CDSCO Drug Alert: 67 Drug Samples Including Sun Pharma Pantocid DSR, Alkem's Pan -D flagged

Published On 2023-02-22 12:17 GMT   |   Update On 2023-12-25 16:17 GMT
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New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 67 medicine batches for failing to qualify for a random drug sample test for the month of January– 2023.

These drug samples include  Rabeprazole Gastro Resistant Tablets IP 20 mg manufactured by Revat Laboratories, Itraconazole Capsules B.P. 100 mg manufactured by Navkar lifesciences, Phenytoin Sodium Tablets IP 100 mg manufactured by Jackson Laboratories, Misoprostol Tablets I.P. 200 mcg manufactured by Ridley Lifescience and others.

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In addition to this, the name of Pantocid DSR (Pantoprazole Gastro-Resistant and Domperidon Prolonged Release Capsules IP) manufactured by Sun Pharma Laboratories is also on the list of samples declared as Not of Standard Quality due to failure of identification and assay of Pantocid DSR. Having said that, the alert also carries a remark noting that on response to the aforementioned alert, pharmaceutical giant Sun Pharma Laboratories has informed the CDSCO office regarding availability of Spurious/ Counterfeit of the said batch of drug.

"Accordingly samples were drawn during the raid. Further Investigation is under process." the CDSCO added to its note.

Furthermore, the list includes Teneligliptin Tablets I.P. 20mg (ZITEN) manufactured by Glenmark Pharmaceuticals, Trypsin Chymotrypsin Tablets (CHYMORAL FORTE TABLETS) manufactured by Torrent pharmaceuticls, Aceclofenac 100 mg & Thiocolchicoside 4 mg Tablets (Zerodol TH 4 Tablets) manufactured by Ipca Laboratories.

Popular marketed drug Pan -D (Pantoprazole Gastro-Resistant and Domperidone Prolonged Release Capsules IP) manufactured by Alkem Health Science, A unit of Alkem Laboratories Limited is also on the list.

The list came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1348 samples. Out of this, 1281 samples were found of standard quality while 67 of them were declared as 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 the disintegration test, failure of pH and identification test, failure of clarity test, failure of specific assay of drug test and others.

The samples collected were tested in six laboratories RDTL Guwahati, CDL Kolkata, CDTL Chennai, CDTL Mumbai, CDTL Hyderabad, RDTL Chandigarh.

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


Total number of samples tested

1348

Total number of samples declared as of Standard Quality

1281

Total number of samples declared as Not of Standard Quality

67

Total number of samples declared as Spurious

-

Total number of samples declared as Misbranded

-


S.No

Name of

Drugs/medical device/cosmetics

Batch No./Date of

Manufacture/Date of Expiry/Manufactured By

Reason for failure

Drawn By

From

1.

Rabeprazole Gastro Resistant Tablets IP 20 mg

B. No.: RRZT-023 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Revat

Laboratories Pvt. Ltd. 12-321, Opp. I.D.A.

Kurnool Road, Pernamitta, Ongole –

523002, Andhra Pradesh.

Assay of Rabeprazole Sodium and Description

Drug Control Department Bihar

RDTL

Guwahati

2.

Rabeprazole Gastro Resistant Tablets IP 20 mg

B. No.: RRZT-021 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Revat

Laboratories Pvt. Ltd. 12-321, Opp. I.D.A.

Kurnool Road,

Pernamitta, Ongole – 523002, Andhra Pradesh.

Assay of Rabeprazole Sodium and Description

Drug Control Department Bihar

RDTL

Guwahati

3.

CIPROFLOXACIN HYDROCHLORID E TABLETS I.P.

500 mg

B. No.: 0701522

Mfg dt: 06/2022 Exp dt: 05/2025

Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No. 14, II Phase, Peenya, Bengaluru – 560

058.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

4.

Lvcipro-500 (Ciprofloxacin Hydrochloride Tablets IP)

B. No.: LV22CT-691 Mfg dt: 03/2022

Exp dt: 02/2024

Mfd by: M/s. L V Life Sciences, VPO Gurumajra, Baddi,

Distt. Solan, Himachal

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati


Pradesh

-174 101.

5.

Ciprofloxacin Tablets IP 500 mg Cipronir 500

B. No.: CCF111004

Mfg dt: 11/2021 Exp dt: 10/2024

Mfd by: M/s. Celebrity Biopharma Ltd.

Village-Panga, Via- Jharmajri, Hill Top Estate, Barotiwala, Distt-solan, Himachal Pradesh-

174103.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

6.

Zinc Sulphate Oral

B. No.: ZS1-21-224

Weight per ml

Drug

RDTL

Solution I.P.,

Mfg dt: 01/2022

Control

Guwahati

100ml

Exp dt: 12/2023

Department

Mfd by: M/s. Ornate Labs

Bihar

Pvt. Ltd. Bela Industrial

Estate, Muzaffarpur-

842005, Bihar.

7.

Zinc Sulphate Oral

B. No.: ZCH-2207

Weight per ml

Drug

RDTL

Solution I.P.,

Mfg dt: 01/2022

Control

Guwahati

100ml

Exp dt: 12/2023

Department

Mfd by: M/s. Apple

Bihar

Formulations Pvt. Ltd.

Plot No. 208 Kishanpur,

Roorkee-247667,

Uttarakhand.

8.

Telmisartan

B. No.: TETY-01

Dissolution

Drug

RDTL

Tablets IP 40 mg

Mfg dt: 04/2021

Control

Guwahati

Exp dt: 03/2023

Department

Mfd by: M/s. NESTOR

Jharkhand

PHARMACEUTICALS

LIMITED. 11, Western

Extension Area,

Faridabad-121 001,

Haryana, INDIA.

9.

Itraconazole

B. No.: CH2006A

Dissolution

Drug

RDTL

Capsules B.P.

Mfg dt: 08/2022

Control

Guwahati

100 mg

Exp dt: 07/2024

Department

Mfd by: M/s. NAVKAR

Assam

LIFESCIENCES, Plot No.

76, Lodhi Majra,

Industrial Area, Baddi,

Distt. Solan, Himachal


Pradesh.

10.

B-complex

B. No.: UGC22020

Description

Drug

RDTL

capsules

Mfg dt: 01/2022

Control

Guwahati

Exp dt: 06/2023

Department

Mfd by: M/s. UNIMARCK

Bihar

HEALTHCARE LTD., Plot

No. 24, 25 & 37, Sector-

6A, SIDCUL, Haridwar-

249 403 Uttarakhand.

11.

ABSORBENT

B. No.: 1786

NEPS

Drug

RDTL

COTTON WOOL

Mfg dt: 05/2021

Control

Guwahati

I.P.

Exp dt: 04/2024

Department

Mfd by: M/s. Om Surgical

Assam

Industries, V & P.O. Titoli,

Jind Road, Rohtak- 124

001, Haryana.

12.

Rabeprazole

B. No.: RRZT-019

Assay

Drug

RDTL

Gastro-Resistant

Mfg dt: 12/2021

and

Control

Guwahati

Tablets IP 20 mg

Exp dt: 11/2023

Description

Department

Mfd by: M/s. Revat

Bihar

Laboratories Pvt. Ltd.,

12-321, Opp. I.D.A,

Kurnool Road,

Pernamitta, Ongole –

523 002, Andhra

Pradesh.

13.

Phenytoin Sodium

B. No.: T-23953

Description

Drug

RDTL

Tablets IP 100 mg

Mfg dt: 02/2021

Control

Guwahati

Exp dt: 01/2023

Department

Mfd by: M/s. Jackson

Meghalaya

Laboratories Pvt. Ltd.,

22-24, Majitha Road, Bye

Pass, Amritsar-143 001,

Punjab (India).

14.

Levocetirizine

B. No.: LZR-2209

pH

Drug

RDTL

Dihydrochloride

Mfg dt: 01/2022

Control

Guwahati

Syrup 30 ml

Exp dt: 12/2023

Department

Mfd by: M/s. Apple

Bihar

Formulations Pvt. Ltd.,

Plot No. 208, Kishanpur,

Roorkee – 247 667,

Uttarakhand.


15.

Levocetirizine Dihydrochloride Syrup 30 ml

B. No.: LZR-2207 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Apple

Formulations Pvt. Ltd., Plot No. 208, Kishanpur, Roorkee – 247 667,

Uttarakhand.

pH

Drug Control Department Bihar

RDTL

Guwahati

16.

Levocetirizine Dihydrochloride Syrup 30 ml

B. No.: LZR-2211 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Apple

Formulations Pvt. Ltd., Plot No. 208, Kishanpur, Roorkee – 247 667,

Uttarakhand.

pH

Drug Control Department Bihar

RDTL

Guwahati

17.

B-Complex Capsules

B. No.: UGC22130 Mfg dt: 06/2022 Exp dt: 11/2023

Mfd by: M/s. UNIMARCK HEALTHCARE LTD.

Plot No. 24, 25 & 37, Sector 6A, SIDCUL, Haridwar-249403,

Uttarakhand.

Description

Drug Control Department Bihar

RDTL

Guwahati

18.

RL-500 ml

Compound Sodium Lactate Injection I.P.

B. No.: S2FBV07 Mfg dt: 01/2022 Exp dt: 12/2023

Mfd by: M/s. SWAROOP Pharmaceuticals Pvt.

Ltd., A-10, Tala Nagari, Industrial Area,

Aligarh – 202 001, Uttar

Pradesh.

Sterility and Bacterial Endotoxins

Drug Control Department Mizoram

RDTL

Guwahati

19.

B-Complex Capsules

B. No.: UGC22131 Mfg dt: 06/2022 Exp dt: 11/2023

Mfd by: M/s. UNIMARCK HEALTHCARE LTD.

Plot No. 24, 25 & 37, Sector 6A, SIDCUL, Haridwar-249403 Uttarakhand.

Description

Drug Control Department Bihar

RDTL

Guwahati


20.

Erythromycin Stearate Tablets IP 250 mg

(Erycon™-250)

B. No.: VGT11028 Mfg dt: 10/2021 Exp dt: 09/2024 Mfd by: M/s. Vobb Healthcare, Vill. Kishanpura, Baddi- Nalagarh Road, Baddi, Distt. Solan, Himachal Pradesh -

174 101.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

21.

.

Amoxycillin 250 mg and Cloxacillin 250 mg Capsules

B. No.: 21BC012

Mfg dt: 05/2021 Exp dt: 04/2023

Mfd by: M/s. Maxmed Lifesciences Pvt. Ltd. Plot No-54, Sector-IIDC, SIDCUL, Rudrapur,

Uttarakhand.

Description

Drug Control Department Meghalaya

RDTL

Guwahati

22.

Zinc Sulphate Oral Solution I.P.,

100 ml

B. No.: ZCH-2209 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Apple

Formulations Pvt. Ltd., Plot No. 208, Kishanpur, Roorkee – 247 667,

Uttarakhand.

Weight per ml

Drug Control Department Bihar

RDTL

Guwahati

23.

KOOCAL-500

Tablets (Calcium with

Vitamin D Tablets IP)

B. No.: TG21-2330

Mfg dt: 09/2021 Exp dt: 02/2023

Mfd by: M/s. Athens Life Sciences Mauza Rampur Jattan, Nahan Road, Kala Amb, Distt. Sirmour, Himachal Pradesh .-

173030.

Assay of Vitamin D3

Drug Control Department Mizoram

RDTL

Guwahati

24.

KOOCAL-500

(Calcium with Vitamin D Tablets IP)

B. No.: TG21-2550

Mfg dt: 10/2021 Exp dt: 03/2023

Mfd by: M/s. Athens Life Sciences , Mauza Rampur Jattan, Nahan Road, Kala Amb, Distt. Sirmour, Himachal

Pradesh -173030.

Assay of Vitamin D3

Drug Control Department Mizoram

RDTL

Guwahati


(A WHO - GMP

CERTIFIED Company).

25.

Zinc Sulphate

B. No.: LMT210773

Disintegration

Drug

RDTL

Tablets 50 mg

Mfg dt: 08/2021

Control

Guwahati

Zincload-50

Exp dt: 07/2023

Department

Mfd by: M/s. Life Max

Mizoram

Cancer Laboratories

Plot No. 106 & 106 A,

Sector-6A, IIE,

SIDCUL, Haridwar-

249 403, Uttarakhand.

26.

Neurace (Vitamin

B. No.: C00458

Assay of

CDSCO

CDL

A, C, E &

Mfg dt: 07/2022

Vitamin A

East Zone

Kolkata

Selenium

Exp dt: 12/2023

Kolkata

Capsules )

Mfd by: M/s. East West

Pharma (India) Pvt. Ltd.,

Kh No. 196, Raipur

Industrial Area,

Bhagwanpur, Roorkee,

Dist. Haridwar,

Uttarakhand – 247 661,

India.

27.

Hycorlin 100 mg

B. No.: DD2I002

Clarity of Solution

CDSCO

CDL

(Hydrocortisone

Mfg dt: 09/2022

East Zone

Kolkata

Sodium Succinate

Exp dt: 08/2024

Kolkata

Injection IP)

Mfd by: M/s. Scott - Edil

Pharmecia Ltd., 56,

E.P.I.P. Phase I,

Jharmajri, Baddi Distt.

Solan – 173 205 (H.P.),

India.

28.

ORLICA (Orlistat

B. No.: G22OEB001

Dissolution

CDSCO

CDL

Capsules U.S.P.

Mfg dt: 06/2022

East Zone

Kolkata

120 mg)

Exp dt: 05/2024

Kolkata

Mfd by: M/s. Acme

Generics Private Limited,

Plot No. 115, HPSIDC,

Industrial Area, Vill.

Davni, P.O. Gurumajra,

Tehsil Nalagarh, Distt.

Solan, Himachal

Pradesh, 174101, India.


29.

Misoprostol Tablets I.P. 200 mcg

B. No.: RT220304

Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Ridley

Lifescience Pvt. Ltd., D- 1651, DSIDC, Indl.

Complex, Narela,

Delhi - 110 040.

Assay

CDSCO

East Zone Kolkata

CDL

Kolkata

30.

SECROX

(Cefuroxime Injection I.P. 1.5 gm), Sterile water for Injection I.P.

20 ml

B. No.: AB301008C

Mfg dt: 05/2021 Exp dt: 04/2023

Mfd by: M/s. Bengene Life Sciences Pvt. Ltd. Village Kishanpura, P.O. Manpura, Baddi - Nalagarh Road, Tehsil - Nalagarh, Distt. Solan,

H.P. 174 101 (India).

For WFI:

B. No.: WM21E005,

Mfg dt: 05/2021, Exp dt: 04/2024,

Mfd by: M/s. Hindustan Polyfab, Plot No. 12, Ind Area, Davni Baddi, Himachal Pradesh – 173

205.

Particulate Matter

CDSCO

South Zone Chennai

CDL

Kolkata

31.

SECROX

(Cefuroxime Injection I.P. 1.5 gm), Sterile water for Injection I.P.

20 ml

B. No.: FAB302008

Mfg dt: 04/2022 Exp dt: 03/2024

Mfd by: M/s. Bengene Life Sciences Pvt. Ltd. Village Kishanpura, P.O. Manpura, Baddi - Nalagarh Road, Tehsil - Nalagarh, Distt. Solan, Himachal Pradesh - 174 101 (India).

For WFI:

B. No.: FW20-09,

Mfg dt: 02/2022, Exp dt: 01/2027, Mfd by: M/s. Bhanu

Healthcare Pvt. Ltd.,

Particulate Matter

CDSCO

South Zone Chennai

CDL

Kolkata


V.P.O. Gurumajra, Nalagarh, Baddi, Solan, Himachal Pradesh – 173

205.

32.

Romavit Capsules

B. No.: K21CS-63

Description, Assay

CDSCO

CDL

(Amino Acids,

Mfg dt: 09/2021

of Folic Acid, N-

South Zone

Kolkata

Biotin, Folic Acid,

Exp dt: 02/2023

Acetyl Cysteine,

Chennai

Vitamins and

Mfd by: M/s. Kaizen

Ascorbic Acid

Minerals

Research Labs India Pvt.

Capsules)

Ltd., No. 705/5B, Old

Thiruthani Salai,

Melpudupettai,

Ananthalai Panchayat,

Walajapet T.K. Vellore,

District -632513,

Tamilnadu.

33.

Romavit Capsules

B. No.: K22CS-36

Description, Assay

CDSCO

CDL

(Amino Acids,

Mfg dt: 05/2022

of N-Acetyl Cysteine

South Zone

Kolkata

Biotin, Folic Acid,

Exp dt: 10/2023

Chennai

Vitamins and

Mfd by: M/s. Kaizen

Minerals

Research Labs India Pvt.

Capsules)

Ltd., No. 705/5B, Old

Thiruthani Salai,

Melpudupettai,

Ananthalai - Panchayat,

Walajapet T.K. Vellore,

District – 632 513,

Tamilnadu.

34.

Cuprox-10

B. No.: G-153/4014

Dissolution

CDSCO

CDL

(Isoxsuprine

Mfg dt: 09/2021

West Zone

Kolkata

Hydrochloride

Exp dt: 08/2023

Mumbai

Tablets I.P. 10 mg)

Mfd by: M/s. Elfin Drugs

Pvt. Ltd., Vill. Berson,

Nalagarh, Himachal

Pradesh - 174 101.

35.

Montelukast

B. No.: TE2027A

Description

CDSCO

CDL

Sodium and

Mfg dt: 05/2022

West Zone

Kolkata

Levocetirizine

Exp dt: 04/2024

Mumbai

Hydrochloride

Mfd by: M/s. Navkar

Tablets IP

Lifesciences, Plot No. 76,

Lodhi Majra, Industrial

Area, Baddi, Distt. Solan,

Himachal Pradesh.


36.

Atorvastatin & Aspirin Capsules (10 / 75)

B. No.: AAC1010 Mfg dt: 11/2021 Exp dt: 10/2023

Mfd by: M/s. Vivimed Labs Limited, D-125 & 128, Phase III, I.D.A,

Jeedimetla, Medchal - Malkajgiri District, Telangana State –

500 055.

Dissolution of Atorvastatin

CDSCO

Sub-Zone Guwahati

CDL

Kolkata

37.

Budecort Respules

0.5 mg (Budesonide

Nebuliser Suspension B.P.)

B. No.: IA20131

Mfg dt: 02/2022 Exp dt: 01/2024

Mfd by: M/s. Cipla Ltd., Plot 9 & 10, Indore SEZ Pithampur, Madhya

Pradesh - 454 775, India

Assay

CDSCO

Ahmedabad

CDL

Kolkata

38.

Montellion-10 (Montelukast Tablets IP 10 mg)

B. No.: T3092

Mfg dt: 10/2022 Exp dt: 09/2024

Mfd by: M/s. Stallion Laboratories Pvt. Ltd., C- 1B, 305/2, 3 4 & 5,

G.I.D.C. Kerala (Bavla),

Distt. Ahmeadbad - 382220, Gujarat.

Assay

CDSCO

Ahmedabad

CDL

Kolkata

39.

Pan -D (Pantoprazole Gastro-Resistant and Domperidone Prolonged Release Capsules IP)

B. No.: 22442611

Mfg dt: 09/2022 Exp dt: 08/2024 Mfd by: M/s. Alkem

Health Science, A unit of Alkem Laboratories Limited, Unit -2, Samardung, Karek Block,

P.O. Namthang, South

Sikkim – 737 137.

Identification and Assay

CDSCO

East Zone Kolkata

CDL

Kolkata

40.

Pantocid DSR (Pantoprazole Gastro-Resistant and Domperidon Prolonged Release Capsules IP)

B. No.: SID0427A Mfg dt: 02/2022 Exp dt: 01/2024

Mfd by: M/s. Sun Pharma Laboratories Ltd., Plot No. 107-108, Namli Block, P.O. Ranipool, East Sikkim 737 135.

Identification and Assay

CDSCO

East Zone Kolkata

CDL

Kolkata

*Remark:

The firm M/s. Sun Pharma, notified this office regarding availability of Spurious/ Counterfeit of

the said batch of drug.


Accordingly samples were drawn during the raid. Further

Investigation is under process.

41.

Metronidazole Tablets IP 400 mg

B. No.: 3000521

Mfg dt: 03/2021 Exp dt: 02/2024

Mfd by: M/s. Karnataka Antibiotics and Pharmaceuticals Ltd., Plot No.14, II Phase, Peenya Industrial Area,

Bengaluru-560058.

Dissolution

CDSCO

Subzone Bangalore

CDTL

Chennai

42.

Apvaas 20 (Atorvastatin Calcium Tablets USP 20 mg)

B. No.: RE641 Mfg dt: 08/2022 Exp dt: 07/2025 Mfd by: M/s. Rivon

Pharmaceuticals LLP, Plot No.33, Kamla Amrut Industrial Park, Indrad, Tal. Kadi, District :

Mehsana, Gujarat.

Uniformity of weight

CDSCO

Zonal Office Ahmedabad

CDTL

Mumbai

43.

Neorelax Gel (Diclofenac Gel I.P.)

B. No.: Q2203

Mfg dt: 06/2022 Exp dt: 05/2024

Mfd by: M/s. Curetech Skincare, Plot No. 33 & 34, Phase-IV, Bhatoli Kalan, Baddi, Dist. Solan, Himachal Pradesh - 173

205.

Related substances

CDSCO

West-Zone Mumbai

CDTL

Mumbai

44.

Hydroxyzine HCl IP /BP

B. No.: 225004010

Mfg dt: 08/2022 Exp dt: 07/2027 Mfd by: M/s. Srikem

Laboratories Pvt. Ltd., Plot 17/24, 17/23, 17/22,

17/13, MIDC Taloja- 410208, Taluka Panvel, Dist. Raigad,

Maharashtra.

Appearance of solution

CDSCO

West - Zone Mumbai

CDTL

Mumbai

45.

Hydroxyzine HCl IP /BP

B. No.: 225004015

Mfg dt: 09/2022 Exp dt: 08/2027

Appearance of solution

CDSCO

West - Zone Mumbai

CDTL

Mumbai


Mfd by: M/s. Srikem Laboratories Pvt. Ltd., Plot 17/24, 17/23, 17/22,

17/13, MIDC Taloja- 410208, Taluka Panvel, Dist. Raigad.,

Maharashtra.

46.

Hydroxyzine HCl IP /BP

B. No.: 225004009

Mfg dt: 08/2022 Exp dt: 07/2027 Mfd by: M/s. Srikem

Laboratories Pvt. Ltd., Plot 17/24, 17/23, 17/22,

17/13, MIDC Taloja- 410208, Taluka Panvel, Dist. Raigad.

Maharashtra.

Appearance of solution

CDSCO

West - Zone Mumbai

CDTL

Mumbai

47.

Hydroxyzine HCl IP /BP

B. No.: 225004011

Mfg dt: 08/2022 Exp dt: 07/2027 Mfd by: M/s. Srikem

Laboratories Pvt. Ltd., Plot 17/24, 17/23, 17/22,

17/13, MIDC Taloja- 410208, Taluka Panvel, Dist. Raigad.

Maharashtra.

Appearance of solution

CDSCO

West - Zone Mumbai

CDTL

Mumbai

48.

Hydroxyzine HCl IP /BP

B. No.: 225004007

Mfg dt: 07/2022 Exp dt: 06/2027 Mfd by: M/s. Srikem

Laboratories Pvt. Ltd., Plot 17/24, 17/23, 17/22,

17/13, MIDC Taloja- 410208, Taluka Panvel, Dist. Raigad.

Maharashtra.

Appearance of solution

CDSCO

West - Zone Mumbai

CDTL

Mumbai

49.

Chymnetra-Forte (Trypsin- Chymotrypsin Tablets)

B. No.: TTP-22017

Mfg dt: 02/2022 Exp dt: 01/2025

Mfd by: M/s. D.R. Johns Lab Pvt. Ltd – Plot No.3, Sector 6A, IIE, SIDCUL,

Haridwar- 249403,

Disintegration time and Assay

CDSCO

West - Zone Mumbai

CDTL

Mumbai


Uttarakhand.

50.

INDIFIBER

(Fenofibrate Capsules I.P.)

B. No.: 6078

Mfg dt: 04/2022 Exp dt: 03/2024

Mfd by: M/s. INDILINA PHARMACEUTICALS,

Hambran Road, Jainpur, Ludhiana- 142027,

Punjab.

Dissolution

CDSCO

West - Zone Mumbai

CDTL

Mumbai

51.

Teneligliptin Tablets I.P. 20mg (ZITEN)

B. No.: 18220490

Mfg dt: 07/2022 Exp dt: 06.2024

Mfd by: M/s. Glenmark Pharmaceuticals Ltd.,Samlik Marchak, Industrial Growth Centre, East Sikkim, Sikkim-

737135

Dissolution

CDSCO

Zonal Office Hyderabad

CDTL

Hyderabad

52.

Adhesive Tape USP (Micropore Surgical Tape)

B. No.: R03200508

Mfg dt: 03/2020 Exp dt: 02/2025

Mfd by: M/s. 3M India Limited, B-20, MIDC – Ranjangaon, Tal. Shirur, Pune, Maharashtra-

412 220.

Tensile strength per

2.54 cm of width

Drug Control Department Gujarat

RDTL

Chandigarh

53.

Alpha Lipoic Acid, Folic Acid, Mecobalamin Pyridoxine, Viatmin D3 Tablet (NILCOBAL-D TABLETS)

B. No.: RP1T63 Mfg dt: 06/2022 Exp dt: 05/2023

Mfd by: M/s. Relieve Pharmaceuticals, Khasra No. 2032/2, Vill.

Chandpur The. Haroli,

Una, Himachal Pradesh.

Identification and

Assay of Alpha Lipoic Acid, Folic Acid, Mecobalamin, Vitamin D3 and the Assay of Pyridoxine

Hydrochloride

Drug Control Department Delhi

RDTL

Chandigarh

54.

Trypsin- Chymotrypsin Tablets (CHYMORAL FORTE TABLETS)

B. No.: 2JH3H019 Mfg dt: 04/2021 Exp dt: 03/2023

Mfd by: M/s. TORRENT PHARMACEUTICLS

LTD., 32 No. Middle Camp, NH-10, East District, Gangtok, Sikkim- 737 135.

Disintegration test (Acid Medium)

Drug Control Department Delhi

RDTL

Chandigarh


55.

Cloxacillin Sodium Capsules IP

500 mg

B. No.: RC220021

Mfg dt: 02/2022 Exp dt: 01/2024

Mfd by: M/s. Ridley Life Science Pvt Ltd., D-1651, DSIDC Indl Complex,

Narela, Delhi - 110040.

Assay of Cloxacillin Sodium calculated as Cloxacillin

Drug Control Department Delhi

RDTL

Chandigarh

56.

Prednisolone Tablets IP 5 mg

B. No.: DTB-130 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. DAFFODILLS

PHARMACEUTICALS

LTD., Jawahar Nagar, Rohta Road, Meerut - 250 001, Uttar Pradesh

(INDIA).

Related Substances

CDSCO

North Zone Ghaziabad

RDTL

Chandigarh

57.

Voglibose Tablets IP (0.2 mg)

B. No.: TV-880012

Mfg dt: 02/2022 Exp dt: 01/2024

Mfd by: M/s. Centurion Remedies Pvt. Ltd., G/5 and G/6 industrial Estate Gorwa, Vadodara-

390016, Gujarat.

Disintegration

CDSCO

North Zone Ghaziabad

RDTL

Chandigarh

58.

Peritoneal Dialysis Solution IP with 1.5% w/v Dextrose

B. No.: PD2206101

Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Mitra

Industries (P) Ltd., 14/4, Delhi-Mathura Road, Faridabad-121 003,

Haryana, India.

Assay of Calcium Magnesium and Lactate

CDSCO

North Zone Ghaziabad

RDTL

Chandigarh

59.

Frusemide Tablets IP 40 mg

B. No.: FXTZ-08 Mfg dt: 08/2022 Exp dt: 07/2024 Mfd by: M/s. Nestor

Pharmaceuticals, Limited, 11, Western, Extension

Area, Faridabad- 121

001, Haryana, India.

Uniformity of weight and Dissolution test

CDSCO

North Zone Ghaziabad

RDTL

Chandigarh


60.

Peritoneal Dialysis Solution IP with 2.5% w/v Dextrose

B. No.: PD2206098

Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Mitra

Industries (P) Ltd., 14/4, Delhi-Mathura Road, Faridabad-121 003, Haryana, India.

Assay of Calcium, Magnesium and Lactate

CDSCO

North Zone Ghaziabad

RDTL

Chandigarh

61.

Aceclofenac 100 mg & Thiocolchicoside 4 mg Tablets (Zerodol TH

4 Tablets)

B. No.: FXT011022AS Mfg dt: 12/2021

Exp dt: 11/2024 Mfd by: M/s. Ipca Laboratories Ltd.,

393/394, Melli Jorethang Road, Gom Block, Bharikhola, South

District, Sikkim-737 121.

Identification and Assay of Thiocolchicoside

Drug Control Department Himarchal Pradesh

RDTL

Chandigarh

62.

Aceclofenac 100 mg & Thiocolchicoside 4 mg Tablets (Zerodol TH

4 Tablets)

B. No.: FXT012008AS Mfg dt: 03/2022

Exp dt: 02/2025 Mfd by: M/s. Ipca Laboratories Ltd.,

393/394, Melli Jorethang Road, Gom Block, Bharikhola, South District,

Sikkim-737 121.

Identification and Assay of Thiocolchicoside

Drug Control Department Himarchal Pradesh

RDTL

Chandigarh

63.

Loose yellow colored Tablets (Purported to contain Rosuvastatin 10 mg)

B. No.: Not Mentioned Mfg dt: null

Exp dt: null

Mfd by: Manufactured in the premises of firm

M/s Trizal Formulation, Plot No. 29, HPSIDC,

Industrial Area, Distt. Solan, Himachal

Pradesh.

Assay of Rosuvastatin

Drug Control Department Himarchal Pradesh

RDTL

Chandigarh

64.

Loose Powder (Purported to be contain Telmisartan)

B. No.: Not Mentioned Mfg dt: null

Exp dt: null

Mfd by: Not Mentioned, NM.

Identification of Telmisartan

Drug Control Department Himarchal Pradesh

RDTL

Chandigarh


65.

Aceclofenac and Thiocolchicoside Tablets (Acetan- TH Tablets)

B. No.: RT-190622

Mfg dt: 06/2022 Exp dt: 05/2024

Mfd by: M/s. Renowed Life Sciences, HACCP & ISO 9001:2015

Certified Co. Plot No.12, Sector-6B, SIDCUL,

Haridwar-249403,

Uttarakhand (INDIA).

Assay of Aceclofenac

Drug Control Department Himarchal Pradesh

RDTL

Chandigarh

66.

Levocetirizine Hydrochloride Tablets IP (Levocetirizine Tablets)

B. No.: AF-22T619

Mfg dt: 08/2022 Exp dt: 07/2024 Mfd by: M/s. Affine Formulations Ltd.,

1947/3, Vill. Bhatian, Tehsil Nalagarh, Distt. Solan 174101, Himachal

Pradesh, India.

Dissolution

CDSCO

North Zone Ghaziabad

RDTL

Chandigarh

67.

Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (GlimiSave M2 Tablets)

B. No.: GGLV22007 Mfg dt: 03/2022 Exp dt: 02/2025 Mfd by: M/s. Eris

Lifesciences Limited, Amingaon, North Guwahati, Dist. Kamrup -

(Assam) 781031.

Dissolution

Drug Control Department Himachal Pradesh

RDTL

Chandigarh


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