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20jan20 PDF

The document lists various companies and the type of letters they received from regulatory authorities. It includes sections for international cell, BE NOC for export, new drug, FDC division, biological division, diagnostic division, medical device division, global clinical trial, and subsequent new drug. The types of letters mentioned include approval, amendment, acknowledgment, clarification, deficiency, and invitation letters.

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Hari Thekkethil
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84 views

20jan20 PDF

The document lists various companies and the type of letters they received from regulatory authorities. It includes sections for international cell, BE NOC for export, new drug, FDC division, biological division, diagnostic division, medical device division, global clinical trial, and subsequent new drug. The types of letters mentioned include approval, amendment, acknowledgment, clarification, deficiency, and invitation letters.

Uploaded by

Hari Thekkethil
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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TODAY LETTER DATED 20.01.

2020

INTERNATIONAL CELL
S. NO NAME OF FIRM TYPE
1 M/S. PHAEX POLYMERS PVT LTD WC
MUMBAI
2 M/S. PHAEX POLYMERS PVT LTD LETTER
MUMBAI
3 M/S. CLIANTHA RESEARCH LTD LETTER
AHMEDABAD
4 M/S. MICRO LABS LTD WC
BENGALURU
5 M/S. HALCYON LABS PVT LTD LETTER
AHMEDABAD
6 M/S. MALLADI DRUGS & PHARMACEUTICALS LTD LETTER
ANDHRA PRADESH
7 M/S. AASHISH LIFE SCIENCES PVT LTD LETTER
PALGHAR
8 M/S. LIFESAN CLINICAL RESEARCH APPROVAL LETTER
MUMBAI
9 M/S. SOLARA ACTIVE PHARMA SCIENCES PVT LTD LETTER
CUDDALORE

BE NOC FOR EXPORT

S. NO. NAME OF THE COMPANY REF. NO. TYPE OF LETTER

1. M/S. ACTIMUS BIOSCIENCES PVT. LTD., ANDHRA 36316 (16891, 254) AMENDMENT LETTER
PRADESH-530003
2. M/S. AUROBINDO PHARMA LIMITED, TELANGANA- 202 AMENDMENT LETTER +
500038 TEST LICENCE
3. M/S. CLIANTHA RESEARCH LIMITED, AHMEDABAD- 261 AMENDMENT LETTER
380054
4. M/S. LAMBDA THERAPEUTIC RESEARCH LTD., 450 ACKNOWLEDGEMENT
GUJARAT-382481 LETTER
5. M/S. LIFESAN CLINICAL RESEARCH, MAHARASHTRA- 268, 408 AMENDMENT LETTER
400055
6. M/S. LUPIN LIMITED, MUMBAI-400055, 17144 (373) AMENDMENT LETTER
MAHARASHTRA
NEW DRUG
S.NO. NAME OF APPLICANT DIARY NO. TYPE OF LETTER
1. M/S. SERDIA PHARMA - CT NOC

2. M/S. THEMIS MEDICARE LTD - AMENDMENT

3. M/S. PRECISE - PERMISSION

FDC DIVISION
S.NO. NAME OF COMPANY DIARY NO. DOCUMENT
1. M/S. AJANTA PHARMA NIL LETTER

2. M/S. SEPTODONT HEALTHCARE 16752 LETTER

3. M/S. NEON LABORATORIES 5622 LETTER

4. M/S. INNOVA CAPTAB 15685 LETTER

BIOLOGICAL DIVISION

S. NO. NAME OF FIRM REFERENCE NO. TYPE OF LETTER


1 M/S SERUM INSTITUTE OF INDIA 158 APPROVAL LETTER
PVT, LTD
2 M/S CADILA HEALTHCARE LTD 14381 OM LETTER
3 M/S ENZENE BIOSCIENCES, LTD 16595 APPROVAL LETTER
4 M/S INTAS PHARMACEUTICALS LTD 292 APPROVAL LETTER
5 M/S BIOCON BIOLOGICS INDIA LTD 15634 CLARIFICATION LETTER
6 M/S ELI LILLY AND COMPANY INDIA 15720 CLARIFICATION LETTER
PVT, LTD
7 M/S JOHNSON & JOHNSON PVT, LTD 15585 ACKNOWLEDGE LETTER
8 M/S EISAI PHARMACEUTICALS INDIA 15081, 15082 ACKNOWLEDGE LETTER
PVT, LTD
9 M/S STEMPEUTICS RESEARCH PVT, CLARIFICATION LETTER
LTD
10 M/S OCT THERAPIES AND RESEARCH CLARIFICATION LETTER
PVT, LTD
11 M/S USV PVT, LTD 16023 ACKNOWLEDGE LETTER
12 M/S GREEN SIGNAL BIO PHARMA 129 CLARIFICATION LETTER
PVT, LTD
13 M/S WOCKHARDT LTD 6300 ACKNOWLEDGE LETTER
14 M/S BIOLOGICAL E. LTD 17368 APPROVAL LETTER
15 M/S ABBOTT INDIA LTD 104 CONTINUATION LETTER
16 M/S VENKY PARENTERALS P. NO.1328853 APPROVAL LETTER
ADVIPOLAM

DIAGNOSTIC DIVISION
S. NO. COMPANY NAME DIARY NO. STATUS
1. M/S SIEMENS HEALTHCARE PVT LTD 15716 LETTER

2. M/S MERIL DIAGNOSTICS PVT. LTD 17312 LETTER

MEDICAL DEVICE DIVISION

S.NO. COMPANY NAME DIARY NO STATUS


1. M/S. AUROLAB, 153 LETTER (NC)
THE DEPUTY DRUGS CONTROLLER, CHENNAI
THE STATE DRUGS CONTROLLER, CHENNAI
2. M/S. ROMSONS SCIENTIFIC & SURGICAL INDIA PVT. LTD., NIL LETTER

GLOBAL CLINICAL TRIAL


SR. NO. COMPANY NAME REFERENCE NO. STATUS

1 M/S. MAYA CLINICALS 306 TL APPROVAL LETTER

2 NIRT 558 TL APPROVAL LETTER

SUBSEQUENT NEW DRUG

S. NO. NAME OF THE FIRM REFERENCE NO. COMPUTER TYPE OF LETTER


NO.

1. M/S TORRENT - - IPC NOC


PHARMACEUTICALS
LIMITED.,
2. M/S MAITHRI - - IPC NOC
LABORATORIES PRIVATE
LIMITED.,
3. M/S AQUA VITOE - - IPC NOC
4. M/S THIQ PHARMA 986025 - DEFICIENCY LETTER
5. M/S SOLARA ACTIVE 1572487 - DEFICIENCY LETTER
6. M/S SERIDA - - SEC INVITATION LETTER FOR
UPCOMING SEC
GASTROENTEROLOGY &
HEPATOLOGY

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