, SANTACRUZ (E)"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1635705000,"product":"CETRORELIX ACETATE API(FOR TESTING PURPOSE ONLY)","address":"Kalpataru Inspire, 3rd floor, off Western Express Highway Santacruz E","city":"Mumbai","supplier":"HYBIO PHARMACEUTICAL (WUHAN) CO LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"2000","totalValueFC":"22705.7","currency":"USD","unitRateINR":"169092.3","date":"01-Nov-2021","totalValueINR":"1690923.08","totalValueInUsd":"22705.7","indian_port":"BOMBAY AIR","hs_no":"29371900","bill_no":"6088417","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Kalpataru Inspire, 3rd floor, off Western Express Highway Santacruz E"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1650220200,"product":"CETRORELIX","address":"5-5-35\/102&103,PLOT NO 22,23,SY NO ,379,380,381,PRASHANTH NAGAR,KP","city":"HYDERABAD,TELANGANA","supplier":"M\/S. CHINESE PEPTIDE CO.,LTD.","supplierCountry":"CHINA","foreign_port":"NA","customer":"EXTROVIS AG","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"2","unit":"GMS","unitRateFc":"1450","totalValueFC":"3646.8","currency":"USD","unitRateINR":"137571.9","date":"18-Apr-2022","totalValueINR":"275143.88","totalValueInUsd":"3646.8","indian_port":"HYDERABAD AIR","hs_no":"29371900","bill_no":"8321053","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"5-5-35\/102&103,PLOT NO 22,23,SY NO ,379,380,381,PRASHANTH NAGAR,KP"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1693161000,"product":"CETRORELIX ACETATE","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER PAREL","city":"MUMBAI","supplier":"SINOPEPALLSINO BIOPHARMACETIC","supplierCountry":"CHINA","foreign_port":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"2200","totalValueFC":"12681.1","currency":"USD","unitRateINR":"207990.7","date":"28-Aug-2023","totalValueINR":"1050458.204","totalValueInUsd":"12681.1","indian_port":"SAHAR AIR","hs_no":"29379090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER PAREL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723833000,"product":"CETRORELIX ACETATE WS (1000 MG)","address":"407\/408,SHARDA CHAMBERS,","city":"MUMBAI, MAHARASHTRA.","supplier":"M\/S. SINOPEP-ALLSINO BIOPHARMACEUTICAL CO.,LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"BDR PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"1","unit":"GMS","unitRateFc":"7500","totalValueFC":"7586.9","currency":"USD","unitRateINR":"636375","date":"17-Aug-2024","totalValueINR":"636375","totalValueInUsd":"7586.9","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"5112217","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.28 LINPU ROAD LIANYUNGANGINDUSTRIAL AREA ECO AND TECHDEVELOPMENT ZONE JIANGSU,222000 CN","customerAddress":"407\/408,SHARDA CHAMBERS,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - POWDER;SUBCUTANEOUS - EQ 0.25MG BASE...DOSAGE - POWDER;SUBCUTANEOUS - EQ 0.25MG BASE/VIAL

USFDA APPLICATION NUMBER - 21197

DOSAGE - POWDER;SUBCUTANEOUS - EQ 3MG BASE/VI...DOSAGE - POWDER;SUBCUTANEOUS - EQ 3MG BASE/VIAL

USFDA APPLICATION NUMBER - 21197

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ABOUT THIS PAGE

Cetrorelix Acetate Manufacturers

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

Cetrorelix Acetate Suppliers

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

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

Cetrorelix Acetate USDMF

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

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

click here to find a list of Cetrorelix Acetate suppliers with USDMF on PharmaCompass.

Cetrorelix Acetate 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 Cetrorelix Acetate Drug Master File in Japan (Cetrorelix Acetate JDMF) empowers Cetrorelix Acetate 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 Cetrorelix Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Cetrorelix Acetate 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 Cetrorelix Acetate suppliers with JDMF on PharmaCompass.

Cetrorelix Acetate WC

A Cetrorelix Acetate written confirmation (Cetrorelix Acetate WC) is an official document issued by a regulatory agency to a Cetrorelix Acetate manufacturer, verifying that the manufacturing facility of a Cetrorelix Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cetrorelix Acetate APIs or Cetrorelix Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Cetrorelix Acetate WC (written confirmation) as part of the regulatory process.

click here to find a list of Cetrorelix Acetate suppliers with Written Confirmation (WC) on PharmaCompass.

Cetrorelix Acetate 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 Cetrorelix Acetate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cetrorelix Acetate 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 Cetrorelix Acetate 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 Cetrorelix Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cetrorelix Acetate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Cetrorelix Acetate suppliers with NDC on PharmaCompass.

Cetrorelix Acetate GMP

Cetrorelix Acetate 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 Cetrorelix Acetate 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 Cetrorelix Acetate GMP manufacturer or Cetrorelix Acetate GMP API supplier for your needs.

Cetrorelix Acetate CoA

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

Cetrorelix Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Cetrorelix Acetate 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.

Cetrorelix Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Cetrorelix Acetate EP), Cetrorelix Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cetrorelix Acetate 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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