59 Drug Samples Including Cadila pharma Aciloc 150 Fail To Qualify CDSCO Test

Published On 2022-10-18 12:30 GMT   |   Update On 2023-10-17 10:56 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 59 medicine batches for failing to qualify a random drug sample test for the month of September, 2022.

This came in line with the list of drugs, medical devices and cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of September, 2022.

These drug samples which are declared not of standard quality include Paracetamol Tablets IP 650 mg, Ascorbic Acid Tablets IP 500 mg manufactured by ANG Lifesciences India, Montelukast Sodium and Levocetirizine Dihydrochloride Tablets IP (Viznil) manufactured by Tirupati Medicare Limited, Atorvastatin Tablets IP 20 mg manufactured by Galpha Laboratories, Azithromycin Tablets IP 500mg AZUSTAN-500 Tablets manufactured by Mediwell Biotech and others.

Furthermore, other popular drug samples that are declared not of standard quality include Pure & Cure Healthcare's Clopidogrel and Aspirin Tablets I.P, Divalproex Sodium Tablets IP 500 mg, Zee Laboratory's Vildazem M 1000 (Vildagliptin 50 mg & Metformin Hydrochloride 1000 mg Tablets I.P.), and etc.

Apart from this, few batches of Ranitidine Tablets IP 150 mg (ACILOC 150) manufactured by Cadila Pharmaceuticals and few batches of Rosuvastatin Calcium Tablets IP 10 mg manufactured by Synokem Pharmaceuticals are on the list.

This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1456 samples. Out of these, 1397 samples were found to be of standard quality while 59 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 sterility test, failure of pH, failure of identification and Assay of Vitamin D3 and etc.

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

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of September – 2022.

Total number of samples tested

1456

Total number of samples declared as of Standard Quality

1397

Total number of samples declared as Not of Standard Quality

59

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.

Pantoprazole Sodium Gastro Resistant Tablets I.P. Pantofer-40 Tablets

B. No.: T 21351

Mfg dt: 12/2021 Exp dt: 11/2023

Mfd by: M/s. Wamika Pharmaceuticals Pvt. Ltd., #318, H.S.I.I.D.C.

Industrial Growth Centre, Saha-133104,

Haryana (INDIA).

Dissolution (Buffer Stage)

Drug Control Department Jharkhand

RDTL

Guwahati

2.

Ocean®-OZ (Ofloxacin & Ornidazole Tablets)

B. No.: SMT-922 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. SMBJ

PHARMACEUTICALS

PVT. LTD. (An ISO

9001:2015 Certified Co.) Plot No-330, Phase-1, HSIIDC,

Industrial Estate,

Barhi-131101 Haryana.

Dissolution

Drug Control Department Bihar

RDTL

Guwahati

3.

Ornigyl-O (Ofloxacin and Ornidazole Tablets I.P.)

B. No.: B22122001

Mfg dt: 01/2022 Exp dt: 12/2023

Mfd by: M/s. TORQUE PHARMACEUTICALS PVT. LTD. 13B-14,

EPIP-I, Jharmajri Himachal Pradesh -

173205.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

4.

PARACETAMOL TABLETS IP

(Larkin)

B. No.: E-23

Mfg dt: 12/2021 Exp dt: 11/2024

Dissolution

Drug Control

Department Mizoram

RDTL

Guwahati


Mfd by: M/s Lark Laboratories (India) Ltd., Works at: SP - 1192 E, Phase-IV,

RIICO Industrial Area, Bhiwadi-301019, Dist. Alwar, Rajasthan.

5.

NTP-650

(Paracetamol

B. No.: 21F-16

Mfg dt: 06/2021

Dissolution

Drug Control

Department

RDTL

Guwahati

Tablets I.P. 650

Exp dt: 05/2023

Jharkhand

mg.)

Mfd by: M/s.

KRYPTON

PHARMACEUTICALS,

69B, Export Promotion

Industrial Park, Phase-

I, Jharmajri, Baddi,

Dist. Solan-173205,

Himachal Pradesh.

6.

Paracetamol

B. No.: T120210

Dissolution

Drug Control

RDTL

Tablets IP 650 mg

Mfg dt: 02/2022

Department

Guwahati

Exp dt: 01/2024

Assam

Mfd by: M/s. ANG

Lifesciences India Ltd.,

Village Malkumajra,

Nalagarh Road, Baddi,

Dist. Solan - 173205

Himachal Pradesh.

7.

Dried Ferrous

B. No.: TE22-24

Description

Drug Control

RDTL

Sulphate & Folic

Mfg dt: 05/2022

Department

Guwahati

Acid Tablets IP

Exp dt: 04/2024

Assam

Mfd by: M/s. OM

BIOMEDIC PVT. LTD.,

Plot No.68,69, 82 & 83

Sector-6A, IIE ,

SIDCUL, Haridwar-

249403, Uttarakhand,

India.

8.

Montelukast Sodium

B. No.: VNE2101

Description

Drug Control

RDTL

and Levocetirizine

Mfg dt: 06/2021

Department

Guwahati

Dihydrochloride

Exp dt: 05/2023

Jharkhand

Tablets IP (Viznil)

Mfd by: M/s. Tirupati

Medicare Limited.

Nahan Road, Paonta

Sahib, Dist. Sirmour,

Himachal Pradesh -


173025.

9.

ALCIFLOX® 500

(Ciprofloxacin Tablets IP)

B. No.: ACT21015SL Mfg dt: 10/2021

Exp dt: 09/2024 Mfd by: M/s. Shiva Biogenetic

Laboratories Pvt. Ltd.

Village Manpura, Baddi, Dist. Solan, Himachal Pradesh -

174101.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

10.

Rabeprazole Gastro Resistant Tablets

I.P. 20 mg

B. No.: RRZT-020 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

Drug Control Department Bihar

RDTL

Guwahati

11.

Ascorbic Acid Tablets IP 500 mg

B. No.: T392006

Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. ANG

Lifesciences India Ltd. Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan- 173205

Himachal Pradesh.

Description

Drug Control Department Assam

RDTL

Guwahati

12.

WARCETIZ

(Cetirizine

B. No.: MT-21465

Mfg dt: 12/2021

Description

Drug Control

Department

RDTL

Guwahati

Hydrochloride

Exp dt: 11/2023

Jharkhand

Tablets IP)

Mfd by: M/s. Medimark

Drugs &

Pharmaceuticals Plot

no. 39, Sector 6A, IIE,

SIDCUL, Haridwar-

249403, Uttarakhand.

13.

KOOCAL-500

B. No.: TG21-2549

Identification and

Drug Control

RDTL

(Calcium with

Mfg dt: 10/2021

Assay of Vitamin

Department

Guwahati

Vitamin D Tablets

Exp dt: 03/2023

D3

Mizoram

IP)

Mfd by: M/s. Athens

Life Sciences, Mauza


Rampur Jattan, Nahan Road, Kala Amb, Distt. Sirmour, Himachal

Pradesh – 173030.

14.

Glimepiride Tablets IP 1 mg.

Glimvale-1 Tablets

B. No.: 21JP/T-2247

Mfg dt: 12/2021 Exp dt: 11/2023

Dissolution

Drug Control Department

Jharkhand

RDTL

Guwahati

Mfd by: M/s. Jips

Pharmaceuticals Pvt.

Ltd. Plot No. E-13,

Phase 7, Industrial

Area, SAS Nagar,

Punjab, India 160055.

15.

Levocetirizine

B. No.: LZR-2202

pH

Drug Control

RDTL

Dihydrochloride

Mfg dt: 01/2022

Department

Guwahati

Syrup

Exp dt: 12/2023

Bihar

Mfd by: M/s. Apple

Formulations Pvt. Ltd.

Plot No. 208,

Kishanpur, Roorkee-

247667, Uttarakhand.

16.

OMECAP

(Omeprazole

B. No.: LPOC-035

Mfg dt: 07/2021

Dissolution

Drug Control

Department

RDTL

Guwahati

Capsules IP 20 mg)

Exp dt: 06/2023

Assam

Mfd by: M/s. Laborate

Pharmaceuticals India

Ltd. (Unit-II),#31,

Rajban Road,

Nariwala, Paonta

Sahib, Himachal

Pradesh.

17.

Ranitidine Tablets IP 150 mg

(ACILOC 150)

B. No.: LD22114

Mfg dt: 02/2022 Exp dt: 07/2024

Description

Drug Control

Department Jharkhand

RDTL

Guwahati

Mfd by: M/s. CADILA

PHARMACEUTICALS

LIMITED, 1389,

Dholka- 382225, Dist.:

Ahmedabad, Gujarat.

18.

IM-OKTM

(Levocetirizine

B. No.: T-5479

Mfg dt: 09/2021

Dissolution

Drug Control

Department

RDTL

Guwahati

Hydrochloride

Exp dt: 08/2023

Jharkhand

Tablets IP)

Mfd by: M/s. Sarwal

Laboratory Plot No. 50, Industrial Area,


Phase-1 Gwalthai

Distt. Bilaspur, Himachal Pradesh.

19.

Co-trimoxazole Tablets IP SS

B. No.: CM-121 Mfg dt: 07/2021 Exp dt: 06/2023

Mfd by: M/s. High Tech Pharma, 49, Khandelwal Compound, Plada, Indore, Madhya Pradesh.

Disintegration

Drug Control Department Nagaland

RDTL

Guwahati

20.

Rosuvastatin Calcium Tablets IP 10 mg

B. No.: 21S1GTA035 Mfg dt: 01/2021

Exp dt: 12/2022 Mfd by: M/s.

SYNOKEM PHARMACEUTICALS LTD. Plot No.: 35-36,

Sector-6A, I.I.E (SIDCUL), Ranipur (BHEL), Haridwar-

249403, Uttarakhand.

Dissolution

Drug Control Department Uttar Pradesh

RDTL

Guwahati

21.

Sin-DSR

(Rabeprazole

B. No.: UCA-21063

Mfg dt: 08/2021

Assay for

Rabeprazole

Drug Control

Department

RDTL

Guwahati

Sodium (EC) &

Exp dt: 07/2023

Sodium

Uttar Pradesh

Domperidone

Mfd by: M/s. UPKAR

Sustained Release

PHARMACEUTICALS

Capsules)

101, Industrial area,

Gondpur, Paonta

Sahib, Distt. Sirmour

Himachal Pradesh –

173025.

22.

Atorvastatin Tablets

B. No.: AVAT21006

Dissolution

Drug Control

RDTL

IP 20 mg

Mfg dt: 05/2021

Department

Guwahati

Exp dt: 04/2023

Assam

Mfd by: M/s. Galpha

Laboratories Limited

Village- Thana, Baddi,

Himachal Pradesh –

173205.

23.

LEVOTHYROXINE SODIUM TABLETS

IP 50 mcg

B. No.: TL-740003

Mfg dt: 01/2022 Exp dt: 12/2023

Mfd by: M/s. Centurion

Assay

Drug Control Department Assam

RDTL

Guwahati


Remedies Pvt. Ltd. G/5 & G/6, Industrial Estate, Gorwa, Vadodara- 390016,

Gujarat.

24.

Lvcipro 500 - tablets (Ciprofloxacin Hydrochloride Tablets IP)

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

Exp dt: 02/2024 Mfd by: M/s. LV Life Sciences VPO Gurumajra, Baddi,

Dist.- Solan, Himachal

Pradesh – 174101.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

25.

Zinc Sulphate Dispersible Tablets IP 20 mg

B. No.: MOT22139 Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. MEDICAMEN

Organics Limited Plot No. 61, Sector-6A, IIE, SIDCUL, Haridwar-

249403, Uttarakhand.

Uniformity of Dispersion and Disintegration

CDSCO

Sub-Zone Guwahati

RDTL

Guwahati

26.

LEVOTHYROXINE SODIUM TABLETS

IP 50 mcg

B. No.: TL-740003

Mfg dt: 01/2022 Exp dt: 12/2023

Mfd by: M/s. Centurion Remedies Pvt. Ltd.

G/5 & G/6, Industrial Estate, Gorwa, Vadodara- 390016,

Gujarat.

Assay

CDSCO

Sub-Zone Guwahati

RDTL

Guwahati

27.

MONTERUS-L

(Montelukast Sodium & Levocetirizine Hydrochloride Tablets I.P.)

B. No.: VBGT-094 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Vats

Biotech Pvt. Ltd. Vill. Kailar, P.O. Saproon, Teh. & Distt. Solan- 173211, Himachal

Pradesh.

Dissolution and Description

Drug Control Department Jharkhand

RDTL

Guwahati

28.

Azithromycin Oral Suspension IP 200

mg/ 5 ml

B. No.: AYA-2101 Mfg dt: 01/2021 Exp dt: 12/2022

Mfd by: M/s. Apple

Assay/content of Anhydrous Azithromycin

Drug Control Department Assam

RDTL

Guwahati


Formulations Pvt. Ltd. Plot No. 208, Kishanpur, Roorkee-

247667, Uttarakhand .

29.

ACILOC 150 (RANITIDINE TABLETS IP

150 mg)

B. No.: LD21599

Mfg dt: 12/2021 Exp dt: 05/2024

Mfd by: M/s. CADILA PHARMACEUTICALS LIMITED 1389,

Dholka-382225, Dist.:

Ahmedabad, Gujarat.

Description

Drug Control Department Jharkhand

RDTL

Guwahati

30.

Azithromycin Tablets IP 500mg AZUSTAN-500

Tablets

B. No.: MGT22007B Mfg dt: 01/2022

Exp dt: 12/2023

Mfd by: M/s. Mediwell Biotech, Plot No.21

,22, Phase-IV, Himuda Industrial Township, Bhatolikala, Dist.

Solan, Himachal

Pradesh- 173205.

Dissolution

Drug Control Department Assam

RDTL

Guwahati

31.

Moxmed-500 (Amoxycillin Capsule I.P. 500mg)

B. No.: KC21103

Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. Krux

Pharma Pvt. Ltd. Plot No. 10C & 11C,

Survey No. 256/P-1, Balda Industrial Park, Village-Balda, Taluka – Pardi, Dist.-Valsad,

Gujarat – 396125.

Dissolution and Assay

Drug Control Department Assam

RDTL

Guwahati

32.

Telmisartan Tablets

I.P. 40 mg

B. No.: TETY-01 Mfg dt: 04/2021 Exp dt: 03/2023

Mfd by: M/s. NESTOR PHARMACEUTICALS

LIMITED11, Western Extension Area Faridabad-121001,

INDIA. Haryana.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

33.

AMITRYN-C

(Chlordiazepoxide and Amitriptyline

B. No.: AC2103 Mfg dt: 06/2021

Assay of Chlordiazepoxide

Drug Control

Department Bihar

RDTL

Guwahati


Hydrochloride Tablets U.S.P.)

Exp dt: 05/2024 Mfd by: M/s. K.C. LABORATORIES L-6224, G.I.D.C.

Industrial Estate, Ankleshwar 393002,

Gujarat.

34.

Thirobal -5 (Carbimazole Tablets I.P. 5 mg)

B. No.: T-01497

Mfg dt: 04/2021 Exp dt: 09/2022

Mfd by: M/s. East West Pharma (India) Private Limited, Kh. No. 196, Raipur Industrial Area , Bhagwanpur, Roorkee, Dist. Haridwar, Uttarakhand 247 661,

India.

Thiamazole and other related substances

CDSCO

South Zone Chennai

CDL

Kolkata

35.

Thirobal -5 (Carbimazole Tablets I.P. 5 mg)

B. No.: T-02099

Mfg dt: 07/2021 Exp dt: 12/2022

Mfd by: M/s. East West Pharma (India) Private Limited, Kh. No. 196, Raipur Industrial Area , Bhagwanpur, Roorkee, Dist. Haridwar, Uttarakhand 247 661,

India.

Thiamazole and other related substances

CDSCO

South Zone Chennai

CDL

Kolkata

36.

Secef - CV (Cefixime & Potassium Clavulanate Tablets)

B. No.: TPP-014 Mfg dt: 10/2021 Exp dt: 03/2023 Mfd by: M/s. Park

Pharmaceuticals, Vill. Kalujhanda, Near Nanakpur, Teh. Baddi. Dist. Solan, Himachal

Pradesh- 174 103.

Assay of Cefixime & Potassium Clavulanate

CDSCO

South Zone Chennai

CDL

Kolkata

37.

Misopres -200 (Misoprostol Tablets

I.P. 200 mcg)

B. No.: T-02095

Mfg dt: 07/2021 Exp dt: 06/2023

Mfd by: M/s. East West Pharma (India) Private Limited, Kh. No. 196,

Raipur Industrial Area ,

Assay

CDSCO,

South Zone Chennai

CDL

Kolkata


Bhagwanpur, Roorkee, Dist. Haridwar, Uttarakhand - 247 661,

India

38.

Misoprostol Tablets

I.P. 200 mcg

B. No.: UHT21422 Mfg dt: 12/2021 Exp dt: 11/2023

Mfd by: M/s. Unimarck Healthcare Ltd., Plot No. 24, 25 & 37,

Sector 6A, SIDCUL, Haridwar - 249 403,

Uttarakhand.

Assay

CDSCO

South Zone Chennai

CDL

Kolkata

39.

LEVOCET

Levocetirizine Tablets IP 5 mg

B. No.: GT22020B Mfg dt: 01/2022 Exp dt: 12/2024 Mfd by: M/s. Hetero Healthcare Limited, AIIDC Industrial Growth Centre, Changsari, Niz

Sindurighopa (Village), Sila Sindurighopa (Mouza), Kamrup (Dist.), Assam –

781 101.

Description

CDSCO

Ahmedabad

CDL

Kolkata

40.

BUDISON 0.5

Respules (Budenoside, Nebuliser Suspension BP (0.5 mg) – 2 ml

B. No.: K1090046

Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s.

Kamlaamrut Pharmaceuticals LLP, Survey No. 53, 56, 57, Nr. Kamla Amrut Industrial Park, Indrad, Ta. Kadi, Dist.

Mehsana, Gujarat –

382 715, India.

Assay & Related Substances

CDSCO

Ahmedabad

CDL

Kolkata

41.

Clopidogrel and Aspirin Tablets I.P.

B. No.: PR14AD14 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Pure &

Cure Healthcare Pvt.

Ltd., Plot No. 26A, 27-

Free Salicylic Acid (Related Substances for Aspirin)

CDSCO

Ahmedabad

CDL

Kolkata


30, Sector -8A, I.I.E.,

Sidcul, Ranipur, Haridwar – 249 403, Uttarakhand.

42.

RL 500ml

(Compound Sodium Lactate Injection IP) (Ringer Lactate Solution for Injection)

B. No.: S2FBV25 Mfg dt: 02/2022 Exp dt: 01/2024

Mfd by: M/s. Swaroop Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari Industrial Area, Aligarh

- 202 001, Uttar

Pradesh.

Bacterial endotoxins

Drug Control Department Odisha

CDL

Kolkata

43.

Flavosil -200 (Flavoxate Hydrochloride Tablets IP 200 mg)

B. No.: TT-041021

Mfg dt: 10/2021 Exp dt: 09/2023

Mfd by: M/s. Technica Labs & Pharma Pvt.

Ltd., Plot No. 100, Sector - 7, IIE, SIDCUL, Haridwar,

Uttarakhand - 249403.

Assay

CDSCO

East Zone Kolkata

CDL

Kolkata

44.

Vildazem M 1000

(Vildagliptin 50 mg & Metformin Hydrochloride 1000 mg Tablets I.P.)

B. No.: 421-1467

Mfg dt: 09/2021 Exp dt: 08/2024 Mfd by: M/s. Zee Laboratories Ltd.,

Behind 47, Industrial Area, Paonta Sahib - 173 025, Himachal

Pradesh.

Disintegration

CDSCO

East Zone Kolkata

CDL

Kolkata

45.

Losacon-H (Losartan Potassium & Hydrochlorothiazide Tablets I.P.)

B. No.: C21L262001

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

Mfd by: M/s. Concept Pharmaceuticals Ltd., A-28/3, MIDC,

Chikalthana, Aurangabad – 431006,

Maharashtra

Assay of Hydrochlorthiazide

CDSCO

East Zone Kolkata

CDL

Kolkata

46.

Alumina, Magnesia & Simethicone Tablets U.S.P.

B. No.: 2718

Mfg dt: 12/2021 Exp dt: 11/2023

Mfd by: M/s. ABICEE

Assay of Simethicone

CDSCO

East Zone Kolkata

CDL

Kolkata


Pharmaceuticals Pvt. Ltd., 217, Mancheswar Industrial Estate, Sector - A, Zone - B,

Bhubaneswar, Orissa

47.

Propoven Injection 50ml (Propofol Emulsion for Injection IP 10mg/ml)

B. No.: PNL-220316

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

Laboratories Pvt. Ltd., VPO: Mouza - Ogli, Sadhaura Road, Kala Amb, Distt. Sirmour, 173030, Himachal

Pradesh.

Assay &

Free Fatty Acid

Drug Control Department Himachal Pradesh

CDL

Kolkata

48.

Propomit Injection 20 ml (Propofol Emulsion for Injection IP 10mg/ml)

B. No.: PNL-220418

Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Nixi

Laboratories Pvt. Ltd., VPO: Mouza - Ogli, Sadhaura Road, Kala Amb, Distt. Sirmour, 173030, Himachal

Pradesh.

Free Fatty Acid

Drug Control Department Himachal Pradesh

CDL

Kolkata

49.

NEXOFOL Injection 20 ml (Propofol Emulsion for Injection IP 10mg/ml)

B. No.: PNL-220419

Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Nixi

Laboratories Pvt. Ltd., VPO: Mouza - Ogli, Sadhaura Road, Kala Amb, Distt. Sirmour, 173030, Himachal

Pradesh.

Assay

Drug Control Department Himachal Pradesh

CDL

Kolkata

50.

Ciprofloxacin Tablets IP 500 mg

B. No.: CPT22006 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Vivek

Pharmachem (India)

Ltd., NH-8,

Chimanpura, Amer, Jaipur-303102, Rajasthan.

Test for Dissolution

CDSCO

South - Zone

CDTL

Chennai


51.

Norfloxacin Tablets

I.P. 400 mg

B. No.: WT-215 Mfg dt: 11/2021 Exp dt: 10.2023

Mfd by: M/s. Wilcure Remedies Private Limited., Ph No. 10, Gram Mirzapur, Khandwa Road, Dist. Indore- 452020,

Madhya Pradesh.

Dissolution test

CDSCO

Sub – Zone Indore

CDTL

Mumbai

52.

FEXOFENADINE HCL TABLETS IP

120 mg (REFEXO

TABLETS 120 mg)

B. No.: OT-220196

Mfg dt: 05/2022 Exp dt: 04/2024

Mfd by: M/s. ORCHID BIO – TECH LIMITED

65, Peerpura- Delhi

highway, Roorkee- 247667 – Uttarakhand.

Dissolution

CDSCO

Zonal - Office Hyderabad

CDTL

Hyderabad

53.

DIVALPROEX SODIUM TABLETS IP 500 mg

B. No.: PF8AO19 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Pure &

Cure Healthcare Pvt. Ltd. Plot No. 26A, 27- 30, Sector- 8A, I.I.E,

SIDCUL, Ranipur, Haridwar-249403,

Uttarakhand.

Dissolution (Buffer stage)

CDSCO

Zonal - Office Hyderabad

CDTL

Hyderabad

54.

PROLONGED- RELEASE SODIUM VALPROATE TABLET BP 500 mg

B. No.: G210163

Mfg dt: 09/2021 Exp dt: 08/2023

Mfd by: M/s. Vee Excel Drugs & Pharmaceuticals (P) Ltd., B-1/A, Industrial Area, GNEPIP, Kasna Greater Noida Gautam Budh Nagar-201308,

Uttar Pradesh. (India).

Description

CDSCO

Zonal - Office Hyderabad

CDTL

Hyderabad

55.

ZINC SULPHATE DISPERSIBLE TABLETS IP

B. No.: ZS22001

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

CHEMICO PRIVATE

Disintegration Test

CDSCO

Sub - Zone Jammu

RDTL

Chandigarh


LIMITED Taki Road Kadambagachi, Barasat, North 24- Parganas, Kolkata

700125, West Bengal.

56.

THIOCOLCHICOSI DE CAPSULES IP

4 mg

B. No.: GC210614

Mfg dt: 09/2021 Exp dt: 08/2023

Assay

CDSCO

North - Zone

RDTL

Chandigarh

Mfd by: M/s. Theon

Pharmaceuticals Ltd.,

Village Saini Majra,

Tehsil Nalagarh, Distt.

Solan, Himachal

Pradesh -174101.

57.

POVIDONE IODINE SOLUTION IP

10% W/V

B. No.: 2103001

Mfg dt: 04/2022 Exp dt: 09/2023

pH and Assay

CDSCO

Sub - Zone Baddi

RDTL

Chandigarh

Mfd by: M/s. BENGAL

CHEMICALS &

PHARMACEUTICALS

LTD. (A Govt. Of India

Enterprise) 164,

Maniktala Main Road,

Kolkata-700054

58.

Propofol Emulsion for Injection IP 10 mg/ml (PROPOVEN INJECTION )

B. No.: PNL-220316

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

Laboratories Pvt. Ltd.

VPO: Mouza Ogli,

Description, pH, Propofol dimer, Free fatty acid, Bacterial Endotoxins Sterility

CDSCO

Sub - Zone Baddi

RDTL

Chandigarh

Sadhaura Road, Kala-

Amb, Distt. Sirmour-

173030, Himachal

Pradesh.

59.

Propofol Injection IP 1%w/v (NEOROF INJECTION )

B. No.: 340160

Mfg dt: 01/2022 Exp dt: 12/2023

pH

CDSCO

Sub Zone Baddi

RDTL

Chandigarh

Mfd by: M/s. NEON

LABORATORIES

LIMITED 28 Mahal Ind.

Est., M.Caves Rd.,

Andheri (East),

Mumbai-400093.


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