Sun Pharmaceutical Industries Ltd.

FDA establishment 3002809586, Halol, India. Part of Sun Pharmaceutical Industries's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, its recalls since 2016, and the shipments FDA refused at the border.

Inspections: 12
Official action indicated: 5
Last inspection ended: Jun 13, 2025
Warning letters: 1
Recalls since 2016: 1
Import refusals since 2024: 48
Import refusals 2014 to 2023: 71, first Oct 21, 2022

Inspections by Fiscal Year

FY2018 to FY2027 to date; 3 classified OAI

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

22019

02021

02023

12025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

12 inspections, newest first


Jun 13, 2025	Drugs · Drug Quality Assurance	8 cited references 21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. 21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. 21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. 21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product. 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. 21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. 21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.	Official Action Indicated (OAI)
May 9, 2022	Drugs · Drug Quality Assurance	10 cited references 21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. 21 CFR 211.42(c)(10). Aseptic Processing Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products. 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. 21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. 21 CFR 211.166(a). Written program not followed The written stability testing program is not followed. 21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions. 21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed. 21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance. 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.	Official Action Indicated (OAI)
Dec 13, 2019	Drugs · Drug Quality Assurance	8 cited references 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. 21 CFR 211.110(a). Written in-process control procedures Written procedures are not established and followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch. 21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. 21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. 21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. 21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. 21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.	Official Action Indicated (OAI)
Jun 11, 2019	Devices · Compliance: DevicesDrugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
Dec 6, 2018	Drugs · Drug Quality Assurance	None posted	No Action Indicated (NAI)
Aug 31, 2018	Drugs · Drug Quality Assurance	None posted	No Action Indicated (NAI)
Feb 23, 2018	Drugs · Drug Quality Assurance	3 cited references 21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance. 21 CFR 211.42(c)(10). Aseptic Processing Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products. 21 CFR 211.80(a). Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the sampling, testing, approval and rejection of drug product containers and closures.	Voluntary Action Indicated (VAI)
Dec 1, 2016	Drugs · Drug Quality Assurance	None posted	Official Action Indicated (OAI)
Sep 16, 2014	Drugs · Drug Quality Assurance	None posted	Official Action Indicated (OAI)
Sep 28, 2012	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
Jun 13, 2012	Drugs · Drug Quality Assurance	None posted	Voluntary Action Indicated (VAI)
Apr 7, 2011	Drugs · Drug Quality Assurance	None posted	No Action Indicated (NAI)

Warning Letters

Letters naming this establishment; each opens the letter

Aseptic processing, Sterility assurance, Cleaning validationOct 16, 2023

Recalls

1 drug, device and biologic recalls since 2016, newest first; 0 Class I

Recalled product	Class	Classified
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL…Drug · D-0569-2023	Class II	Apr 19, 2023

Import Refusals

48 refused shipment lines since 2024, grouped by product and charges


ROSUVASTATIN CALCIUMDrugs · 61JCH16	Drug made outside good manufacturing practiceUnapproved new drug	Oct 2, 2026
ESCITALOPRAM OXALATEDrugs · 61NCA83	Drug made outside good manufacturing practice	Sep 30, 20263 lines
LETROZOLE (ANTI-NEOPLASTIC)Drugs · 62ICA85	Drug made outside good manufacturing practiceUnapproved new drug	Jul 24, 2026
LETROZOLE (ANTI-NEOPLASTIC)Drugs · 62ICA85	Drug made outside good manufacturing practice	Jul 7, 20262 lines
ANTI-HISTAMINIC N.E.C.Drugs · 61XDY99	Unapproved new drug	Jun 26, 2026
LEUPROLIDE ACETATE (ANTI-NEOPLASTIC)Drugs · 62ICY86	Drug made outside good manufacturing practice	Apr 24, 2026
CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANTDrugs · 64DDY01	Drug made outside good manufacturing practiceUnapproved new drug	Nov 25, 2025
TOBRAMYCIN (ANTI-MICROBIAL)Drugs · 62HDY02	Drug made outside good manufacturing practiceUnapproved new drug	Nov 25, 2025
ANTI-NEOPLASTIC N.E.C.Drugs · 62ICA99	Unapproved new drug	Aug 13, 2025
METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II)Drugs · 62OCY43	Drug made outside good manufacturing practice	Jun 26, 20252 lines
MONTELUKAST SODIUM (ANTI-ASTHMATIC)Drugs · 61EBY09	Drug made outside good manufacturing practice	Jun 11, 20253 lines
ANALGESIC, N.E.C.Drugs · 60LCA99	Drug made outside good manufacturing practice	Jun 11, 2025
TIMOLOL MALEATE (ANTI-ADRENERGIC)Drugs · 60XDY23	Drug made outside good manufacturing practice	Jun 5, 2025
IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)Drugs · 62LCA47	Drug made outside good manufacturing practiceUnapproved new drug	Jun 4, 2025
ADRENERGIC N.E.C.Drugs · 60CDB99	Unapproved new drug	Apr 14, 2025
BUDESONIDE (ANTI-ASTHMATIC)Drugs · 61ECE04	Drug made outside good manufacturing practice	Apr 3, 2025
BUDESONIDE (ANTI-ASTHMATIC)Drugs · 61ECY04	Drug made outside good manufacturing practice	Feb 27, 2025
ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)Drugs · 61WCY46	Drug made outside good manufacturing practice	Jan 16, 2025
ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.Drugs · 66PDO99	Drug made outside good manufacturing practice	Jan 16, 2025
ROSUVASTATIN CALCIUMDrugs · 61JCY16	Drug made outside good manufacturing practice	Jan 10, 2025
ROSUVASTATIN CALCIUMDrugs · 61JCA16	Drug made outside good manufacturing practice	Nov 27, 20242 lines
IMATINIB MESYLATE (IMMUNOSUPPRESSIVE)Drugs · 64TCA09	Drug made outside good manufacturing practice	Oct 17, 2024
ROSUVASTATIN CALCIUMDrugs · 61JCA16	Drug made outside good manufacturing practiceUnapproved new drug	Oct 7, 2024
ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)Drugs · 62TDB06	Drug made outside good manufacturing practiceUnapproved new drug	Oct 1, 2024
ANTI-INFLAMMATORY N.E.C.Drugs · 62GCA99	Unapproved new drug	Sep 27, 2024
ANTACID, N.E.C.Drugs · 60SCS99	Drug made outside good manufacturing practice	Sep 27, 2024
ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)Drugs · 61JDC08	Drug made outside good manufacturing practice	Jul 25, 2024
ANTI-CHOLESTEREMIC, N.E.C.Drugs · 61JDB99	Drug made outside good manufacturing practice	Jul 23, 2024
DIGOXIN (CARDIOTONIC)Drugs · 63FCA06	Drug made outside good manufacturing practice	Jul 17, 2024
ETHINYL ESTRADIOL (ESTROGEN)Drugs · 64GDC19	Unapproved new drug	Jul 16, 2024
RIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)Drugs · 61FCA63	Drug made outside good manufacturing practice	May 28, 2024
CALCIUM CHLORIDE (REPLENISHER)Drugs · 65RDY01	Drug made outside good manufacturing practice	May 24, 2024
GLIMEPIRIDE (ANTI-DIABETIC)Drugs · 61PDC31	Drug made outside good manufacturing practice	May 16, 2024
PAROXETINE (ANTI-DEPRESSANT)Drugs · 61NCE76	Drug made outside good manufacturing practice	May 14, 2024
QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)Drugs · 66NCA03	Drug made outside good manufacturing practice	May 6, 2024
ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)Drugs · 62TCS06	Drug made outside good manufacturing practice	Apr 24, 2024
ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)Drugs · 61JIY08	Drug made outside good manufacturing practice	Apr 17, 2024
ANTI-INFLAMMATORY N.E.C.Drugs · 62GCA99	Drug made outside good manufacturing practice	Mar 21, 2024
NAPROXEN (ANTI-INFLAMMATORY)Drugs · 62GIC49	Drug made outside good manufacturing practice	Mar 15, 2024
CLOPIDOGREL BISULFATE (ANTI-COAGULANT)Drugs · 61LDA38	Drug made outside good manufacturing practice	Mar 15, 2024
AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)Drugs · 56BCA03	Drug made outside good manufacturing practice	Feb 22, 2024

Identifiers

FEI number: 3002809586
FDA firm profile: Data Dashboard
Inspection program: 7356.002, Drug Manufacturing Inspections
Company: Sun Pharmaceutical Industries

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports

Jun 13, 2025

Drugs · Drug Quality Assurance

8 cited references

21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.

Official Action Indicated (OAI)

May 9, 2022

Drugs · Drug Quality Assurance

10 cited references

21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.42(c)(10). Aseptic Processing Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

Official Action Indicated (OAI)

Dec 13, 2019

Drugs · Drug Quality Assurance

8 cited references

21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.110(a). Written in-process control procedures Written procedures are not established and followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Official Action Indicated (OAI)

Jun 11, 2019

Devices · Compliance: DevicesDrugs · Drug Quality Assurance

None posted

Voluntary Action Indicated (VAI)

Dec 6, 2018

Drugs · Drug Quality Assurance

None posted

No Action Indicated (NAI)

Aug 31, 2018

Drugs · Drug Quality Assurance

None posted

No Action Indicated (NAI)

Feb 23, 2018

Drugs · Drug Quality Assurance

3 cited references

21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance.
21 CFR 211.42(c)(10). Aseptic Processing Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
21 CFR 211.80(a). Procedures To Be in Writing Written procedures are lacking which describe in sufficient detail the sampling, testing, approval and rejection of drug product containers and closures.

Voluntary Action Indicated (VAI)

Dec 1, 2016

Drugs · Drug Quality Assurance

None posted

Official Action Indicated (OAI)

Sep 16, 2014

Drugs · Drug Quality Assurance

None posted

Official Action Indicated (OAI)

Sep 28, 2012

Drugs · Drug Quality Assurance

None posted

Voluntary Action Indicated (VAI)

Jun 13, 2012

Drugs · Drug Quality Assurance

None posted

Voluntary Action Indicated (VAI)

Apr 7, 2011

Drugs · Drug Quality Assurance

None posted

No Action Indicated (NAI)

Recalled product

Class

Classified

Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL…Drug · D-0569-2023

Class II

Apr 19, 2023

ROSUVASTATIN CALCIUMDrugs · 61JCH16

Drug made outside good manufacturing practiceUnapproved new drug

Oct 2, 2026

ESCITALOPRAM OXALATEDrugs · 61NCA83

Drug made outside good manufacturing practice

Sep 30, 20263 lines

LETROZOLE (ANTI-NEOPLASTIC)Drugs · 62ICA85

Drug made outside good manufacturing practiceUnapproved new drug

Jul 24, 2026

LETROZOLE (ANTI-NEOPLASTIC)Drugs · 62ICA85

Drug made outside good manufacturing practice

Jul 7, 20262 lines

ANTI-HISTAMINIC N.E.C.Drugs · 61XDY99

Unapproved new drug

Jun 26, 2026

LEUPROLIDE ACETATE (ANTI-NEOPLASTIC)Drugs · 62ICY86

Drug made outside good manufacturing practice

Apr 24, 2026

CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANTDrugs · 64DDY01

Drug made outside good manufacturing practiceUnapproved new drug

Nov 25, 2025

TOBRAMYCIN (ANTI-MICROBIAL)Drugs · 62HDY02

Drug made outside good manufacturing practiceUnapproved new drug

Nov 25, 2025

ANTI-NEOPLASTIC N.E.C.Drugs · 62ICA99

Unapproved new drug

Aug 13, 2025

METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II)Drugs · 62OCY43

Drug made outside good manufacturing practice

Jun 26, 20252 lines

MONTELUKAST SODIUM (ANTI-ASTHMATIC)Drugs · 61EBY09

Drug made outside good manufacturing practice

Jun 11, 20253 lines

ANALGESIC, N.E.C.Drugs · 60LCA99

Drug made outside good manufacturing practice

Jun 11, 2025

TIMOLOL MALEATE (ANTI-ADRENERGIC)Drugs · 60XDY23

Drug made outside good manufacturing practice

Jun 5, 2025

IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)Drugs · 62LCA47

Drug made outside good manufacturing practiceUnapproved new drug

Jun 4, 2025

ADRENERGIC N.E.C.Drugs · 60CDB99

Unapproved new drug

Apr 14, 2025

BUDESONIDE (ANTI-ASTHMATIC)Drugs · 61ECE04

Drug made outside good manufacturing practice

Apr 3, 2025

BUDESONIDE (ANTI-ASTHMATIC)Drugs · 61ECY04

Drug made outside good manufacturing practice

Feb 27, 2025

ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)Drugs · 61WCY46

Drug made outside good manufacturing practice

Jan 16, 2025

ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.Drugs · 66PDO99

Drug made outside good manufacturing practice

Jan 16, 2025

ROSUVASTATIN CALCIUMDrugs · 61JCY16

Drug made outside good manufacturing practice

Jan 10, 2025

ROSUVASTATIN CALCIUMDrugs · 61JCA16

Drug made outside good manufacturing practice

Nov 27, 20242 lines

IMATINIB MESYLATE (IMMUNOSUPPRESSIVE)Drugs · 64TCA09

Drug made outside good manufacturing practice

Oct 17, 2024

ROSUVASTATIN CALCIUMDrugs · 61JCA16

Drug made outside good manufacturing practiceUnapproved new drug

Oct 7, 2024

ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)Drugs · 62TDB06

Drug made outside good manufacturing practiceUnapproved new drug

Oct 1, 2024

ANTI-INFLAMMATORY N.E.C.Drugs · 62GCA99

Unapproved new drug

Sep 27, 2024

ANTACID, N.E.C.Drugs · 60SCS99

Drug made outside good manufacturing practice

Sep 27, 2024

ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)Drugs · 61JDC08

Drug made outside good manufacturing practice

Jul 25, 2024

ANTI-CHOLESTEREMIC, N.E.C.Drugs · 61JDB99

Drug made outside good manufacturing practice

Jul 23, 2024

DIGOXIN (CARDIOTONIC)Drugs · 63FCA06

Drug made outside good manufacturing practice

Jul 17, 2024

ETHINYL ESTRADIOL (ESTROGEN)Drugs · 64GDC19

Unapproved new drug

Jul 16, 2024

RIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)Drugs · 61FCA63

Drug made outside good manufacturing practice

May 28, 2024

CALCIUM CHLORIDE (REPLENISHER)Drugs · 65RDY01

Drug made outside good manufacturing practice

May 24, 2024

GLIMEPIRIDE (ANTI-DIABETIC)Drugs · 61PDC31

Drug made outside good manufacturing practice

May 16, 2024

PAROXETINE (ANTI-DEPRESSANT)Drugs · 61NCE76

Drug made outside good manufacturing practice

May 14, 2024

QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)Drugs · 66NCA03

Drug made outside good manufacturing practice

May 6, 2024

ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)Drugs · 62TCS06

Drug made outside good manufacturing practice

Apr 24, 2024

ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)Drugs · 61JIY08

Drug made outside good manufacturing practice

Apr 17, 2024

ANTI-INFLAMMATORY N.E.C.Drugs · 62GCA99

Drug made outside good manufacturing practice

Mar 21, 2024

NAPROXEN (ANTI-INFLAMMATORY)Drugs · 62GIC49

Drug made outside good manufacturing practice

Mar 15, 2024

CLOPIDOGREL BISULFATE (ANTI-COAGULANT)Drugs · 61LDA38

Drug made outside good manufacturing practice

Mar 15, 2024

AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)Drugs · 56BCA03

Drug made outside good manufacturing practice

Feb 22, 2024