CDSCO Drug Alert: 78 Drug Samples including Alkem's Pan 40 Flagged

Written By :  Dr. Divya Colin
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-01-24 12:47 GMT   |   Update On 2024-03-22 16:37 GMT

New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drug Standard Control Organisation (CDSCO) has flagged 78 medicine batches for failing to qualify for a random drug sample test for December– 2023.These include Montelukast Sodium and Levocetirizine Dihydrochloride Tablets manufactured by Bonsai Pharma, Multi-Vitamin Tablets (VITAJACKS-S TABLETS) manufactured...

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New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drug Standard Control Organisation (CDSCO) has flagged 78 medicine batches for failing to qualify for a random drug sample test for December– 2023.

These include Montelukast Sodium and Levocetirizine Dihydrochloride Tablets manufactured by Bonsai Pharma, Multi-Vitamin Tablets (VITAJACKS-S TABLETS) manufactured by Jackson Laboratories, Telmisartan and Amlodipine Tablets IP (Zensartan-AM Tablets) manufactured by Windlass Biotech Limited, Telmisartan Tablets IP 40 mg (Telmibeck-40 Tablets) manufactured by Biocore Pharmaceuticals, Pregabalin Capsules IP (Pragavir Capsules) manufactured by Mayoford Pharma.

Furthermore, the list of drug samples that declared 'Not Of Standard Quality' includes Cyproheptadine HCl and Tricholine Citrate Syrup (CYPOFINE-T Syrup) manufactured by SUNFINE HEALTHCARE, Sodium Valproate manufactured by ZEE LABORATORIES, Aceclofenac, Paracetamol and Serratiopeptidase Tablets (ACETOP- SP TABLETS) manufactured by Yug Enterprises, Cefpodoxime Proxetil Tablets IP (DOXTIL-200 TABLETS) manufactured by Morisus Healthcare, more.

In addition to the above, popular drugs such as Diltizem Tablets IP 60mg manufactured by Skymap Pharmaceuticals and Pantoprazole Gastro-resistant Tablet which is marketed under brand name PAN-40, manufactured by Alkem Health Science are also on the list of samples declared as Not of Standard Quality.

This came after the analysis and tests conducted by the CDSCO Drugs Control Department on 1008 samples. Of these, 930 samples were found to be of standard quality while 78 were declared Not of Standard Quality (NSQ).

A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of uniformity of weight, failure of completeness of solution, clarity of solution and particulate matter, failure of pH, particulate Matter and description.

The samples collected were tested in four laboratories, RDTL Chandigarh, CDL Kolkata, CDTL Mumbai, and RDTL- Guwahati.

List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of December– 2023:

List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of

December– 2023

Total number of samples tested

1008

Total number of samples declared as of Standard Quality

930

The total number of samples declared as Not of Standard Quality

78

The total number of samples declared as Spurious

0

Total number of samples declared as Misbranded

0

S.No

Name of Drugs/medical device/cosmetics

Batch No.

Date of Manufacture

Date of Expiry

Manufactured By

Reason for failure

Drawn By (From

state/CDSCO Zone)

From (Name of Laboratory)

1

Montelukast Sodium and Levocetirizine Dihydrochloride Tablets (MELEE TABLETS)

JUN-23146

Jun-2023

May-2025

Bonsai Pharma, Kishanpura, Baddi-Nalagarh Road, P.O.Gurumajara, Distt. Solan (H.P.)

Assay of Montelukast Sodium Calculated as Montelukast

O/o State Drugs Controller, H.Q. Baddi, H.P.

RDTL

Chandigarh

2

Multi-Vitamin Tablets (VITAJACKS-S TABLETS)

T-171

Apr-2023

Mar-2025

Jackson Laboratories Pvt. Ltd., 22- 24, Majitha Road, Bye Pass, Amritsar-143001 (India)

Assay of Vitamin B1 and Vitamin C.

CDSCO (North Zone), Ghaziabad

RDTL

Chandigarh

3

Telmisartan and Amlodipine Tablets IP (Zensartan-AM Tablets)

WEL22031

Apr-2022

Sep-2024

Windlas Biotech Limited (Plant-2), Khasra No. 141 to 143 & 145., Mohabewala Indl. Area,

Dehradun-248110 (U.K.)

Assay of Amlodipine Besilate calculated as Amlodipine

CDSCO Sub

Zone Baddi,

RDTL

Chandigarh

4

Telmisartan Tablets IP 40 mg (Telmibeck-40 Tablets)

BT23-297

Jul-2023

Jun-2025

Biocore Pharmaceuticals, Plot No. 8-C, D.I.C. Indl. Area, Lodhimajra, Baddi, Distt. Solan (HP)-173205

Dissolution of Telmisartan

CDSCO Sub

Zone Baddi,

RDTL

Chandigarh

5

Pregabalin Capsules IP (Pragavir Capsules)

MMC-1476

Jun-2023

May-2025

Mayoford Pharma, Near Railway Crossing, Chambaghat, Solan, Distt. Solan (H.P.)-173205

Assay of Pregabalin

State FDA, H.Q. Baddi, H.P.

RDTL

Chandigarh


6

Cyproheptadine HCl and Tricholine Citrate Syrup (CYPOFINE-T Syrup)

SHL1107B

Jul-2022

Jun-2024

SUNFINE HEALTCHARE, Plot

No.63, Ind.Area Lodhimajra, Tehsil Baddi, Distt. Solan (H.P.) 1732025

Assay of Tricholine Citrate

State FDA, H.Q. Baddi, H.P.

RDTL

Chandigarh

7

Sodium Valporate Tablets IP 200 mg

423-499

Mar-2023

Feb-2025

ZEE LABORATORIES LTD.,

Behind 47, Industrial Area, Paonta Sahib-173205

Dissolution of Sodium Valproate

State FDA Drugs Control Department, Delhi

RDTL

Chandigarh

8

Aceclofenac, Paracetamol and Serratiopeptidase Tablets (ACETOP- SP TABLETS)

YT206011

Jun-2022

May-2024

Yug Enteprises Pvt. Ltd., Khasra No.143M, Raipur, Bhagwanpur, Roorkee, Distt. haridwar (UK) 247661

Assay of Serratiopeptidase

CDSCO (North Zone), Ghaziabad

RDTL

Chandigarh

9

Cefpodoxime Proxetil Tablets IP (DOXTIL-200 TABLETS)

MHBT/23/03 8

Apr-2023

Mar-2025

Morisus Healthcare, Ind. Area, Bhagwanpur, Roorkee-247661

Uniformity of weight, Identification and Assay of Cefpodoxime Proxetil equivalent to anhydrous Cefpodoxime

State FDA, H.Q.Baddi, HP

RDTL

Chandigarh

10

Ampicillin Capsules IP 500 mg (Ampicillin-500 Capsules)

RRCF 002

May-2023

Apr-2025

Ross Robinz Biotech, (Manufactured under technical guidance of ) ASHICON REMEDIES V.P.O-Barog, Solan - 173212 (H.P.)

Assay of Ampicillin Trihydrate calculated as Ampicillin

State FDA, H.Q.Baddi, HP

RDTL

Chandigarh

11

Amoxycillin Trihydrate Capsules IP (Amoxus -500 Capsules)

CP04854

Jun-2023

May-2025

Morisus Healthcare, Ind. Area, Bhagwanpur, Roorkee-247661

Identification, Uniformity of filled weight and Assay of

Amoxycillin

O/o State Drugs Controller, H.Q. Baddi, HP

RDTL

Chandigarh


trihydrate eq. to Amoxycillin

12

Azithromycin Tablets IP 500 mg (Zathron-500 Tablets)

45865

Mar-2023

Feb-2025

Reon Pharma, Plot No. F-310, Road No-3, Phase-1st Kathwad, Gidc Bhind Odhav Vepan, Ahmedabad (Gujrat)

Identification and Assay of Azithromycin Dihydrate equivalent to anhydrous Azithromycin

State FDA, H.Q.Baddi, HP

RDTL

Chandigarh

13

Cefuroxime Axetil Tablets IP (Roxim- 500 Tablets)

457783

Mar-2023

Feb-2026

Reon Pharma, Plot No. F-310, Road No-3, Phase-1st Kathwad, Gidc Bhind Odhav Vepan, Ahmedabad (Gujrat)

Identification, Uniformity of weight and Assay of Cefuroxime Axetil eq. to Cefuroxime

O/o State Drugs Controller, H.Q. Baddi, HP

RDTL

Chandigarh

14

Cefixime Trihydrate and Lactic Acid Bacillus Tablets (MEF-200 LB TABLETS)

MHBT/23/02 5

Apr-2023

Mar-2025

Morisus Healthcare, Ind. Area, Bhagwanpur, Roorkee-247661

Identification and Assay of Cefixime Trihydrate eq. to Anhydrous Cefixime

State FDA H.Q. Baddi, HP

RDTL

Chandigarh

15

Ascorbic Acid +Zinc 500mg/5mg Capsules (MAX-CEE+CAPSULES)

MT-2231

Apr-2023

Mar-2026

Mason Pharma, P1, 125 EPIP, Jharmajri, Dist. Solan (HP), India

Identification and Assay of Zinc Sulphate monohydrate calculated as elemental Zinc and Assay of Sodium Ascorbate calculated as Ascorbic acid

O/o State Drugs Controller, H.Q. Baddi, HP

RDTL

Chandigarh


16

Ascorbic Acid 500 mg Capsules (MAX-CEE CAPSULES)

MT-2232

Apr-2023

Mar-2026

Mason Pharma, P1, 125 EPIP, Jharmajri, Dist. Solan (HP), India

Assay of Sodium Ascorbate calculated as Ascorbic Acid

State FDA H.Q. Baddi, HP

RDTL

Chandigarh

17

TESTO-VAS-250 (Testosterone Mix Compound Injection)

MI-101

Sep-2022

Aug-2025

QP Pharmachem Ltd., F-5, Focal Point, Dera Bassi, SAS Nagar (Pb). 140507.

Particulate Matter and Description

Office of the Assistant Director, Vijayawada, NTR Dist. A.P.

CDL

Kolkata

18

Peritoneal Dialysis Solution IP (1.7% w/v) (PD 1.7 )

1K25276

Nov-2022

Oct-2025

Aculife Healthcare Pvt. Ltd., Sachana, Gujarat 382150, India.

Assay of Calcium

CDSCO

Hyderabad.

CDL

Kolkata

19

SODIUM CHLORIDE INJECTION IP (0.9% w/v) (NS)

S1FBV01

Jan-2022

Dec-2023

Swaroop Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari Industrial Area, Aligarh 202001.

Bacterial endotoxins

CDSCO, Baddi

CDL

Kolkata

20

Heparin Sodium Injection IP 5000 IU/5ml

AGI-23111

May-2023

Apr-2025

Alliance Biotech, 440/3, Vill- Katha, Baddi, Solan (H.P.)-173205

pH, Particulate Matter and Description

O/o. The Drugs Inspector, Odisha, Odisha, Bhubaneswar-V Range, Bhubaneswar

CDL

Kolkata

21

Heparin Sodium Injection IP 5000 IU/5ml

AGI-23110

May-2023

Apr-2025

Alliance Biotech, 440/3, Vill- Katha, Baddi, Solan (H.P.)-173205

pH, Particulate Matter and Description

O/o. The Drugs Inspector, Odisha, Sambalpur Range, Sambalpur

CDL

Kolkata

22

Heparin Sodium Injection IP 5000 IU/5ml

AGI-23109

May-2023

Apr-2025

Alliance Biotech, 440/3, Vill- Katha, Baddi, Solan (H.P.)-173205

Particulate Matter and Description

O/o. The Drugs Inspector, Odisha,

Sambalpur

CDL

Kolkata


Range, Sambalpur

23

Trypsin, Bromelain & Rutoside Trihydrate Tablets (Rednil)

DMT1197B

Aug-2023

Jul-2025

DM Pharma Private Limited (WHO GMP & ISO APPROVED),

NH-21A, Vill. Bhud, Baddi, District Solan, H.P. 173205.

Assay/content of 'Trypsin'

CDSCO, Baddi

CDL

Kolkata

24

Cefepime and Tazobactam for Injection (Pimebest-TZ)

YBZ3101

Jul-2023

Jun-2025

Yeluri Formulations Pvt Ltd., Sy. No. 296/7/6, I.D.A. Bollaram, Sangareddy District- 502325, Telangana, India.

Completeness of solution, Clarity of Solution and Particulate Matter

CDSCO,

Hyderabad

CDL

Kolkata

25

Shercef-TZ (Ceftriaxone and Tazobactam for Injection 1.125 gm)

YSZ3103

Jul-2023

Jun-2025

Yeluri Formulations Pvt Ltd., Sy. No. 296/7/6, I.D.A. Bollaram, Sangareddy District- 502325, Telangana, India.

Completeness of solution, Clarity of Solution and Particulate Matter

CDSCO,

Hyderabad

CDL

Kolkata

26

EDU-AX SYRUP (Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin and Menthol Syrup )

RL22287

Feb-2023

Jan-2025

Rachil Pharma 18-19, Phase-1, Ind. Area, Sansarpur Terrace, District Kangra H.P. 176501

Assay of Ambroxol Hydrochloride, Menthol and Description

O/o CMO,

Bilaspur, HP

CDL

Kolkata

27

Myspas (Mefenamic Acid & Dicyclomine HCl Tablets I.P.)

T-230764

Sep-2023

Aug-2025

Sunlife Sciences, 130, Kurdi, Jhabrera Road, Manglour, Roorkee, Distt. Haridwar (U.K.).

Dissolution

CDSCO, Sub-

Zone, Rishikesh

CDL

Kolkata

28

Fexofenadine Hydrochloride Tablets IP

658-009

Sep-2022

Aug-2024

Signature Phytochemical Industries, 122, MI, Selaqui Industrial Area, Dehradun- 248011.

Dissolution

CDSCO, Zonal Office, Bangalore

CDL

Kolkata

29

Pregabalin SR 75 and Methylcobalamin 1500 mcg Tablets

PMC-2311

Sep-2023

Aug-2025

Seeko biotics, Krishna Nagar- 522502 (A.P.)

Assay of Pregabalin and Methylcobalamin,

Dissolution of

CDSCO ,Sub-

Zone, Visakhapatnam

CDL

Kolkata


Pregabalin and Description

30

Betamethasone Sodium Phosphate Injection IP 4mg/ml

BS-2303

Aug-2023

Jul-2025

Konis Pharmaceuticals Krishna Nagar-522502 (A.P.)

Description , Particulate Matter and Related Substances.

CDSCO ,Sub-

Zone, Visakhapatnam

CDL

Kolkata

31

MULTIVITAMIN TABLETS NFI

TN2212142

Dec-2022

Feb-2024

Adroit Pharmaceuticals Pvt. Ltd., 46, Garoba Maidan, Nagpur- 440008 (M.S)

Assay of vitamin D3 and Description

CDSCO., West

Zone, Mumbai

CDL

Kolkata

32

Levofull (Levofloxacin 500 mg )

23ATE0906

Sep-2023

Aug-2026

Acies Pharmaceutical Pvt. Ltd ., 14, Mile Stone, Rudrapur-Kashipur Road , Gadarpur, Distt. U.S. Nagar, Uttarakhand - 263152, India.

Disintegration and Dissolution

CDSCO, Sub-

Zone, Rishikesh

CDL

Kolkata

33

CEFOPERAZONE INJECTION IP (PICOZONE INJECTION)

HICO23010 A

Oct-2023

Sep-2025

Health Biotech Ltd., Village Sandoli, Nalagarh Road, Baddi, Distt. Solan (H.P.)- 173205.

Particulate matter, Clarity of Solution and Assay

CDSCO, Baddi

CDL

Kolkata

34

LIGNOCAINE HYDROCHLORIDE INJECTION I.P. (A-CAINE)

HILA23013 C

Aug-2023

Jul-2025

Health Biotech Ltd., Village Sandoli, Nalagarh Road, Baddi, Distt. Solan (H.P.)- 173205.

Assay of Lignocaine Hydrochloride

CDSCO, Baddi

CDL

Kolkata

35

Unlabeled white tablets Calcium and Vitamin D3

Unlabeled

Not Mentioned

Not Mentioned

Kanha Biogenetic, Plot No. 1C, E.P.I.P., Phase 1, Jharmajri, Baddi, Dist. Solan, (H.P.)

Assay of Calcium and Description

CDSCO, Baddi

CDL

Kolkata

36

Calcium Carbonate with Vitamin D3 Tablets IP

UP2310036

Oct-2023

Sep-2025

Kanha Biogenetic, Plot No. 1C, E.P.I.P., Phase 1, Jharmajri, Baddi, Dist. Solan, (H.P.)

Assay of Calcium and Description

CDSCO, Baddi

CDL

Kolkata


37

Calcium Carbonate with Vitamin D3 Tablets IP

WB2309007

Sep-2023

Aug-2025

Kanha Biogenetic, Plot No. 1C, E.P.I.P, Phase 1, Jharmajri, Baddi, Dist. Solan, (H.P.)

Assay of Calcium

CDSCO, Baddi

CDL

Kolkata

38

Calcium Carbonate with Vitamin D3 Tablets IP

UP2310033

Oct-2023

Sep-2025

Kanha Biogenetic, Plot No. 1C, E.P.I.P, Phase 1, Jharmajri, Baddi, Dist. Solan, (H.P.).

Assay of Calcium and Description

CDSCO, Baddi

CDL

Kolkata

39

Unlabeled white tablets Calcium and Vitamin D3

Unlabeled

Not Mentioned

Not Mentioned

Kanha Biogenetic, Plot No. 1B, EPIP, Phase 1, Jharmajri, Baddi, Dist. Solan, (H.P.).

Assay of Calcium and Description

CDSCO, Baddi

CDL

Kolkata

40

MOXIZEE-P Eye Drops (Moxifloxacin & Prednisolone Acetate Eye Drops)

1223-319

Aug-2023

Jul-2025

Zee Laboratories Ltd., Behind, 47, Industrial Area, Paonta Sahib- 173025, India.

Assay of Prednisolone

CDSCO ,Sub-

Zone, Visakhapatnam

CDL

Kolkata

41

Heparin Sodium Injection IP 5000 IU/5ml

AGI-23108

May-2023

Apr-2025

Alliance Biotech, 440/3, Village Katha, Baddi, Solan (H.P.)- 173205.

pH, Particulate Matter and Description

State FDA, Odisha, Ganjam-I Range, Berhampur

CDL

Kolkata

42

CALCIUM GLUCONATE INJECTION I.P. 10ml

CG23Y1

May-2023

Apr-2025

Acro Lifesciences (India) Pvt. Ltd., C-86, MIDC, Hingna, Nagpur-16.

Assay of Calcium Gluconate, Particulate Matter and Description.

CDSCO,

Ahmedabad

CDL

Kolkata

43

TESCALVIT D3 Tablets (Calcium Carbonate & Vitamin D3 Tablets)

PT-30296

Feb-2023

Jan-2025

Pharmaroots Health Care, Khasra No.411, Village Tipra, P.O.- Barotiwala, Tehsil Baddi, Distt.

Solan. H.P.

Assay of Vitamin D3 and Description

CDSCO, Zonal Office, Bangalore

CDL

Kolkata

44

Oxytetracycline Injection I.P. 30 ml

TR-129

Oct-2023

Mar-2025

PAR Pharmaceuticals Pvt. Ltd., 5th KM Roorkee Road, Muzaffarnagar (U.P.) - 251003.

Description, pH and Particulate Matter

CDSCO, North Zone, Ghaziabad

CDL

Kolkata


45

STREPTOMYCIN (STREPTOMYCIN INJECTION I.P. (0.75g.) )

STRO-0103

April-2023

Mar-2025

PAR Pharmaceuticals Pvt. Ltd., 5th KM Roorkee Road, Muzaffarnagar (U.P.) - 251001.

Clarity of solution, Particulate Matter and Description

CDSCO, North Zone, Ghaziabad

CDL

Kolkata

46

TELGO-80 (Telmisartan Tablets IP)

OT-231699

Nov-2023

Oct-2025

Orchid Bio-Tech Limited, 65, Peerpura-Delhi Highway, Roorkee- 247667 (U.K.)

Dissolution

CDSCO, Sub-

Zone, Rishikesh

CDL

Kolkata

47

Piroxicam Tablets I.P. 20 mg,

URDT2340

Oct-2023

Sep-2026

Unicure India Ltd., Plot No. 46(B),

/49B, Vill. Raipur, Bhagwanpur, Roorkee, Distt. Haridwar, Uttarakhand.

Dissolution

CDSCO, Sub-

Zone, Rishikesh

CDL

Kolkata

48

HEPARIN SODIUM INJECTION IP 5000 IU/5ML

AGI-23107

May-2023

Apr-2025

Alliance Biotech, 440/3, Vill- Katha, Baddi, Solan (H.P.)-173205

pH, Particulate Matter and Description

O/o. The Drugs Inspector, Odisha, Odisha,Cuttack-V Range,Cuttack.

CDL

Kolkata

49

Heparin Sodium Injection IP 5000 IU/5ml ,(INFA-HEP)

A23LV060B

May-2023

Apr-2025

Infallible Pharma Pvt. Ltd., HO: 202, Matru Smruti Bldg, Lokmanya Tilak Road-2, Behind Swami Narayan Mandir, Dadar (East), Mumbai-400014.

pH, Particulate Matter and Description

O/o. The Drugs Inspector, Odisha, Odisha,Cuttack- VI

Range,Cuttack.

CDL

Kolkata

50

HEPARIN SODIUM INJECTION IP 5000 IU/5ML

AGI-23112

May-2023

Apr-2025

Alliance Biotech , 440/3, Village Katha, Baddi, Solan (H.P.)- 173205.

pH, Particulate Matter, Assay and Description

State FDA, Odisha, Bhubaneswar-III Range, Bhubaneswar.

CDL

Kolkata

51

HEPARIN SODIUM INJECTION IP 5000 IU/5ML

AGI-23113

May-2023

Apr-2025

Alliance Biotech , 440/3, Village Katha, Baddi, Solan (H.P.)- 173205.

pH, Particulate Matter and Description

O/o. The Drugs Inspector, Odisha, Odisha,

Bhubaneswar-III

CDL

Kolkata


Range, Bhubaneswar.

52

HEPARIN SODIUM INJECTION IP 5000 IU/5ML

AGI-23114

May-2023

Apr-2025

Alliaance Biotech, 440/3, Village Katha, Baddi, Solan (H.P.)- 173205.

Particulate Matter and Description

O/o. The Drugs Inspector, Odisha, Odisha, Bhubaneswar-III Range, Bhubaneswar.

CDL

Kolkata

53

MAFNAC-SPAS (MEFENAMIC ACID & PARACETAMOL TABLETS)

MFNT-001

Mar-2022

Feb-2025

Laborate Pharmaceuticals India Ltd., (Unit-II), #31, Rajban Road, Nariwala, Paonta Sahib (H.P.),

Disintegration and Description

State FDA, Drugs Inspector Office, Bokaro-1, Bokaro

CDL

Kolkata

54

Ovit Cee Tablets (Ascorbic Acid Tablets IP )

T-2306-08

Jun-2023

Nov-2024

Oscar Remedies, Johron, Adjoining Industrial Area, Kala- Amb- 173030 (H.P.),

Assay of 'Ascorbic Acid' and Description

CDSCO, Zonal Office, Bangalore

CDL

Kolkata

55

Digiver (Digoxin Injection BP 250 MCG/ML)

E1582204

Dec-2022

Nov-2024

Verve Human Care Laboratories 15-A, Pharmacity, Selaqui Dehradun- 248011 (Uttarakhand), India.

Assay/Content of Digoxin

CDSCO, Sub-

Zone, Rishikesh

CDL

Kolkata

56

Zalcoril-LS Syrup (Ambroxol Hcl, Levosalbutamol & Guaiphenesin Syrup-100 ml)

VDL-1240

Jul-2022

Jun-2024

VVPB Pharmaceuticals Pvt. Ltd., Kh. No. 114, Vill. Damowala, P.O. Barotiwala, Baddi, Dist. Solan (H.P.) -174103

Content of Diethylene Glycol

O/o. District Drugs Control Officer, Prakash Nagar, DCA, A.P.

CDL

Kolkata

57

Itraconazole Capsules 100mg (ITRAKAM 100)

2304104

Apr-2023

Mar-2025

Impulse Pharma Pvt. Ltd., J-201, J. 202/1, MIDC Tarapur, Boisar,

Dist-PaLGHAR-401506,

Maharashtra Sate_ india

Dissolution

CDSCO

West-Zone Mumbai

CDTL-Mumbai

58

Clopidogrel & Aspirin Tablets IP (75mg / 75mg)

MT221335

Apr-2022

Mar-2024

Mascot Health Series Pvt. Ltd., ' Plot No. 79, 80, Sector-6A, IIE,

Sidcul, Haridwar-249403

Related Substances Free Salicylic Acid,

Assay for

CDSCO

West-Zone Mumbai

CDTL-Mumbai


Clopidogrel & Description

59

Diltizem Tablets IP 60mg

GM23005

Mar-2023

Feb-2025

Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Esate, Puhana lqbalpur Road, Roorkee-247667

Related Substances

CDSCO

West-Zone Mumbai

CDTL-Mumbai

60

Metformin Hydrochloride Tablets IP

GT0712

Aug-2023

Jul-2025

Deep Pharma, unit-2, Survey No. 293/3, Behind Jalaram Mandir, Kalikund-Kheda Road, Dholka 382225, Distt. Ahmedabad.

Description

CDSCO

Ahmedabad

CDTL-Mumbai

61

Pantoprazole Tablets I.P.

40mg

PNT/2300 I

May-2023

Apr-2025

Maan Pharmaceuticals Ltd., Plot-I GIDC, Phase-IL Modhera Road, Mehsana-384002, Gujarat

Dissolution (Buffer stage)

CDSCO

West-Zone Mumbai

CDTL-Mumbai

62

Bisacodyl Gastro- Resistance Tablets IP 5mg (Bisacodyl)

EGT10909

Sep-2021

Aug-2024

Elder Labs Limited, Vill : Kishnapur, Baddi-Nalagarh Road, Baddi, Distt. Solan. (H.P.) - 174101

Assay, Dissolution

CDSCO

West-Zone Mumbai

CDTL-Mumbai

63

Cefoperazone Injection IP. (NOZACEF-1 GM)

PD042309

Apr-2023

Mar-2025

Primus Pharmaceuticals, Sadhoura Road, Mouza Ogli Khari Vill Asgarpur Majra, Kala Amb, Distt.

Sirmour-(H. P.) 173030

Assay of Cefoperazone

State Drugs Inspector, Arunachal Pradesh

RDTL,

Guwahati

64

Calcitriol, Calcium Carbonate, Vitamin K2-7, Methylcobalamin, Zinc, Magnesium & L-Methyl Folate Softgel Capsules (Maycal K2 Softgel)

CHD-2039

Feb-2022

Jan-2024

Capsoft Healthcare Pvt. Ltd.,, Shed No. 6, Khasra No. 760- 761, Khalsa Complex, Village Karuna, Sai Road, Baddi, Solan-173205, H.P.

Assay of "Methylcobalamin " & "L-Methyl Folate" and Description.

State Drugs Inspector, Arunachal Pradesh

RDTL,

Guwahati

65

METRONIDAZOLE & FURAZOLIDONE TABLETS (DIARRNIL)

BNT-425

Jun-2022

May-2024

BONN SCHTERING BIO SCIENCES, PLOT NO. 64 & 65, 1ST FLOOR ELECTRONICS

PARK, THIRUBUVANAI,

Disintegration

Inspector of Drugs, Jowai, Meghalaya

RDTL,

Guwahati


MANNADIPET COMMUNE, PUDUCHERRY-605107

66

Glimepiride Tablets IP.. (Glimnol-1 Tablets)

PT-22953

Jan-2023

Dec-2024

Pharmaroots Healthcare, Khasra No. 411, Village Tipra, P.O. Barotiwala, Tehsil Baddi, Distt.

Solan, H.P

Dissolution

State Drugs control Officer, Nagaland

RDTL,

Guwahati

67

Paracetamol & Diclofenac Sodium Tablets (KEZIPYRIN)

KZ-004

Mar-2022

Feb-2024

Indian Remedies, Bhagawat Nagar- 800020

Assay of Paracetamol and Diclofenac Sodium

State Inspector of Drugs, Bihar

RDTL,

Guwahati

68

Itraconazole Capsules BP. (ITROX- 200)

LGL07/150/ 20

Jul-2022

Jun-2024

Logos Pharma, village Maissa Tibba, Tehsil Nalagarh, District Solan (H.P.) - 174101

Dissolution

State Inspector of Drugs, Jharkhand

RDTL,

Guwahati

69

Albendazole Tablets IP (Opida- 400)

23A-T149

Apr-2023

Mar-2025

Orison Pharma International, Khari, Mouza Ogli, Kala Amb,- 173030 (H.P.)

Dissolution

State Drugs Inspector, Arunachal Pradesh

RDTL,

Guwahati

70

Pantoprazole Gastro-resistant Tablets IP (PAN-40)

22442076

Jul-2022

Dec-2024

ALKEM HEALTH SCIENCE,

Unit-2, Samardung, Karek Block, PO- Namthang, South Sikkim- 737137

Assay

State Inspector of Drugs, Bihar

RDTL,

Guwahati

71

Methylergometrine Injection IP (0.2mg/ml)

I-6067

Jan-2023

Dec-2024

Jackson Laboratories Pvt. Ltd., 22- 24, Majitha Road, Bye Pass, Amritsar- 143001

Bacterial endotoxins

State Inspector of Drugs, Madhubani, Bihar

RDTL,

Guwahati

72

AMOXYCILLIN ORAL SUSPENSION I.P. 250 mg/5ml

RD220037

Oct-2022

Sep-2024

RIDLEY LIFE SCIENCE PVT. LTD., D-1651, DSIDC, Indl.

Complex, Narela, Delhi- 110040

Assay & pH

State Inspector of Drugs, Jowai, Meghalaya

RDTL,

Guwahati


73

Glimepiride Tablets I.P. (Glimicut-1)

SG22022

Mar.2022

Feb.2024

Sanctus Global Formulations Limited, Khasra No. 587/588, Village Kunjhal, Backside Jharmjri, Tehsil-Baddi, Distt.- Solan, (H.P.) Pin- 174103

Dissolution

Inspector of Drugs, Jharkhand

RDTL,

Guwahati

74

Paracetamol Tablets IP 500mg. (Galpara)

GPT22003

Jul-2022

Jun-2025

Galpha Laboratories Limited, Village-Thana, Baddi, Himachal Pradesh- 173205

Dissolution

Inspector of Drugs, Meghalaya

RDTL,

Guwahati

75

ISONIAZID TABLETS IP 300 MG (ISONIAZID-300)

PT23-108

May-2023

Apr-2025

Pentachem Pharmaceutical, Chunari Road, Krishnapur, Baddi (H.P.) 173205

Description

Inspector of Drugs, Bihar

RDTL,

Guwahati

76

Paracetamol Tablets IP 650mg. (DAXIPAR-650 Tablets)

DPT22863

Sep-2022

Aug-2024

Daxin Pharmaceuticals Pvt. Ltd. Plot No.121-122 EPIP, Jharmajri Phase 1, Teh. baddi, Distt. Solan (H.P)- 174103.

Dissolution

Inspector of Drugs, Bihar

RDTL,

Guwahati

77

Lycopene, Vitamin A, Vitamine E, Ascorbic Acid, Zinc Sulphate, Copper Sulphate, Manganese Sulphate, Beta Carotene & Sodium Selenate Capsules

RC220065

Nov-2022

Apr-2024

RIDLEY LIFE SCIENCE PVT. LTD., D-1651, DSIDC, Indl.

Complex, Narela, Delhi- 110040

Description

Inspector of Drugs, Meghalaya

RDTL,

Guwahati

78

CALCIUM AND VITAMIN D3 TABLETS I.P.

UDT10673

Feb-2023

Jul-2024

Unicure India Ltd,, C-21, 22 & 23, Sector-3, Noida-201 301, Distt. Gautam Budh Nagar (U.P.).

Description

Inspector of Drugs, Assam

RDTL,

Guwahati

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